legislation

Human Medicines Regulations 2012

Verified at publication, 2026-11-12 10:28 UTC

1305 provisions in 144 parts · official text ↗

No overall summary yet: some parts of this source have not passed verification. The part summaries that did pass and the full text of every provision are below.

Part summaries

0 of 0 parts have a verified summary.

L1 unavailable for current verification: the overall summary needs every part verified. Provisions and the verified summaries remain readable.

Verification findings (1458)

synthesis coverage: missing/unverified L2 part-1

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-1

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-2

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-2A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-3

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-3A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-4

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-5

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-6

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-7

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-8-part-1

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-8-part-2

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-8-part-3

synthesis coverage: missing/unverified L2 part-2

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-9

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-10

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-11

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-12

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-13

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-14

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-15

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-16

synthesis coverage: missing/unverified L2 part-3-chapter-1

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-A17

synthesis coverage: missing/unverified L2 part-3-chapter-1A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-B17

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-C17

synthesis coverage: missing/unverified L2 part-3-chapter-2

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-17

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-17A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-17B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-18

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-18A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-19

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-20

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-21

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-22

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-23

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-24

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-25

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-26

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-27

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-27A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-28

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-29

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-29A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-29B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-30

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-31

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-32

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-33

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-34

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-35

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-36

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-37

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-37A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-37B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-38

synthesis coverage: missing/unverified L2 part-3-chapter-2

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-39

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-40

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-41

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-42

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-43

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-43ZA

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-43A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-44

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45AA

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45AB

synthesis coverage: missing/unverified L2 part-3-chapter-3

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45C

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45D

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45E

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45F

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45G

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45H

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45I

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45J

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45K

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45L

synthesis coverage: missing/unverified L2 part-3-chapter-4

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45M

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45N

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45O

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45P

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45Q

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45R

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45S

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45T

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45U

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45V

synthesis coverage: missing/unverified L2 part-4

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-46

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-47

synthesis coverage: missing/unverified L2 part-5

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-48

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-49

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50C

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50D

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50E

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50F

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50G

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50H

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50I

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50J

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50K

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-51

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-51A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-51B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-52

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-52A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-52B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-53

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-53A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-53B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-54

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-55

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-56

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-57

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-57A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58A

synthesis coverage: missing/unverified L2 part-5

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58C

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58D

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58E

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58F

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58G

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-59

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-60

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-60A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-60B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-61

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-62

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-63

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-64

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-64A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-65

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-65A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-65B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-65C

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-66

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-66A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-66B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-67

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-68

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-69

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-70

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-71

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-72

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-73

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-74

synthesis coverage: missing/unverified L2 part-5

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-74A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-74B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-75

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-76

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-77

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-78

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-78A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-78B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-79

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-80

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-80A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-A81

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-81

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-82

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-83

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-84

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-85

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-86

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-87

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-88

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-89

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-90

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-91

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-92

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-93

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-94

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-94A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-95

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-95A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-96

synthesis coverage: missing/unverified L2 part-5

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-97

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-98

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-99

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-100

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-101

synthesis coverage: missing/unverified L2 part-6

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-102

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-103

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-104

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-105

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-106

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-107

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-108

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-109

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-110

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-111

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-112

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-113

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-114

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-115

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-116

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-117

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-118

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-119

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-120

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-121

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-122

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-123

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-124

synthesis coverage: missing/unverified L2 part-7

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-124A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-125

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-125A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-126

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-126A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-127

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-128

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-129

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-130

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-130A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-131

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-132

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-133

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-134

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-135

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-136

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-137

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-138

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-139

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-140

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-141

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-142

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-143

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-143A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-144

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-145

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-146

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-147

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-148

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-148A

synthesis coverage: missing/unverified L2 part-7

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-149

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-150

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-151

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-152

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-153

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-154

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-155

synthesis coverage: missing/unverified L2 part-8

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-156

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-157

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-158

synthesis coverage: missing/unverified L2 part-9

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-159

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-160

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-161

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-162

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-163

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-164

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-165

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-166

synthesis coverage: missing/unverified L2 part-10

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167C

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167D

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167E

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167F

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167G

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167H

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-168

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-169

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-170

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-170A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-170B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-171

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-172

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-173

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-174

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-174A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-175

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-176

synthesis coverage: missing/unverified L2 part-11

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-177

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-178

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-179

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-180

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-181

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-182

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-183

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-184

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-185

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-186

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-186A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-187

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-188

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-189

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-190

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-191

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-191A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-192

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-193

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-194

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-195

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-196

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-196A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-197

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-198

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-199

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-200

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-201

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-202

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-202A

synthesis coverage: missing/unverified L2 part-11

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-203

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-204

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-205

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-205A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-205B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-206

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-207

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-208

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-209

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-210

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-210A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-211

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-212

synthesis coverage: missing/unverified L2 part-12-chapter-1

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-213

synthesis coverage: missing/unverified L2 part-12-chapter-2

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-214

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-215

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-216

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-217

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-217A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-217B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-217BA

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-217C

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-217CA

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-218

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-219

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-219A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-220

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-220B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-221

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-222

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-222A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-222B

synthesis coverage: missing/unverified L2 part-12-chapter-3

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-223

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-224

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-225

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-226

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-226A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-227

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-228

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-229

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-230

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-231

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-232

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-233

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-234

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-235

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-235A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-236

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-237

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-237A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-238

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-239

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synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-65

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-66

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-67

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-68

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-69

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-70

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-71

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-72

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-73

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-74

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-75

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-76

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-77

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-78

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-79

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-80

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-81

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-82

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-83

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-84

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-85

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-86

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-87

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-88

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-89

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-90

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-91

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-92

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-93

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-94

synthesis coverage: missing/unverified L2 schedule-34-part-5

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-95

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-96

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-97

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-98

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-99

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-100

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-101

synthesis coverage: missing/unverified L2 schedule-34-part-6

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-102

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-103

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-104

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-105

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-106

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-107

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-108

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-109

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-110

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-111

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-112

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-113

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-114

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-115

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-116

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-117

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-118

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-119

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-120

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-121

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-122

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-123

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-124

Instrument tier unavailable

Change history as published

Reg. 32 revoked (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 35

Reg. 43A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 19

Reg. 51A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 35

Reg. 52A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 38

Reg. 53A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 41

Reg. 60B omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 50

Reg. 70 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 79; 2020 c. 1, Sch. 5 para. 1(1)

Regs. 81-88 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 65 · repeated 8×

Reg. 91 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 90B (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 67)

Reg. 94A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 66

Reg. 111 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 103; 2020 c. 1, Sch. 5 para. 1(1)

Reg. 139 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 122; 2020 c. 1, Sch. 5 para. 1(1)

Reg. 210 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 98

Reg. 247A omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 10

Reg. 255A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 109(a)

Reg. 255B omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 109(b)

Reg. 255C omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 109(c)

Reg. 257A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 112

Reg. 257B omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 113

Sch. 11 para. 31 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 63(9) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(e))

Sch. 11 para. 34 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 63(9) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(e))

Sch. 11 para. 35 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 63(9) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(e))

Sch. 11 para. 37 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 63(9) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(e))

Sch. 11 para. 38 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 63(9) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(e))

Sch. 24 para. 18A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 142(d)

Sch. 33 para. 1 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 178; 2020 c. 1, Sch. 5 para. 1(1)

Sch. 33 para. 2 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 178; 2020 c. 1, Sch. 5 para. 1(1)

Sch. 33 paras. 5-10 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 178 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 140); 2020 c. 1, Sch. 5 para. 1(1) · repeated 6×

Sch. 33A para. 29A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 145

Sch. 34 para. 78 revoked (1.4.2022) by The Medicines and Healthcare Products Regulatory Agency Trading Fund (Revocation) Order 2022 (S.I. 2022/90), art. 1, Sch.

Sch. 34 para. 85 revoked (E.) (7.12.2015) by The National Health Service (General Medical Services Contracts) Regulations 2015 (S.I. 2015/1862), reg. 1(2), Sch. 5 (with reg. 2)

Sch. 34 para. 87 revoked (E.) (7.12.2015) by The National Health Service (Personal Medical Services Agreements) Regulations 2015 (S.I. 2015/1879), reg. 1(2), Sch. 4 (with regs. 2, 88)

Pending effects amendments not yet applied to this text

reg. 38 heading words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 29(2) · Effective date unknown

reg. 149 heading word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 131(2) · Effective date unknown

Pt. 8 omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 132 · Effective date unknown

reg. 210A heading words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 175(2) · Effective date unknown

reg. 196 and cross-heading substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 156 · Effective date unknown

Show all 200

Pt. 12A omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 197 · Effective date unknown

reg. 3(12)(d)(ii) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 5(2)(b) · Effective date unknown · reg. 3

reg. 3(12)(d)(iv) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 5(2)(c) · Effective date unknown · reg. 3

reg. 3(15)(b) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 5(3)(b) · Effective date unknown · reg. 3

reg. 3(15)(d) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 5(3)(c) · Effective date unknown · reg. 3

reg. 5(1)(b) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(2) · Effective date unknown · reg. 5

reg. 5(2)(b) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(3)(a) · Effective date unknown · reg. 5

reg. 5(2)(d) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(3)(b) · Effective date unknown · reg. 5

reg. 5(3)(b) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(4)(a) · Effective date unknown · reg. 5

reg. 5(3)(d) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(4)(b) · Effective date unknown · reg. 5

reg. 5(4)(b) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(5) · Effective date unknown · reg. 5

reg. 5(5)(b) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(6)(a) · Effective date unknown · reg. 5

reg. 5(5)(d) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(6)(b) · Effective date unknown · reg. 5

reg. 6(3)(b) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 9(a) · Effective date unknown · reg. 6

reg. 6(4) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 9(b) · Effective date unknown · reg. 6

reg. 6(5) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 9(b) · Effective date unknown · reg. 6

reg. 8(1) words inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 10(3)(a) · Effective date unknown

reg. 8(1) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 10(3)(d) · Effective date unknown

reg. 17(1)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 14(2) · Effective date unknown · reg. 17

reg. 17(3)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 14(3) · Effective date unknown · reg. 17

reg. 17(4) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 14(4) · Effective date unknown · reg. 17

reg. 17(5) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 14(5) · Effective date unknown · reg. 17

reg. 18(1)(c) words omitted by virtue of S.I. 2019/775, reg. 15(2)(c) (as amended) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 2 · Effective date unknown · reg. 18

reg. 18(6) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 15(3) · Effective date unknown · reg. 18

reg. 18(7) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 15(4) · Effective date unknown · reg. 18

reg. 19(1)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 17(2) · Effective date unknown · reg. 19

reg. 19(6) inserted by S.I. 2019/775, reg. 17(4) (as inserted) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 3 · Effective date unknown · reg. 19

reg. 26(5)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 21 · Effective date unknown · reg. 26

reg. 31(5)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 24(3) · Effective date unknown · reg. 31

reg. 36(4)-(7) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 27 · Effective date unknown · reg. 36

reg. 37(4)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 28(2)(a) · Effective date unknown · reg. 37

reg. 37(5)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 28(3) · Effective date unknown · reg. 37

reg. 37(6)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 28(4) · Effective date unknown · reg. 37

reg. 38(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 29(3) · Effective date unknown · reg. 38

reg. 38(3)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 29(3) · Effective date unknown · reg. 38

reg. 42(1) word substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 31(2) · Effective date unknown · reg. 42

reg. 42(4) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 31(3) · Effective date unknown · reg. 42

reg. 43(1) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(2) · Effective date unknown · reg. 43

reg. 43(5)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(3) · Effective date unknown · reg. 43

reg. 43(6)(b) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(4)(b) · Effective date unknown · reg. 43

reg. 43(7)(b)(i) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(5)(a)(i) · Effective date unknown · reg. 43

reg. 43(7)(b)(ii) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(3) · Effective date unknown · reg. 43

reg. 43(7)(c)(vii) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(5)(b) · Effective date unknown · reg. 43

reg. 43(8)(8A) substituted for reg. 43(8) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(6) · Effective date unknown · reg. 43

reg. 43(10) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(7) · Effective date unknown · reg. 43

reg. 43(11) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(7) · Effective date unknown · reg. 43

reg. 43(13) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(8) · Effective date unknown · reg. 43

reg. 43(15) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(9) · Effective date unknown · reg. 43

reg. 43A omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 34 · Effective date unknown · reg. 43A

reg. 44(2)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 35(2)(a) · Effective date unknown · reg. 44

reg. 44(2)(c) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 35(2)(b) · Effective date unknown · reg. 44

reg. 44(5)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 35(3) · Effective date unknown · reg. 44

reg. 44(5)(e) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 35(4)(a) · Effective date unknown · reg. 44

reg. 44(6)(e) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 35(5)(b) · Effective date unknown · reg. 44

reg. 45(1) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 36(2) · Effective date unknown · reg. 45

reg. 45(2)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 36(3) · Effective date unknown · reg. 45

reg. 45A(1)(a)(i)(ii) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 38(2)(a) · Effective date unknown · reg. 45A

reg. 45A(1)(b)(i) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 38(2)(b)(i) · Effective date unknown · reg. 45A

reg. 45A(1)(b)(ii) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 38(2)(b)(ii) · Effective date unknown · reg. 45A

reg. 45A(1)(b)(iii) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 38(2)(b)(iii) · Effective date unknown · reg. 45A

reg. 45A(2)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 38(3)(a) · Effective date unknown · reg. 45A

reg. 45A(2)(c) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 38(3)(b) · Effective date unknown · reg. 45A

reg. 45E(3)(b)(i) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 40(a) · Effective date unknown · reg. 45E

reg. 45E(3)(d)(iii) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 40(b) · Effective date unknown · reg. 45E

reg. 45M(2)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 42(2) · Effective date unknown · reg. 45M

reg. 45O(1) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(2) · Effective date unknown · reg. 45O

reg. 45O(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(3) · Effective date unknown · reg. 45O

reg. 45O(3) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(4)(a) · Effective date unknown · reg. 45O

reg. 45O(3)(c) word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(4)(c)(i) · Effective date unknown · reg. 45O

reg. 45O(3)(c)(ii) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(4)(c)(ii) · Effective date unknown · reg. 45O

reg. 45O(3)(c)(iii) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(4)(c)(iii) · Effective date unknown · reg. 45O

reg. 45O(4)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(5)(a) · Effective date unknown · reg. 45O

reg. 45O(4)(b)(i) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(5)(b) · Effective date unknown · reg. 45O

reg. 46(2)(b) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 45(2)(b) · Effective date unknown · reg. 46

reg. 46(2)(d) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 45(2)(c) · Effective date unknown · reg. 46

reg. 46(6)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 45(4)(a) · Effective date unknown · reg. 46

reg. 46(6)(b) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 45(4)(b) · Effective date unknown · reg. 46

reg. 46(6)(d) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 45(4)(c) · Effective date unknown · reg. 46

reg. 46(7)(b) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 45(5) · Effective date unknown · reg. 46

reg. 47(6) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 46(3) · Effective date unknown · reg. 47

reg. 48(2) words inserted by S.I. 2019/775, reg. 47(2)(a) (as amended) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 4(a) · Effective date unknown · reg. 48

reg. 48(2) words omitted by virtue of S.I. 2019/775, reg. 47(2)(d) (as amended) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 4(b)(i) · Effective date unknown · reg. 48

reg. 48(2) words inserted by S.I. 2019/775, reg. 47(2)(d) (as amended) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 4(b)(ii) · Effective date unknown · reg. 48

reg. 49(1A) inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 48(3) · Effective date unknown · reg. 49

reg. 49(3) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 48(4) · Effective date unknown · reg. 49

reg. 49(9) inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 48(6) · Effective date unknown · reg. 49

reg. 50(4) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 49(2) · Effective date unknown · reg. 50

reg. 51 substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 56 · Effective date unknown · reg. 51

reg. 51(9) words inserted by S.I. 2019/775, reg. 56 (as amended) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 5 · Effective date unknown · reg. 51

reg. 52(1)(a)(i)(ii) and words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 57(2) · Effective date unknown · reg. 52

reg. 52(1)(b) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 57(3) · Effective date unknown · reg. 52

reg. 52(2) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 57(4) · Effective date unknown · reg. 52

reg. 52(3) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 57(5)(a) · Effective date unknown · reg. 52

reg. 53(1) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 58(2) · Effective date unknown · reg. 53

reg. 53(2)-(2C) substituted for reg. 53(2) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 58(3) · Effective date unknown · reg. 53

reg. 53(2)(a) substituted by S.I. 2019/775, reg. 58(3) (as amended) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 6(2) · Effective date unknown · reg. 53

reg. 53(3) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 58(4)(a) · Effective date unknown · reg. 53

reg. 53(3) words substituted by S.I. 2019/775, reg. 58(4)(a) (as substituted) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 6(3) · Effective date unknown · reg. 53

reg. 55(1)(a) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 60(2) · Effective date unknown · reg. 55

reg. 55(2) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 60(3) · Effective date unknown · reg. 55

reg. 58(6) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 62(3) · Effective date unknown · reg. 58

reg. 58(7) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 62(3) · Effective date unknown · reg. 58

reg. 59(3) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 65(2) · Effective date unknown · reg. 59

reg. 59(3A)(3B) inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 65(3) · Effective date unknown · reg. 59

reg. 59(5) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 65(6) · Effective date unknown · reg. 59

reg. 60(9) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 66 · Effective date unknown · reg. 60

reg. 60A inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 67 · Effective date unknown · reg. 60A

reg. 61(6) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 68(3) · Effective date unknown · reg. 61

reg. 61(7)-(7B) substituted for reg. 61(7) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 68(4) · Effective date unknown · reg. 61

reg. 61(13) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 68(5) · Effective date unknown · reg. 61

reg. 64(4)(d) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 69 · Effective date unknown · reg. 64

reg. 66(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 74 · Effective date unknown · reg. 66

reg. 68(7) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 77(3)(b) · Effective date unknown · reg. 68

reg. 68(9) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 77(5) · Effective date unknown · reg. 68

reg. 71(1)(b) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 80(2)(b)(i) · Effective date unknown · reg. 71

reg. 71(1)(b) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 80(2)(b)(ii) · Effective date unknown · reg. 71

reg. 72(1) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 81 · Effective date unknown · reg. 72

reg. 73(5C) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 82(3) · Effective date unknown · reg. 73

reg. 76(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 84 · Effective date unknown · reg. 76

reg. 77 word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 85 · Effective date unknown · reg. 77

reg. 78 word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 86 · Effective date unknown · reg. 78

reg. 79 omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 88 · Effective date unknown · reg. 79

reg. 80(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 89(3) · Effective date unknown · reg. 80

reg. 80(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 89(4) · Effective date unknown · reg. 80

reg. 80(c) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 89(5) · Effective date unknown · reg. 80

reg. 81-94 omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 90 · Effective date unknown

reg. 94A omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 91 · Effective date unknown · reg. 94A

reg. 95 word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 92(2) · Effective date unknown · reg. 95

reg. 95(c) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 92(3) · Effective date unknown · reg. 95

reg. 95(d) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 92(3) · Effective date unknown · reg. 95

reg. 96(1) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 93(2)(a) · Effective date unknown · reg. 96

reg. 96(1)(b) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 93(2)(b) · Effective date unknown · reg. 96

reg. 96(1)(c) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 93(2)(b) · Effective date unknown · reg. 96

reg. 96(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 93(3) · Effective date unknown · reg. 96

reg. 97 words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 94(2)(a) · Effective date unknown · reg. 97

reg. 98(2)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 95 · Effective date unknown · reg. 98

reg. 99(1) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 96(2) · Effective date unknown · reg. 99

reg. 99(2) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 96(3) · Effective date unknown · reg. 99

reg. 101(1) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 97(2) · Effective date unknown · reg. 101

reg. 101(3) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 97(3) · Effective date unknown · reg. 101

reg. 103(4) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 99(2) · Effective date unknown · reg. 103

reg. 104(5) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 100 · Effective date unknown · reg. 104

reg. 104(6) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 100 · Effective date unknown · reg. 104

reg. 108(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 101 · Effective date unknown · reg. 108

reg. 110(7) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 102(2) · Effective date unknown · reg. 110

reg. 110(10) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 102(3) · Effective date unknown · reg. 110

reg. 116(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 107 · Effective date unknown · reg. 116

reg. 125(5)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 110 · Effective date unknown · reg. 125

reg. 127(3) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 113 · Effective date unknown · reg. 127

reg. 128(3) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 114 · Effective date unknown · reg. 128

reg. 130(7) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 116(3) · Effective date unknown · reg. 130

reg. 130(8) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 116(4) · Effective date unknown · reg. 130

reg. 130(9) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 116(5) · Effective date unknown · reg. 130

reg. 130(10)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 116(6) · Effective date unknown · reg. 130

reg. 130(12) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 116(7) · Effective date unknown · reg. 130

reg. 130(13) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 116(7) · Effective date unknown · reg. 130

reg. 133(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 118 · Effective date unknown · reg. 133

reg. 135(7)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 119(2) · Effective date unknown · reg. 135

reg. 135(8) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 119(3) · Effective date unknown · reg. 135

reg. 135(9)(b) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 119(4) · Effective date unknown · reg. 135

reg. 136(1)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 120(2) · Effective date unknown · reg. 136

reg. 140(1)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 123 · Effective date unknown · reg. 140

reg. 142(5C) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 125 · Effective date unknown · reg. 142

reg. 144 words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 127 · Effective date unknown · reg. 144

reg. 146(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 129 · Effective date unknown · reg. 146

reg. 149(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 131(3) · Effective date unknown · reg. 149

reg. 149(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 131(4) · Effective date unknown · reg. 149

reg. 149(c) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 131(5) · Effective date unknown · reg. 149

reg. 159(1) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 133(b) · Effective date unknown · reg. 159

reg. 164(2)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 134(b) · Effective date unknown · reg. 164

reg. 168(8)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 135(a) · Effective date unknown · reg. 168

reg. 168(8)(b) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 135(b) · Effective date unknown · reg. 168

reg. 169(9)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 136 · Effective date unknown · reg. 169

reg. 171(2)(c) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 137 · Effective date unknown · reg. 171

reg. 173(c) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 138 · Effective date unknown · reg. 173

reg. 177(1) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(2)(a) · Effective date unknown · reg. 177

reg. 177(1) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(2)(b) · Effective date unknown · reg. 177

reg. 177(1)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(2)(c) · Effective date unknown · reg. 177

reg. 177(1)(c) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(2)(d) · Effective date unknown · reg. 177

reg. 177(2)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(3)(b) · Effective date unknown · reg. 177

reg. 177(2)(c) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(3)(c) · Effective date unknown · reg. 177

reg. 177(3)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(4)(b) · Effective date unknown · reg. 177

reg. 177(3)(c) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(4)(c) · Effective date unknown · reg. 177

reg. 177(4) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(5) · Effective date unknown · reg. 177

reg. 177(5) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(6) · Effective date unknown · reg. 177

reg. 177(5) words substituted by S.I. 2019/775, reg. 139(6)(a) (as substituted) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 8 · Effective date unknown · reg. 177

reg. 177(5) word omitted by virtue of S.I. 2019/775, reg. 139(6)(b) (as substituted) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 8 · Effective date unknown · reg. 177

reg. 177(5) words inserted by S.I. 2019/775, reg. 139(6)(c) (as substituted) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 8 · Effective date unknown · reg. 177

reg. 177(5) word omitted by virtue of S.I. 2019/775, reg. 139(6)(d) (as substituted) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 8 · Effective date unknown · reg. 177

reg. 181 omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 141 · Effective date unknown · reg. 181

reg. 182(2)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 142(2) · Effective date unknown · reg. 182

reg. 182(3) words inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 142(3) · Effective date unknown · reg. 182

reg. 186(1)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 145(a) · Effective date unknown · reg. 186

reg. 186(1)(c)-(e) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 145(b) · Effective date unknown · reg. 186

reg. 187(1) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 147(2) · Effective date unknown · reg. 187

Full TOC · table of contents Collapse parts

144 parts · 1305 provisions. Open a provision for its text and, where available, its one-line summary.

PART 1 General · 12 provisions

1 Citation and commencement uk:uksi/2012/1916#regulation-1

2 Medicinal products uk:uksi/2012/1916#regulation-2

2A Definition of advanced therapy medicinal product etc. uk:uksi/2012/1916#regulation-2A

3 Scope of these Regulations: special provisions uk:uksi/2012/1916#regulation-3

3A Preparation and assembly of medicinal products used for vaccination against an infectious disease or in the reformulation of such products uk:uksi/2012/1916#regulation-3A

4 Special provisions for pharmacies etc uk:uksi/2012/1916#regulation-4

5 Classification of medicinal products uk:uksi/2012/1916#regulation-5

6 The licensing authority and the Ministers uk:uksi/2012/1916#regulation-6

7 Advertisements relating to medicinal products uk:uksi/2012/1916#regulation-7

8 General interpretation uk:uksi/2012/1916#regulation-8-part-1

8 General interpretation uk:uksi/2012/1916#regulation-8-part-2

8 General interpretation uk:uksi/2012/1916#regulation-8-part-3

PART 2 Administration · 8 provisions

9 Commission on Human Medicines uk:uksi/2012/1916#regulation-9

10 Functions of the Commission uk:uksi/2012/1916#regulation-10

11 British Pharmacopoeia Commission uk:uksi/2012/1916#regulation-11

12 Reporting to Ministers uk:uksi/2012/1916#regulation-12

13 Co-option of additional members of advisory bodies uk:uksi/2012/1916#regulation-13

14 Appointment of expert advisory groups uk:uksi/2012/1916#regulation-14

15 Delegation of functions to expert advisory groups uk:uksi/2012/1916#regulation-15

16 Further provision about advisory bodies and expert advisory groups etc uk:uksi/2012/1916#regulation-16

CHAPTER 1 Interpretation · 1 provisions

A17 Interpretation uk:uksi/2012/1916#regulation-A17

Chapter 1A Good manufacturing practice and good distribution practice · 2 provisions

B17 Regulations on good manufacturing practice uk:uksi/2012/1916#regulation-B17

C17 Guidelines on good manufacturing practice and good distribution practice uk:uksi/2012/1916#regulation-C17

CHAPTER 2 Manufacturing and wholesale dealing · 41 provisions

17 Manufacturing of medicinal products uk:uksi/2012/1916#regulation-17

17A Manufacturing of MM medicinal products uk:uksi/2012/1916#regulation-17A

17B Manufacturing of POC medicinal products uk:uksi/2012/1916#regulation-17B

18 Wholesale dealing in medicinal products uk:uksi/2012/1916#regulation-18

18A Approved country for import uk:uksi/2012/1916#regulation-18A

19 Exemptions from requirement for wholesale dealer's licence uk:uksi/2012/1916#regulation-19

20 Mixing of medicines uk:uksi/2012/1916#regulation-20

21 Application for manufacturer's or wholesale dealer's licence uk:uksi/2012/1916#regulation-21

22 Factors relevant to determination of application for manufacturer's or wholesale dealer's licence uk:uksi/2012/1916#regulation-22

23 Grant or refusal of licence uk:uksi/2012/1916#regulation-23

24 Standard provisions of licences uk:uksi/2012/1916#regulation-24

25 Duration of licence uk:uksi/2012/1916#regulation-25

26 General power to suspend, revoke or vary licences uk:uksi/2012/1916#regulation-26

27 Procedure where licensing authority proposes to suspend, revoke or vary licence uk:uksi/2012/1916#regulation-27

27A Effect of suspension or variation relating to modular unit or POC site uk:uksi/2012/1916#regulation-27A

28 Suspension of licence in cases of urgency uk:uksi/2012/1916#regulation-28

29 Variation of licence on the application of the holder uk:uksi/2012/1916#regulation-29

29A Variation of MM master file uk:uksi/2012/1916#regulation-29A

29B Variation of POC master file uk:uksi/2012/1916#regulation-29B

30 Provision of information uk:uksi/2012/1916#regulation-30

31 Certification of manufacturer's licence uk:uksi/2012/1916#regulation-31

32 Sale and supply of starting materials uk:uksi/2012/1916#regulation-32

33 Offence concerning data for advanced therapy medicinal products uk:uksi/2012/1916#regulation-33

34 Offences: breach of regulations and false information and defence concerning starting materials uk:uksi/2012/1916#regulation-34

35 Penalties uk:uksi/2012/1916#regulation-35

36 Conditions for manufacturer's licence uk:uksi/2012/1916#regulation-36

37 Manufacturing and assembly uk:uksi/2012/1916#regulation-37

37A Manufacturing and assembly of MM medicinal products: additional requirements uk:uksi/2012/1916#regulation-37A

37B Manufacturing and assembly of POC medicinal products: additional requirements uk:uksi/2012/1916#regulation-37B

38 Imports from states other than EEA States / countries other than approved countries for import uk:uksi/2012/1916#regulation-38

39 Further requirements for manufacturer's licence uk:uksi/2012/1916#regulation-39

40 Obligation to provide information relating to control methods uk:uksi/2012/1916#regulation-40

41 Requirements as to qualified persons uk:uksi/2012/1916#regulation-41

42 Conditions for wholesale dealer's licence uk:uksi/2012/1916#regulation-42

43 Obligations of licence holder uk:uksi/2012/1916#regulation-43

43ZA Obligations of licence holder in Great Britain supplying listed NIMAR products to Northern Ireland uk:uksi/2012/1916#regulation-43ZA

43A Requirement for wholesale dealers to decommission the unique identifier uk:uksi/2012/1916#regulation-43A

44 Requirement for wholesale dealers to deal only with specified persons uk:uksi/2012/1916#regulation-44

45 Requirement as to responsible persons uk:uksi/2012/1916#regulation-45

45AA Requirement as to responsible persons where licence holder imports from an approved country for import uk:uksi/2012/1916#regulation-45AA

45AB Register for responsible persons (import) uk:uksi/2012/1916#regulation-45AB

CHAPTER 3 Brokering · 12 provisions

45A Brokering in medicinal products uk:uksi/2012/1916#regulation-45A

45B Application for brokering registration uk:uksi/2012/1916#regulation-45B

45C Procedure for determining an application for broker’s registration uk:uksi/2012/1916#regulation-45C

45D Grant or refusal of broker’s registration uk:uksi/2012/1916#regulation-45D

45E Criteria of broker’s registration uk:uksi/2012/1916#regulation-45E

45F Provision of information uk:uksi/2012/1916#regulation-45F

45G Power to suspend or vary a broker’s registration or remove a broker from the register uk:uksi/2012/1916#regulation-45G

45H Procedure where licensing authority proposes to suspend or vary a broker’s registration or remove a broker from the register uk:uksi/2012/1916#regulation-45H

45I Suspension of a broker registration in cases of urgency uk:uksi/2012/1916#regulation-45I

45J Variation of a broker’s registration on the application of the broker uk:uksi/2012/1916#regulation-45J

45K Offences: breach of regulations and false information uk:uksi/2012/1916#regulation-45K

45L Penalties uk:uksi/2012/1916#regulation-45L

CHAPTER 4 Importation, manufacture and distribution of active substances · 10 provisions

45M Criteria for importation, manufacture or distribution of active substances uk:uksi/2012/1916#regulation-45M

45N Registration in relation to active substances uk:uksi/2012/1916#regulation-45N

45O Requirements for registration as an importer, manufacturer or distributor of an active substance uk:uksi/2012/1916#regulation-45O

45P Provision of information uk:uksi/2012/1916#regulation-45P

45Q Power to suspend or vary or remove an active substance registration uk:uksi/2012/1916#regulation-45Q

45R Procedure where licensing authority proposes to suspend or vary an active substance registration or remove a person from the active substance register uk:uksi/2012/1916#regulation-45R

45S Suspension of an active substance registration in cases of urgency uk:uksi/2012/1916#regulation-45S

45T Variation of an active substance registration on an application from the registered person uk:uksi/2012/1916#regulation-45T

45U Offences: breach of regulations and false information uk:uksi/2012/1916#regulation-45U

45V Penalties uk:uksi/2012/1916#regulation-45V

PART 4 Requirement for authorisation · 2 provisions

46 Requirement for authorisation uk:uksi/2012/1916#regulation-46

47 Breach of requirement uk:uksi/2012/1916#regulation-47

PART 5 Marketing authorisations · 95 provisions

48 Application of this Part uk:uksi/2012/1916#regulation-48

49 Application for grant of UK marketing authorisation or parallel import licence uk:uksi/2012/1916#regulation-49

50 Accompanying material uk:uksi/2012/1916#regulation-50

50A Requirement for certain applications to include results of paediatric investigation plan uk:uksi/2012/1916#regulation-50A

50B Agreement and modification of paediatric investigation plan uk:uksi/2012/1916#regulation-50B

50C Deferral of initiation or completion of measures in paediatric investigation plan uk:uksi/2012/1916#regulation-50C

50D Waiver of production of information in a paediatric investigation plan uk:uksi/2012/1916#regulation-50D

50E Application for paediatric use marketing authorisation uk:uksi/2012/1916#regulation-50E

50F Other applications including paediatric indications uk:uksi/2012/1916#regulation-50F

50G Applications relating to orphan medicinal products uk:uksi/2012/1916#regulation-50G

50H Applications relating to advanced therapy medicinal products uk:uksi/2012/1916#regulation-50H

50I Applications relating to conditional marketing authorisations ... uk:uksi/2012/1916#regulation-50I

50J Applications in relation to medicinal products containing or consisting of genetically modified organisms uk:uksi/2012/1916#regulation-50J

50K Applications relating to POC medicinal products uk:uksi/2012/1916#regulation-50K

51 Application for UKMA(NI) relating to generic medicinal products uk:uksi/2012/1916#regulation-51

51A Application for UKMA(GB) relating to generic medicinal products uk:uksi/2012/1916#regulation-51A

51B Application for UKMA(UK) relating to generic medicinal products uk:uksi/2012/1916#regulation-51B

52 Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc uk:uksi/2012/1916#regulation-52

52A Application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etc uk:uksi/2012/1916#regulation-52A

52B Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc. uk:uksi/2012/1916#regulation-52B

53 Application for UKMA(NI) relating to similar biological medicinal products uk:uksi/2012/1916#regulation-53

53A Application for UKMA(GB) relating to similar biological medicinal products uk:uksi/2012/1916#regulation-53A

53B Application for UKMA(UK) relating to similar biological medicinal products uk:uksi/2012/1916#regulation-53B

54 Applications relating to products in well-established medicinal use uk:uksi/2012/1916#regulation-54

55 Applications relating to new combinations of active substances uk:uksi/2012/1916#regulation-55

56 Applications containing information supplied in relation to another product with consent uk:uksi/2012/1916#regulation-56

57 Obligation to update information supplied in connection with application uk:uksi/2012/1916#regulation-57

57A Obligation to update information supplied in connection with parallel import licence application uk:uksi/2012/1916#regulation-57A

58 Consideration of application uk:uksi/2012/1916#regulation-58

58A Paediatric rewards uk:uksi/2012/1916#regulation-58A

58B Publication of information relating to paediatric marketing authorisations uk:uksi/2012/1916#regulation-58B

58C Consideration of applications relating to orphan medicinal products uk:uksi/2012/1916#regulation-58C

58D Orphan rewards uk:uksi/2012/1916#regulation-58D

58E Consideration of applications relating to combined advanced therapy medicinal products uk:uksi/2012/1916#regulation-58E

58F Consideration of applications relating to conditional marketing authorisations uk:uksi/2012/1916#regulation-58F

58G Consideration of applications in relation to medicinal products containing or consisting of genetically modified organisms uk:uksi/2012/1916#regulation-58G

59 Conditions of UK marketing authorisation or parallel import licence: general uk:uksi/2012/1916#regulation-59

60 Conditions of UK marketing authorisation or parallel import licence: exceptional circumstances uk:uksi/2012/1916#regulation-60

60A Condition as to the submitting of samples and other information to the appropriate authority uk:uksi/2012/1916#regulation-60A

60B Submitting of samples and other information: EU marketing authorisations uk:uksi/2012/1916#regulation-60B

61 Conditions of UK marketing authorisation: new obligations post-authorisation uk:uksi/2012/1916#regulation-61

62 Classification of UK marketing authorisation or parallel import licence uk:uksi/2012/1916#regulation-62

63 Frequency of periodic safety update reports uk:uksi/2012/1916#regulation-63

64 Duties of licensing authority in connection with determination uk:uksi/2012/1916#regulation-64

64A Obligation of licensing authority in case of change of classification uk:uksi/2012/1916#regulation-64A

65 Validity of UK marketing authorisation uk:uksi/2012/1916#regulation-65

65A Validity of parallel import licence uk:uksi/2012/1916#regulation-65A

65B Validity of conditional marketing authorisation uk:uksi/2012/1916#regulation-65B

65C Variation of a UKMA(GB) or a UKMA(UK)(Category 1) uk:uksi/2012/1916#regulation-65C

66 Application for renewal of authorisation uk:uksi/2012/1916#regulation-66

66A Application for renewal of a parallel import licence uk:uksi/2012/1916#regulation-66A

66B Renewal of conditional marketing authorisation uk:uksi/2012/1916#regulation-66B

67 Failure to place on the market etc uk:uksi/2012/1916#regulation-67

68 Revocation, variation and suspension of UK marketing authorisation or parallel import licence uk:uksi/2012/1916#regulation-68

69 Suspension of use etc of relevant medicinal product uk:uksi/2012/1916#regulation-69

70 Authorisations granted under Chapter 4 of Title III of the 2001 Directive uk:uksi/2012/1916#regulation-70

71 Withdrawal of medicinal product from the market uk:uksi/2012/1916#regulation-71

72 Sale etc of suspended medicinal product uk:uksi/2012/1916#regulation-72

73 Obligation to notify placing on the market etc uk:uksi/2012/1916#regulation-73

74 Obligation to take account of scientific and technical progress uk:uksi/2012/1916#regulation-74

74A Obligation to provide information relating to methods of manufacture and control: MM medicinal products uk:uksi/2012/1916#regulation-74A

74B Obligation to provide information relating to methods of manufacture and control: POC medicinal products uk:uksi/2012/1916#regulation-74B

75 Obligation to provide information relating to safety etc uk:uksi/2012/1916#regulation-75

76 Obligation in relation to product information uk:uksi/2012/1916#regulation-76

77 Record-keeping obligations uk:uksi/2012/1916#regulation-77

78 Obligation to ensure appropriate and continued supplies uk:uksi/2012/1916#regulation-78

78A Post authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions apply uk:uksi/2012/1916#regulation-78A

78B Post authorisation requirements in relation to UKMA(UK)(Category 1) for advanced therapy medicinal products uk:uksi/2012/1916#regulation-78B

79 Failure to provide information on marketing authorisations to EMA uk:uksi/2012/1916#regulation-79

80 Urgent safety restrictions uk:uksi/2012/1916#regulation-80

80A Urgent safety restrictions: parallel import licences uk:uksi/2012/1916#regulation-80A

A81 Application of regulations 89 to 94 uk:uksi/2012/1916#regulation-A81

81 Obligation to update information supplied in connection with EU application uk:uksi/2012/1916#regulation-81

82 EU marketing authorisations: failure to notify placing on market etc uk:uksi/2012/1916#regulation-82

83 EU marketing authorisations: failure to take account of technical and scientific progress uk:uksi/2012/1916#regulation-83

84 EU marketing authorisations: failure to provide information as to safety etc uk:uksi/2012/1916#regulation-84

85 EU marketing authorisations: failure to update product information uk:uksi/2012/1916#regulation-85

86 EU marketing authorisations: breach of pharmacovigilance condition etc uk:uksi/2012/1916#regulation-86

87 Offences in connection with risk management systems and traceability systems uk:uksi/2012/1916#regulation-87

88 Offence concerning data for advanced therapy medicinal products uk:uksi/2012/1916#regulation-88

89 Offences in connection with withdrawal of product from the market uk:uksi/2012/1916#regulation-89

90 Failure to place on the market taking account of paediatric indication uk:uksi/2012/1916#regulation-90

91 Failure to notify results of third country clinical trials uk:uksi/2012/1916#regulation-91

92 Failure of sponsor of UK paediatric clinical trial to notify results of trial uk:uksi/2012/1916#regulation-92

93 Failure to notify results of paediatric study uk:uksi/2012/1916#regulation-93

94 Failure to submit report to EMA uk:uksi/2012/1916#regulation-94

94A Offences relating to Commission Regulation 2016/161 uk:uksi/2012/1916#regulation-94A

95 Offences in connection with application uk:uksi/2012/1916#regulation-95

95A Offences in connection with parallel import licence application uk:uksi/2012/1916#regulation-95A

96 Provision of false or misleading information uk:uksi/2012/1916#regulation-96

97 Breach of pharmacovigilance condition uk:uksi/2012/1916#regulation-97

98 General offence of breach of provision of this Part uk:uksi/2012/1916#regulation-98

99 Penalties uk:uksi/2012/1916#regulation-99

100 Persons liable uk:uksi/2012/1916#regulation-100

101 Defences uk:uksi/2012/1916#regulation-101

PART 6 Certification of homoeopathic medicinal products · 23 provisions

102 Application of Part uk:uksi/2012/1916#regulation-102

103 Application for certificate of registration uk:uksi/2012/1916#regulation-103

104 Consideration of application uk:uksi/2012/1916#regulation-104

105 Conditions of certificate of registration uk:uksi/2012/1916#regulation-105

106 Classification of certificate of registration uk:uksi/2012/1916#regulation-106

107 Validity of certificate of registration uk:uksi/2012/1916#regulation-107

108 Application for renewal of certificate uk:uksi/2012/1916#regulation-108

109 Failure to place on the market etc uk:uksi/2012/1916#regulation-109

110 Revocation, variation and suspension of certificate of registration uk:uksi/2012/1916#regulation-110

111 Certificates granted under Chapter 4 of Title III of the 2001 Directive uk:uksi/2012/1916#regulation-111

112 Withdrawal of homoeopathic medicinal product from the market uk:uksi/2012/1916#regulation-112

113 Obligation to notify placing on the market etc uk:uksi/2012/1916#regulation-113

114 Obligation to take account of scientific and technical progress uk:uksi/2012/1916#regulation-114

115 Obligation to provide information relating to safety etc uk:uksi/2012/1916#regulation-115

116 Obligation in relation to product information uk:uksi/2012/1916#regulation-116

117 Record-keeping obligation uk:uksi/2012/1916#regulation-117

118 Obligation to ensure appropriate and continued supplies uk:uksi/2012/1916#regulation-118

119 Offences in connection with applications uk:uksi/2012/1916#regulation-119

120 Provision of false or misleading information uk:uksi/2012/1916#regulation-120

121 General offence of breach of provision of this Part uk:uksi/2012/1916#regulation-121

122 Penalties uk:uksi/2012/1916#regulation-122

123 Persons liable uk:uksi/2012/1916#regulation-123

124 Defences uk:uksi/2012/1916#regulation-124

PART 7 Traditional herbal registrations · 37 provisions

124A Interpretation of this Part uk:uksi/2012/1916#regulation-124A

125 Traditional herbal medicinal products uk:uksi/2012/1916#regulation-125

125A List of approved countries for traditional use of a herbal medicinal product uk:uksi/2012/1916#regulation-125A

126 Addition of vitamins or minerals uk:uksi/2012/1916#regulation-126

126A Licensing authority list as to herbal substances, preparations and combinations for use in traditional herbal medicinal products uk:uksi/2012/1916#regulation-126A

127 Application for grant of traditional herbal registration uk:uksi/2012/1916#regulation-127

128 Accompanying material uk:uksi/2012/1916#regulation-128

129 Obligation to update information supplied in connection with application uk:uksi/2012/1916#regulation-129

130 Consideration of application uk:uksi/2012/1916#regulation-130

130A Procedure where less than 15 years use of traditional herbal medicinal product uk:uksi/2012/1916#regulation-130A

131 Classification of traditional herbal registration uk:uksi/2012/1916#regulation-131

132 Validity of traditional herbal registration uk:uksi/2012/1916#regulation-132

133 Application for renewal of registration uk:uksi/2012/1916#regulation-133

134 Failure to place on the market etc uk:uksi/2012/1916#regulation-134

135 Revocation, variation and suspension of traditional herbal registration uk:uksi/2012/1916#regulation-135

136 Revocation by licensing authority: further provisions uk:uksi/2012/1916#regulation-136

137 Procedures for revocation, variation or suspension uk:uksi/2012/1916#regulation-137

138 Suspension of use etc of traditional herbal medicinal product uk:uksi/2012/1916#regulation-138

139 Registrations granted under Chapter 4 of Title III of the 2001 Directive uk:uksi/2012/1916#regulation-139

140 Withdrawal of traditional herbal medicinal product from the market uk:uksi/2012/1916#regulation-140

141 Sale etc of suspended traditional herbal medicinal product uk:uksi/2012/1916#regulation-141

142 Obligation to notify placing on the market etc uk:uksi/2012/1916#regulation-142

143 Obligation to take account of scientific and technical progress uk:uksi/2012/1916#regulation-143

143A Establishment of herbal monographs uk:uksi/2012/1916#regulation-143A

144 Obligation following new herbal monograph uk:uksi/2012/1916#regulation-144

145 Obligation to provide information relating to safety etc uk:uksi/2012/1916#regulation-145

146 Obligation in relation to product information uk:uksi/2012/1916#regulation-146

147 Record-keeping obligations uk:uksi/2012/1916#regulation-147

148 Obligation to ensure appropriate and continued supplies uk:uksi/2012/1916#regulation-148

148A Urgent safety restrictions uk:uksi/2012/1916#regulation-148A

149 Urgent safety restrictions uk:uksi/2012/1916#regulation-149

150 Offences in connection with applications uk:uksi/2012/1916#regulation-150

151 Provision of false or misleading information uk:uksi/2012/1916#regulation-151

152 General offence of breach of provision of this Part uk:uksi/2012/1916#regulation-152

153 Penalties uk:uksi/2012/1916#regulation-153

154 Persons liable uk:uksi/2012/1916#regulation-154

155 Defences uk:uksi/2012/1916#regulation-155

PART 8 Article 126a authorisations · 3 provisions

156 Article 126a authorisations uk:uksi/2012/1916#regulation-156

157 Requests from EU member States uk:uksi/2012/1916#regulation-157

158 Application of these Regulations uk:uksi/2012/1916#regulation-158

PART 9 Borderline products · 8 provisions

159 Provisional determination uk:uksi/2012/1916#regulation-159

160 Challenge to provisional determination uk:uksi/2012/1916#regulation-160

161 Written representations procedure uk:uksi/2012/1916#regulation-161

162 Oral representations procedure uk:uksi/2012/1916#regulation-162

163 Final determination without representations uk:uksi/2012/1916#regulation-163

164 Effect of final determination uk:uksi/2012/1916#regulation-164

165 Determination in other cases uk:uksi/2012/1916#regulation-165

166 Offences relating to borderline products uk:uksi/2012/1916#regulation-166

PART 10 Exceptions to requirement for marketing authorisation etc · 21 provisions

167 Supply to fulfil special patient needs uk:uksi/2012/1916#regulation-167

167A NIMAR supply to Northern Ireland uk:uksi/2012/1916#regulation-167A

167B List of NIMAR products uk:uksi/2012/1916#regulation-167B

167C Early Access to Medicines Scheme: establishment and licensing authority functions uk:uksi/2012/1916#regulation-167C

167D EAMS scientific opinions ceasing to have effect uk:uksi/2012/1916#regulation-167D

167E EAMS medicinal products: manufacture, assembly, importation, distribution and supply uk:uksi/2012/1916#regulation-167E

167F Advertising of EAMS medicinal products uk:uksi/2012/1916#regulation-167F

167G EAMS medicinal products: pharmacovigilance uk:uksi/2012/1916#regulation-167G

167H Early Access to Medicines Scheme: data collection uk:uksi/2012/1916#regulation-167H

168 Use of non-prescription medicines in the course of a business uk:uksi/2012/1916#regulation-168

169 Mixing of general sale medicinal products uk:uksi/2012/1916#regulation-169

170 Record-keeping requirements uk:uksi/2012/1916#regulation-170

170A MM medicinal products: pharmacovigilance requirements uk:uksi/2012/1916#regulation-170A

170B POC medicinal products: pharmacovigilance requirements uk:uksi/2012/1916#regulation-170B

171 Exempt advanced therapy medicinal products uk:uksi/2012/1916#regulation-171

172 Parallel import licences uk:uksi/2012/1916#regulation-172

173 Exemption for certain radiopharmaceuticals uk:uksi/2012/1916#regulation-173

174 Supply in response to spread of pathogenic agents etc uk:uksi/2012/1916#regulation-174

174A Conditions of temporary authorisations under regulation 174 uk:uksi/2012/1916#regulation-174A

175 Offences relating to exceptions uk:uksi/2012/1916#regulation-175

176 Penalties and supplementary provision about offences uk:uksi/2012/1916#regulation-176

PART 11 Pharmacovigilance · 43 provisions

177 Application of this Part and interpretation uk:uksi/2012/1916#regulation-177

178 General obligations of the licensing authority uk:uksi/2012/1916#regulation-178

179 Obligation on licensing authority to operate pharmacovigilance system uk:uksi/2012/1916#regulation-179

180 Obligation on licensing authority to audit pharmacovigilance system uk:uksi/2012/1916#regulation-180

181 Delegation of obligations under this Part uk:uksi/2012/1916#regulation-181

182 Obligation on holder to operate pharmacovigilance system uk:uksi/2012/1916#regulation-182

183 Exception to obligation to operate risk management system uk:uksi/2012/1916#regulation-183

184 Obligation on holder to audit pharmacovigilance system uk:uksi/2012/1916#regulation-184

185 Recording obligations on the licensing authority uk:uksi/2012/1916#regulation-185

186 Reporting obligations on the licensing authority uk:uksi/2012/1916#regulation-186

186A uk:uksi/2012/1916#regulation-186A

187 Recording obligations on holders uk:uksi/2012/1916#regulation-187

188 Reporting obligations on holders uk:uksi/2012/1916#regulation-188

189 Signal detection: licensing authority obligations uk:uksi/2012/1916#regulation-189

190 Signal detection: holder obligation uk:uksi/2012/1916#regulation-190

191 Obligation on holder to submit periodic safety update reports: general requirements uk:uksi/2012/1916#regulation-191

191A Obligation on holder of a parallel import licence to submit periodic safety update reports uk:uksi/2012/1916#regulation-191A

192 Obligation on holder to submit periodic safety update reports: derogation from general requirements uk:uksi/2012/1916#regulation-192

193 Harmonisation of PSUR frequency or date of submission uk:uksi/2012/1916#regulation-193

194 Responding to a single assessment of PSUR under Article 107e of the 2001 Directive uk:uksi/2012/1916#regulation-194

195 Obligation on licensing authority to assess PSURs ... uk:uksi/2012/1916#regulation-195

196 Urgent action uk:uksi/2012/1916#regulation-196

196A Major safety review by the licensing authority uk:uksi/2012/1916#regulation-196A

197 EU urgent action procedure uk:uksi/2012/1916#regulation-197

198 Post-authorisation safety studies: general provisions uk:uksi/2012/1916#regulation-198

199 Submission of draft study protocols for required studies uk:uksi/2012/1916#regulation-199

200 Amendment to study protocols for required studies uk:uksi/2012/1916#regulation-200

201 Submission and evaluation of final study reports for required studies uk:uksi/2012/1916#regulation-201

202 Follow-up of final study reports uk:uksi/2012/1916#regulation-202

202A Licensing authority power in relation to medicinal products subject to additional monitoring uk:uksi/2012/1916#regulation-202A

203 Obligations on licensing authority in relation to national medicines web-portal uk:uksi/2012/1916#regulation-203

204 Obligation on licensing authority in relation to public announcements uk:uksi/2012/1916#regulation-204

205 Obligations on holders in relation to public announcements uk:uksi/2012/1916#regulation-205

205A Further obligations in respect of pharmacovigilance activities uk:uksi/2012/1916#regulation-205A

205B Guidance in respect of good pharmacovigilance practice and post authorisation efficacy studies uk:uksi/2012/1916#regulation-205B

206 Infringement notices uk:uksi/2012/1916#regulation-206

207 Offences uk:uksi/2012/1916#regulation-207

208 False and misleading information uk:uksi/2012/1916#regulation-208

209 Penalties uk:uksi/2012/1916#regulation-209

210 Offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004 uk:uksi/2012/1916#regulation-210

210A Offences in relation to pharmacovigilance obligations under the Implementing Regulation and Schedule 12A uk:uksi/2012/1916#regulation-210A

211 Persons liable uk:uksi/2012/1916#regulation-211

212 Transitional arrangements uk:uksi/2012/1916#regulation-212

CHAPTER 1 Interpretation · 1 provisions

213 Interpretation uk:uksi/2012/1916#regulation-213

CHAPTER 2 Sale and supply of medicines · 18 provisions

214 Sale or supply of prescription only medicines uk:uksi/2012/1916#regulation-214

215 Prescribing and administration by supplementary prescribers uk:uksi/2012/1916#regulation-215

216 Exceptions to regulation 215 uk:uksi/2012/1916#regulation-216

217 Requirements for prescriptions: general uk:uksi/2012/1916#regulation-217

217A Requirements for prescriptions to be dispensed in an EEA state ... uk:uksi/2012/1916#regulation-217A

217B Original pack dispensing uk:uksi/2012/1916#regulation-217B

217BA Original pack dispensing: Northern Ireland uk:uksi/2012/1916#regulation-217BA

217C Original pack dispensing: medicinal products containing a relevant substance uk:uksi/2012/1916#regulation-217C

217CA Original pack dispensing: medicinal products containing a relevant substance: Northern Ireland uk:uksi/2012/1916#regulation-217CA

218 Requirements for prescriptions: approved country health professional uk:uksi/2012/1916#regulation-218

219 Electronic prescriptions uk:uksi/2012/1916#regulation-219

219A Electronic Prescriptions: approved country health professionals uk:uksi/2012/1916#regulation-219A

220 Sale or supply of medicinal products not subject to general sale uk:uksi/2012/1916#regulation-220

220B Sale or supply of items dispensed by a pharmacist who is absent or treated as absent uk:uksi/2012/1916#regulation-220B

221 Sale or supply of medicinal products subject to general sale uk:uksi/2012/1916#regulation-221

222 Sale of medicinal products from automatic machines uk:uksi/2012/1916#regulation-222

222A Assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses uk:uksi/2012/1916#regulation-222A

222B Hub and spoke arrangements: sharing of data between different businesses uk:uksi/2012/1916#regulation-222B

CHAPTER 3 Exemptions · 30 provisions

223 Exemptions for doctors and dentists etc uk:uksi/2012/1916#regulation-223

224 Emergency sale etc by pharmacist: prescriber unable to provide prescription uk:uksi/2012/1916#regulation-224

225 Emergency sale etc by pharmacist: at patient's request uk:uksi/2012/1916#regulation-225

226 Emergency sale etc by pharmacist: pandemic diseases uk:uksi/2012/1916#regulation-226

226A Sale etc by a pharmacist in accordance with a serious shortage protocol uk:uksi/2012/1916#regulation-226A

227 Exemption for sale or supply in hospitals uk:uksi/2012/1916#regulation-227

228 Exemptions relating to prescriptions given by certain health professionals uk:uksi/2012/1916#regulation-228

229 Exemption for supply by national health service bodies and local authorities uk:uksi/2012/1916#regulation-229

230 Exemption for supply etc under a PGD to assist doctors or dentists uk:uksi/2012/1916#regulation-230

231 Exemption for supply etc under a PGD by independent hospitals etc uk:uksi/2012/1916#regulation-231

232 Exemption for supply etc under a PGD by dental practices and clinics: England and Wales uk:uksi/2012/1916#regulation-232

233 Exemption for supply etc under a PGD by person conducting a retail pharmacy business uk:uksi/2012/1916#regulation-233

234 Exemption for supply etc of products under a PGD to assist the police etc uk:uksi/2012/1916#regulation-234

235 Exemption for sale, supply or administration by certain persons uk:uksi/2012/1916#regulation-235

235A Exemption for supply or administration of certain medicines used for vaccination uk:uksi/2012/1916#regulation-235A

236 Products consisting of or containing aloxiprin, aspirin or paracetamol uk:uksi/2012/1916#regulation-236

237 Products consisting of or containing pseudoephedrine salts or ephedrine base or salts uk:uksi/2012/1916#regulation-237

237A Appropriate suppliers of naloxone products uk:uksi/2012/1916#regulation-237A

238 Administration of certain medicines in an emergency uk:uksi/2012/1916#regulation-238

239 Administration of smallpox vaccine uk:uksi/2012/1916#regulation-239

240 Radioactive medicinal products uk:uksi/2012/1916#regulation-240

241 Exemptions in respect of certain herbal remedies uk:uksi/2012/1916#regulation-241

242 Exemption for medicinal products at high dilution uk:uksi/2012/1916#regulation-242

243 Exemption for certain homoeopathic medicinal products uk:uksi/2012/1916#regulation-243

244 Exemption in cases involving another's default uk:uksi/2012/1916#regulation-244

245 Exemption in case of forged prescription uk:uksi/2012/1916#regulation-245

246 Exemption where requirements for prescriptions not met uk:uksi/2012/1916#regulation-246

247 Exemption for supply in the event or anticipation of pandemic disease uk:uksi/2012/1916#regulation-247

247A Protocols relating to coronavirus and influenza vaccinations and immunisations uk:uksi/2012/1916#regulation-247A

248 Exemption for certain collection and delivery arrangements uk:uksi/2012/1916#regulation-248

CHAPTER 4 Miscellaneous provisions, offences and disqualification · 11 provisions

249 Restrictions on persons to be supplied with medicinal products uk:uksi/2012/1916#regulation-249

250 Exceptions to regulation 249 uk:uksi/2012/1916#regulation-250

251 Compliance with standards specified in certain publications uk:uksi/2012/1916#regulation-251

252 Compliance with standards specified in certain publications: supplementary uk:uksi/2012/1916#regulation-252

253 Pharmacy records uk:uksi/2012/1916#regulation-253

254 Prohibitions concerning traceability of treatment with advanced therapy medicinal products uk:uksi/2012/1916#regulation-254

255 Offences relating to dealings with medicinal products uk:uksi/2012/1916#regulation-255

255A Enforcement notices relating to Commission Regulation 2016/161: persons authorised to supply medicinal products to the public uk:uksi/2012/1916#regulation-255A

255B Exception to Article 25 of Commission Regulation 2016/161: health care institutions uk:uksi/2012/1916#regulation-255B

255C Offences relating to Commission Regulation 2016/161: management of the repository system uk:uksi/2012/1916#regulation-255C

256 Disqualification on conviction uk:uksi/2012/1916#regulation-256

PART12A Sale of medicines to the public at a distance · 15 provisions

256ZA Application of Part uk:uksi/2012/1916#regulation-256ZA

256A Interpretation uk:uksi/2012/1916#regulation-256A

256B Person who may sell medicinal products by information society services uk:uksi/2012/1916#regulation-256B

256C Notification requirements for sellers of medicinal products at a distance uk:uksi/2012/1916#regulation-256C

256D Procedure for listing persons who may supply medicinal products at a distance uk:uksi/2012/1916#regulation-256D

256E Removal of a person’s entry from the list uk:uksi/2012/1916#regulation-256E

256F Provision of information to the licensing authority uk:uksi/2012/1916#regulation-256F

256G Grant or refusal to list a person uk:uksi/2012/1916#regulation-256G

256H Conditions to be met by a person entered on the list uk:uksi/2012/1916#regulation-256H

256I Power to suspend, vary or remove a person’s entry on the list uk:uksi/2012/1916#regulation-256I

256J Procedure where the licensing authority proposes to suspend, vary or remove a person’s entry on the list uk:uksi/2012/1916#regulation-256J

256K Suspension of a person’s entry on the list in cases of urgency uk:uksi/2012/1916#regulation-256K

256L Variation of a person’s entry on the list on the application of that person uk:uksi/2012/1916#regulation-256L

256M Offences: breach of regulations and false information uk:uksi/2012/1916#regulation-256M

256N Penalties uk:uksi/2012/1916#regulation-256N

CHAPTER 1 · 25 provisions

257 Packaging requirements: general uk:uksi/2012/1916#regulation-257

257AA Packaging requirements: variation in accordance with regulation 68(11I) uk:uksi/2012/1916#regulation-257AA

257AB Transitional arrangements uk:uksi/2012/1916#regulation-257AB

257A Packaging Requirements: medicinal products required to bear safety features uk:uksi/2012/1916#regulation-257A

257B Transitional Arrangements uk:uksi/2012/1916#regulation-257B

257C Packaging requirements: advanced therapy medicinal products uk:uksi/2012/1916#regulation-257C

257CA Packaging requirements: POC medicinal products uk:uksi/2012/1916#regulation-257CA

257D Guidance as to packaging and package leaflets uk:uksi/2012/1916#regulation-257D

257E Regulation-making power as to certain forms of labelling uk:uksi/2012/1916#regulation-257E

258 Packaging requirements: specific provisions uk:uksi/2012/1916#regulation-258

259 Packaging requirements: information for blind and partially sighted patients uk:uksi/2012/1916#regulation-259

260 Package leaflets uk:uksi/2012/1916#regulation-260

261 Use of pictures and symbols etc uk:uksi/2012/1916#regulation-261

262 Labelling requirements for radionuclides uk:uksi/2012/1916#regulation-262

263 Leaflets relating to radionuclides uk:uksi/2012/1916#regulation-263

264 Homoeopathic medicines uk:uksi/2012/1916#regulation-264

265 Additional requirements for traditional herbal medicinal products uk:uksi/2012/1916#regulation-265

266 Language requirements etc uk:uksi/2012/1916#regulation-266

267 Submission of mock-ups of packaging and leaflets to licensing authority uk:uksi/2012/1916#regulation-267

268 Offence relating to packaging and package leaflets in Great Britain: holder of authorisation etc uk:uksi/2012/1916#regulation-268

268A Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc uk:uksi/2012/1916#regulation-268A

269 Offences relating to packaging and package leaflets in Great Britain: other persons uk:uksi/2012/1916#regulation-269

269A Offences relating to packaging and package leaflets in Northern Ireland: other persons uk:uksi/2012/1916#regulation-269A

270 Non-compliance with requirements of this Part uk:uksi/2012/1916#regulation-270

271 Offences: penalties uk:uksi/2012/1916#regulation-271

CHAPTER 2 · 5 provisions

272 Interpretation uk:uksi/2012/1916#regulation-272

273 Child resistant containers for regulated medicinal products uk:uksi/2012/1916#regulation-273

274 Exemptions from regulation 273 uk:uksi/2012/1916#regulation-274

275 Colouring of aspirin and paracetamol products for children uk:uksi/2012/1916#regulation-275

276 Offences uk:uksi/2012/1916#regulation-276

CHAPTER 1 General · 2 provisions

277 Interpretation uk:uksi/2012/1916#regulation-277

278 Functions of the Ministers uk:uksi/2012/1916#regulation-278

CHAPTER 2 Requirements relating to advertising · 27 provisions

279 Products without a marketing authorisation etc uk:uksi/2012/1916#regulation-279

280 General principles uk:uksi/2012/1916#regulation-280

281 Duties of authorisation holders and registration holders uk:uksi/2012/1916#regulation-281

282 Application of regulations 283 to 292 uk:uksi/2012/1916#regulation-282

283 Products for the purpose of inducing abortions uk:uksi/2012/1916#regulation-283

284 Prescription only medicines uk:uksi/2012/1916#regulation-284

284A Medicines with differing classification status in Great Britain and Northern Ireland uk:uksi/2012/1916#regulation-284A

285 Narcotic and psychotropic substances uk:uksi/2012/1916#regulation-285

286 Material relating to diagnosis uk:uksi/2012/1916#regulation-286

287 Material about effects of medicinal product uk:uksi/2012/1916#regulation-287

288 Material about status of medicinal product uk:uksi/2012/1916#regulation-288

289 Recommendations by scientists etc uk:uksi/2012/1916#regulation-289

290 Advertisements directed at children uk:uksi/2012/1916#regulation-290

291 Form and content of advertisement uk:uksi/2012/1916#regulation-291

291A Campaigns relating to the suspected or confirmed spread of pathogenic agents etc. uk:uksi/2012/1916#regulation-291A

292 Exception for approved vaccination campaigns uk:uksi/2012/1916#regulation-292

293 Prohibition of supply to the public for promotional purposes uk:uksi/2012/1916#regulation-293

294 General requirements uk:uksi/2012/1916#regulation-294

295 Abbreviated advertisements uk:uksi/2012/1916#regulation-295

296 Exception for advertisements intended as a reminder uk:uksi/2012/1916#regulation-296

297 Written material accompanying promotions uk:uksi/2012/1916#regulation-297

298 Free samples for persons qualified to prescribe or supply medicinal products uk:uksi/2012/1916#regulation-298

299 Medical sales representatives uk:uksi/2012/1916#regulation-299

300 Inducements and hospitality uk:uksi/2012/1916#regulation-300

301 Advertisements for registered homoeopathic medicinal products uk:uksi/2012/1916#regulation-301

302 Advertisements for traditional herbal medicinal products uk:uksi/2012/1916#regulation-302

303 Offences uk:uksi/2012/1916#regulation-303

CHAPTER 3 Monitoring of Advertising · 13 provisions

304 Requirement to provide copy advertisement uk:uksi/2012/1916#regulation-304

305 Invitation to make representations about compatibility uk:uksi/2012/1916#regulation-305

306 Decision about compatibility uk:uksi/2012/1916#regulation-306

307 Corrective statement uk:uksi/2012/1916#regulation-307

308 Offences uk:uksi/2012/1916#regulation-308

309 Complaints to Ministers: duty to consider uk:uksi/2012/1916#regulation-309

310 Complaints to Ministers: power to refer uk:uksi/2012/1916#regulation-310

311 Application for injunction uk:uksi/2012/1916#regulation-311

312 Application for injunction: accuracy of factual claim uk:uksi/2012/1916#regulation-312

313 Grant of injunction: publication of decision and corrective statement uk:uksi/2012/1916#regulation-313

314 Complaints to OFCOM uk:uksi/2012/1916#regulation-314

315 Public interest etc uk:uksi/2012/1916#regulation-315

316 Civil proceedings uk:uksi/2012/1916#regulation-316

PART 15 British Pharmacopoeia · 5 provisions

317 British Pharmacopoeia and compendia uk:uksi/2012/1916#regulation-317

318 Lists of names uk:uksi/2012/1916#regulation-318

319 Other documents uk:uksi/2012/1916#regulation-319

320 Supplementary provisions uk:uksi/2012/1916#regulation-320

321 Specified publications uk:uksi/2012/1916#regulation-321

PART 16 Enforcement · 14 provisions

322 Validity of decisions and proceedings uk:uksi/2012/1916#regulation-322

323 Enforcement in England, Wales and Scotland uk:uksi/2012/1916#regulation-323

324 Enforcement in Northern Ireland uk:uksi/2012/1916#regulation-324

325 Rights of entry uk:uksi/2012/1916#regulation-325

326 Application for warrant uk:uksi/2012/1916#regulation-326

327 Powers of inspection, sampling and seizure uk:uksi/2012/1916#regulation-327

328 Regulation 327: supplementary uk:uksi/2012/1916#regulation-328

329 Application of sampling procedure to substance or article seized under this Part uk:uksi/2012/1916#regulation-329

330 Analysis of samples: other cases uk:uksi/2012/1916#regulation-330

331 Findings and reports of inspections uk:uksi/2012/1916#regulation-331

331A Guidelines on inspections uk:uksi/2012/1916#regulation-331A

332 Restrictions on disclosure of information uk:uksi/2012/1916#regulation-332

333 Protection for inspectors uk:uksi/2012/1916#regulation-333

334 Supplementary provisions and offences uk:uksi/2012/1916#regulation-334

PART 17 Miscellaneous and general · 20 provisions

335 Contravention due to fault of another person uk:uksi/2012/1916#regulation-335

336 Warranty as defence uk:uksi/2012/1916#regulation-336

337 Offences in relation to warranties and certificates uk:uksi/2012/1916#regulation-337

338 Offences by bodies corporate and partnerships uk:uksi/2012/1916#regulation-338

339 Prosecutions uk:uksi/2012/1916#regulation-339

340 Presumptions uk:uksi/2012/1916#regulation-340

341 Decisions under these Regulations uk:uksi/2012/1916#regulation-341

342 Time limits for provision of information etc uk:uksi/2012/1916#regulation-342

343 Service of documents uk:uksi/2012/1916#regulation-343

344 Payment of expenses by Ministers uk:uksi/2012/1916#regulation-344

344A Modifications to deal with serious shortages uk:uksi/2012/1916#regulation-344A

344B Regulation making powers uk:uksi/2012/1916#regulation-344B

345 Immunity from civil liability uk:uksi/2012/1916#regulation-345

345A Obligation on licensing authority to maintain list of medicinal products to which derogations have applied uk:uksi/2012/1916#regulation-345A

346 Review uk:uksi/2012/1916#regulation-346

347 Transitional provisions and savings uk:uksi/2012/1916#regulation-347

347A Transitional provision in relation to EU exit uk:uksi/2012/1916#regulation-347A

347B Transitional provision relating to the Windsor Framework uk:uksi/2012/1916#regulation-347B

348 Amendments to existing law uk:uksi/2012/1916#regulation-348

349 Repeals and revocations uk:uksi/2012/1916#regulation-349

PART 1 Descriptions of certain medicinal products to be available only on prescription · 2 provisions

1 uk:uksi/2012/1916#schedule-1-paragraph-1

2 uk:uksi/2012/1916#schedule-1-paragraph-2

PART 2 Descriptions of certain medicinal products to be available only from a pharmacy · 3 provisions

3 uk:uksi/2012/1916#schedule-1-paragraph-3

4 uk:uksi/2012/1916#schedule-1-paragraph-4

5 uk:uksi/2012/1916#schedule-1-paragraph-5

Terms of appointment · 4 provisions

1 uk:uksi/2012/1916#schedule-2-paragraph-1

2 uk:uksi/2012/1916#schedule-2-paragraph-2

3 uk:uksi/2012/1916#schedule-2-paragraph-3

4 uk:uksi/2012/1916#schedule-2-paragraph-4

Facilities and proceedings · 3 provisions

5 uk:uksi/2012/1916#schedule-2-paragraph-5

6 uk:uksi/2012/1916#schedule-2-paragraph-6

7 uk:uksi/2012/1916#schedule-2-paragraph-7

Payment and expenses · 4 provisions

8 uk:uksi/2012/1916#schedule-2-paragraph-8

9 uk:uksi/2012/1916#schedule-2-paragraph-9

10 uk:uksi/2012/1916#schedule-2-paragraph-10

11 uk:uksi/2012/1916#schedule-2-paragraph-11

Status · 1 provisions

12 uk:uksi/2012/1916#schedule-2-paragraph-12

Manufacturer's licences · 1 provisions

1 uk:uksi/2012/1916#schedule-3-paragraph-1

Manufacturer’s licences (MM) · 1 provisions

1A uk:uksi/2012/1916#schedule-3-paragraph-1A

Manufacturer’s licence (POC) · 1 provisions

1B uk:uksi/2012/1916#schedule-3-paragraph-1B

Manufacturers' licence relating to import · 1 provisions

2 uk:uksi/2012/1916#schedule-3-paragraph-2

Wholesale dealer's licences · 1 provisions

3 uk:uksi/2012/1916#schedule-3-paragraph-3

All licences · 1 provisions

4 uk:uksi/2012/1916#schedule-3-paragraph-4

PART 1 Manufacturer's licence relating to manufacture and assembly · 16 provisions

1 uk:uksi/2012/1916#schedule-4-paragraph-1

2 uk:uksi/2012/1916#schedule-4-paragraph-2

3 uk:uksi/2012/1916#schedule-4-paragraph-3

4 uk:uksi/2012/1916#schedule-4-paragraph-4

5 uk:uksi/2012/1916#schedule-4-paragraph-5

6 uk:uksi/2012/1916#schedule-4-paragraph-6

7 uk:uksi/2012/1916#schedule-4-paragraph-7

8 uk:uksi/2012/1916#schedule-4-paragraph-8

9 uk:uksi/2012/1916#schedule-4-paragraph-9

10 uk:uksi/2012/1916#schedule-4-paragraph-10

11 uk:uksi/2012/1916#schedule-4-paragraph-11

12 uk:uksi/2012/1916#schedule-4-paragraph-12

13 uk:uksi/2012/1916#schedule-4-paragraph-13

14 uk:uksi/2012/1916#schedule-4-paragraph-14

14A uk:uksi/2012/1916#schedule-4-paragraph-14A

14B uk:uksi/2012/1916#schedule-4-paragraph-14B

Part 1A Manufacturer’s licence (MM) · 9 provisions

14C uk:uksi/2012/1916#schedule-4-paragraph-14C

14D uk:uksi/2012/1916#schedule-4-paragraph-14D

14E uk:uksi/2012/1916#schedule-4-paragraph-14E

14F uk:uksi/2012/1916#schedule-4-paragraph-14F

14G uk:uksi/2012/1916#schedule-4-paragraph-14G

14H uk:uksi/2012/1916#schedule-4-paragraph-14H

14I uk:uksi/2012/1916#schedule-4-paragraph-14I

14J uk:uksi/2012/1916#schedule-4-paragraph-14J

14K uk:uksi/2012/1916#schedule-4-paragraph-14K

Part 1B Manufacturer’s Licence (POC) · 9 provisions

14L uk:uksi/2012/1916#schedule-4-paragraph-14L

14M uk:uksi/2012/1916#schedule-4-paragraph-14M

14N uk:uksi/2012/1916#schedule-4-paragraph-14N

14O uk:uksi/2012/1916#schedule-4-paragraph-14O

14P uk:uksi/2012/1916#schedule-4-paragraph-14P

14Q uk:uksi/2012/1916#schedule-4-paragraph-14Q

14R uk:uksi/2012/1916#schedule-4-paragraph-14R

14S uk:uksi/2012/1916#schedule-4-paragraph-14S

14T uk:uksi/2012/1916#schedule-4-paragraph-14T

PART 2 Manufacturer's licence relating to the import of medicinal products from a state other than an EEA State / Country other than an Approved Country for Import · 13 provisions

15 uk:uksi/2012/1916#schedule-4-paragraph-15

15A uk:uksi/2012/1916#schedule-4-paragraph-15A

16 uk:uksi/2012/1916#schedule-4-paragraph-16

17 uk:uksi/2012/1916#schedule-4-paragraph-17

18 uk:uksi/2012/1916#schedule-4-paragraph-18

19 uk:uksi/2012/1916#schedule-4-paragraph-19

20 uk:uksi/2012/1916#schedule-4-paragraph-20

21 uk:uksi/2012/1916#schedule-4-paragraph-21

22 uk:uksi/2012/1916#schedule-4-paragraph-22

23 uk:uksi/2012/1916#schedule-4-paragraph-23

23ZA uk:uksi/2012/1916#schedule-4-paragraph-23ZA

23A uk:uksi/2012/1916#schedule-4-paragraph-23A

23B uk:uksi/2012/1916#schedule-4-paragraph-23B

PART 3 Manufacturer's licence relating to exempt advanced therapy medicinal products · 4 provisions

24 uk:uksi/2012/1916#schedule-4-paragraph-24

25 uk:uksi/2012/1916#schedule-4-paragraph-25

26 uk:uksi/2012/1916#schedule-4-paragraph-26

27 uk:uksi/2012/1916#schedule-4-paragraph-27

PART 4 Wholesale dealer's licence · 19 provisions

28 uk:uksi/2012/1916#schedule-4-paragraph-28

29 uk:uksi/2012/1916#schedule-4-paragraph-29

30 uk:uksi/2012/1916#schedule-4-paragraph-30

31 uk:uksi/2012/1916#schedule-4-paragraph-31

32 uk:uksi/2012/1916#schedule-4-paragraph-32

33 uk:uksi/2012/1916#schedule-4-paragraph-33

33A uk:uksi/2012/1916#schedule-4-paragraph-33A

34 uk:uksi/2012/1916#schedule-4-paragraph-34

35 uk:uksi/2012/1916#schedule-4-paragraph-35

36 uk:uksi/2012/1916#schedule-4-paragraph-36

37 uk:uksi/2012/1916#schedule-4-paragraph-37

38 uk:uksi/2012/1916#schedule-4-paragraph-38

39 uk:uksi/2012/1916#schedule-4-paragraph-39

40 uk:uksi/2012/1916#schedule-4-paragraph-40

41 uk:uksi/2012/1916#schedule-4-paragraph-41

41A uk:uksi/2012/1916#schedule-4-paragraph-41A

42 uk:uksi/2012/1916#schedule-4-paragraph-42

43 uk:uksi/2012/1916#schedule-4-paragraph-43

44 uk:uksi/2012/1916#schedule-4-paragraph-44

Application of this Schedule · 1 provisions

1 uk:uksi/2012/1916#schedule-5-paragraph-1

Appointment of reviewers · 1 provisions

2 uk:uksi/2012/1916#schedule-5-paragraph-2

Procedure before hearing · 1 provisions

3 uk:uksi/2012/1916#schedule-5-paragraph-3

Procedure at hearing · 1 provisions

4 uk:uksi/2012/1916#schedule-5-paragraph-4

Procedure following hearing · 1 provisions

5 uk:uksi/2012/1916#schedule-5-paragraph-5

PART 1 Manufacturer's licences · 12 provisions

1 uk:uksi/2012/1916#schedule-6-paragraph-1

2 uk:uksi/2012/1916#schedule-6-paragraph-2

3 uk:uksi/2012/1916#schedule-6-paragraph-3

4 uk:uksi/2012/1916#schedule-6-paragraph-4

5 uk:uksi/2012/1916#schedule-6-paragraph-5

6 uk:uksi/2012/1916#schedule-6-paragraph-6

7 uk:uksi/2012/1916#schedule-6-paragraph-7

8 uk:uksi/2012/1916#schedule-6-paragraph-8

9 uk:uksi/2012/1916#schedule-6-paragraph-9

10 uk:uksi/2012/1916#schedule-6-paragraph-10

11 uk:uksi/2012/1916#schedule-6-paragraph-11

12 uk:uksi/2012/1916#schedule-6-paragraph-12

PART 2 Wholesale dealer's licences · 8 provisions

13 uk:uksi/2012/1916#schedule-6-paragraph-13

14 uk:uksi/2012/1916#schedule-6-paragraph-14

15 uk:uksi/2012/1916#schedule-6-paragraph-15

16 uk:uksi/2012/1916#schedule-6-paragraph-16

17 uk:uksi/2012/1916#schedule-6-paragraph-17

18 uk:uksi/2012/1916#schedule-6-paragraph-18

19 uk:uksi/2012/1916#schedule-6-paragraph-19

20 uk:uksi/2012/1916#schedule-6-paragraph-20

PART 1 Qualification requirements for qualified person · 8 provisions

1 uk:uksi/2012/1916#schedule-7-paragraph-1

2 uk:uksi/2012/1916#schedule-7-paragraph-2

3 uk:uksi/2012/1916#schedule-7-paragraph-3

4 uk:uksi/2012/1916#schedule-7-paragraph-4

5 uk:uksi/2012/1916#schedule-7-paragraph-5

6 uk:uksi/2012/1916#schedule-7-paragraph-6

7 uk:uksi/2012/1916#schedule-7-paragraph-7

8 uk:uksi/2012/1916#schedule-7-paragraph-8

PART 2 Qualified persons with long experience · 3 provisions

9 uk:uksi/2012/1916#schedule-7-paragraph-9

10 uk:uksi/2012/1916#schedule-7-paragraph-10

11 uk:uksi/2012/1916#schedule-7-paragraph-11

PART 3 Obligations of qualified person · 6 provisions

12 uk:uksi/2012/1916#schedule-7-paragraph-12

12A uk:uksi/2012/1916#schedule-7-paragraph-12A

12B uk:uksi/2012/1916#schedule-7-paragraph-12B

13 uk:uksi/2012/1916#schedule-7-paragraph-13

14 uk:uksi/2012/1916#schedule-7-paragraph-14

15 uk:uksi/2012/1916#schedule-7-paragraph-15

SCHEDULE 7A · 24 provisions

1 uk:uksi/2012/1916#schedule-7A-paragraph-1

2 uk:uksi/2012/1916#schedule-7A-paragraph-2

3 uk:uksi/2012/1916#schedule-7A-paragraph-3

4 uk:uksi/2012/1916#schedule-7A-paragraph-4

5 uk:uksi/2012/1916#schedule-7A-paragraph-5

6 uk:uksi/2012/1916#schedule-7A-paragraph-6

7 uk:uksi/2012/1916#schedule-7A-paragraph-7

8 uk:uksi/2012/1916#schedule-7A-paragraph-8

9 uk:uksi/2012/1916#schedule-7A-paragraph-9

10 uk:uksi/2012/1916#schedule-7A-paragraph-10

11 uk:uksi/2012/1916#schedule-7A-paragraph-11

12 uk:uksi/2012/1916#schedule-7A-paragraph-12

13 uk:uksi/2012/1916#schedule-7A-paragraph-13

14 uk:uksi/2012/1916#schedule-7A-paragraph-14

15 uk:uksi/2012/1916#schedule-7A-paragraph-15

16 uk:uksi/2012/1916#schedule-7A-paragraph-16

17 uk:uksi/2012/1916#schedule-7A-paragraph-17

18 uk:uksi/2012/1916#schedule-7A-paragraph-18

19 uk:uksi/2012/1916#schedule-7A-paragraph-19

20 uk:uksi/2012/1916#schedule-7A-paragraph-20

21 uk:uksi/2012/1916#schedule-7A-paragraph-21

22 uk:uksi/2012/1916#schedule-7A-paragraph-22

23 uk:uksi/2012/1916#schedule-7A-paragraph-23

24 uk:uksi/2012/1916#schedule-7A-paragraph-24

PART 1 General requirements · 23 provisions

1 uk:uksi/2012/1916#schedule-8-paragraph-1

2 uk:uksi/2012/1916#schedule-8-paragraph-2

3 uk:uksi/2012/1916#schedule-8-paragraph-3

4 uk:uksi/2012/1916#schedule-8-paragraph-4

5 uk:uksi/2012/1916#schedule-8-paragraph-5

6 uk:uksi/2012/1916#schedule-8-paragraph-6

7 uk:uksi/2012/1916#schedule-8-paragraph-7

8 uk:uksi/2012/1916#schedule-8-paragraph-8

9 uk:uksi/2012/1916#schedule-8-paragraph-9

9A uk:uksi/2012/1916#schedule-8-paragraph-9A

10 uk:uksi/2012/1916#schedule-8-paragraph-10

11 uk:uksi/2012/1916#schedule-8-paragraph-11

12 uk:uksi/2012/1916#schedule-8-paragraph-12

13 uk:uksi/2012/1916#schedule-8-paragraph-13

14 uk:uksi/2012/1916#schedule-8-paragraph-14

15 uk:uksi/2012/1916#schedule-8-paragraph-15

16 uk:uksi/2012/1916#schedule-8-paragraph-16

17 uk:uksi/2012/1916#schedule-8-paragraph-17

18 uk:uksi/2012/1916#schedule-8-paragraph-18

19 uk:uksi/2012/1916#schedule-8-paragraph-19

20 uk:uksi/2012/1916#schedule-8-paragraph-20

21 uk:uksi/2012/1916#schedule-8-paragraph-21

22 uk:uksi/2012/1916#schedule-8-paragraph-22

PART 2 Summary of the product characteristics · 15 provisions

23 uk:uksi/2012/1916#schedule-8-paragraph-23

24 uk:uksi/2012/1916#schedule-8-paragraph-24

25 uk:uksi/2012/1916#schedule-8-paragraph-25

25A uk:uksi/2012/1916#schedule-8-paragraph-25A

26 uk:uksi/2012/1916#schedule-8-paragraph-26

27 uk:uksi/2012/1916#schedule-8-paragraph-27

28 uk:uksi/2012/1916#schedule-8-paragraph-28

29 uk:uksi/2012/1916#schedule-8-paragraph-29

30 uk:uksi/2012/1916#schedule-8-paragraph-30

31 uk:uksi/2012/1916#schedule-8-paragraph-31

32 uk:uksi/2012/1916#schedule-8-paragraph-32

33 uk:uksi/2012/1916#schedule-8-paragraph-33

34 uk:uksi/2012/1916#schedule-8-paragraph-34

35 uk:uksi/2012/1916#schedule-8-paragraph-35

36 uk:uksi/2012/1916#schedule-8-paragraph-36

SCHEDULE8A · 9 provisions

1 uk:uksi/2012/1916#schedule-8A-paragraph-1

2 uk:uksi/2012/1916#schedule-8A-paragraph-2

3 uk:uksi/2012/1916#schedule-8A-paragraph-3

4 uk:uksi/2012/1916#schedule-8A-paragraph-4

5 uk:uksi/2012/1916#schedule-8A-paragraph-5

6 uk:uksi/2012/1916#schedule-8A-paragraph-6

7 uk:uksi/2012/1916#schedule-8A-paragraph-7

8 uk:uksi/2012/1916#schedule-8A-paragraph-8

9 uk:uksi/2012/1916#schedule-8A-paragraph-9

SCHEDULE 8C · 3 provisions

1 uk:uksi/2012/1916#schedule-8C-paragraph-1

2 uk:uksi/2012/1916#schedule-8C-paragraph-2

3 uk:uksi/2012/1916#schedule-8C-paragraph-3

SCHEDULE 9 · 12 provisions

1 uk:uksi/2012/1916#schedule-9-paragraph-1

2 uk:uksi/2012/1916#schedule-9-paragraph-2

3 uk:uksi/2012/1916#schedule-9-paragraph-3

4 uk:uksi/2012/1916#schedule-9-paragraph-4

5 uk:uksi/2012/1916#schedule-9-paragraph-5

6 uk:uksi/2012/1916#schedule-9-paragraph-6

7 uk:uksi/2012/1916#schedule-9-paragraph-7

8 uk:uksi/2012/1916#schedule-9-paragraph-8

9 uk:uksi/2012/1916#schedule-9-paragraph-9

10 uk:uksi/2012/1916#schedule-9-paragraph-10

11 uk:uksi/2012/1916#schedule-9-paragraph-11

12 uk:uksi/2012/1916#schedule-9-paragraph-12

SCHEDULE 9A · 8 provisions

1 Prevalence of a condition in the United Kingdom uk:uksi/2012/1916#schedule-9A-paragraph-1

2 Potential for return on investment uk:uksi/2012/1916#schedule-9A-paragraph-2

3 Existence of other methods of diagnosis, prevention or treatment uk:uksi/2012/1916#schedule-9A-paragraph-3

4 Increased safety or effectiveness and clinical superiority uk:uksi/2012/1916#schedule-9A-paragraph-4

5 uk:uksi/2012/1916#schedule-9A-paragraph-5

6 uk:uksi/2012/1916#schedule-9A-paragraph-6

7 uk:uksi/2012/1916#schedule-9A-paragraph-7

8 uk:uksi/2012/1916#schedule-9A-paragraph-8

Meaning of “national homoeopathic product” · 1 provisions

1 uk:uksi/2012/1916#schedule-10-paragraph-1

General requirements for application · 1 provisions

2 uk:uksi/2012/1916#schedule-10-paragraph-2

Requirement to submit safety data · 1 provisions

3 uk:uksi/2012/1916#schedule-10-paragraph-3

Exceptions to requirement to submit safety data · 1 provisions

4 uk:uksi/2012/1916#schedule-10-paragraph-4

Requirement to submit efficacy data · 1 provisions

5 uk:uksi/2012/1916#schedule-10-paragraph-5

SCHEDULE 10A · 17 provisions

1 Interpretation uk:uksi/2012/1916#schedule-10A-paragraph-1

2 Classification of variations uk:uksi/2012/1916#schedule-10A-paragraph-2

3 Licensing authority recommendation on unclassified variations uk:uksi/2012/1916#schedule-10A-paragraph-3

4 Variations leading to the revision of product information uk:uksi/2012/1916#schedule-10A-paragraph-4

5 Grouping of variations uk:uksi/2012/1916#schedule-10A-paragraph-5

6 Notification procedure for minor variations of type IA uk:uksi/2012/1916#schedule-10A-paragraph-6

7 Notification procedure for minor variations of type IB uk:uksi/2012/1916#schedule-10A-paragraph-7

8 Prior approval procedure for major variations of type II uk:uksi/2012/1916#schedule-10A-paragraph-8

9 Elements to be submitted uk:uksi/2012/1916#schedule-10A-paragraph-9

10 Measures to close the procedures specified in paragraphs 6 to 8 uk:uksi/2012/1916#schedule-10A-paragraph-10

11 Extensions of marketing authorisations uk:uksi/2012/1916#schedule-10A-paragraph-11

12 Human influenza vaccines uk:uksi/2012/1916#schedule-10A-paragraph-12

13 Pandemic situation with respect to human influenza uk:uksi/2012/1916#schedule-10A-paragraph-13

14 Urgent safety restrictions uk:uksi/2012/1916#schedule-10A-paragraph-14

15 Amendments to the decision granting the marketing authorisation uk:uksi/2012/1916#schedule-10A-paragraph-15

16 Implementation of variations uk:uksi/2012/1916#schedule-10A-paragraph-16

17 Continuous monitoring uk:uksi/2012/1916#schedule-10A-paragraph-17

PART 1 General procedures · 13 provisions

1 uk:uksi/2012/1916#schedule-11-paragraph-1

2 uk:uksi/2012/1916#schedule-11-paragraph-2

3 uk:uksi/2012/1916#schedule-11-paragraph-3

4 uk:uksi/2012/1916#schedule-11-paragraph-4

5 uk:uksi/2012/1916#schedule-11-paragraph-5

6 uk:uksi/2012/1916#schedule-11-paragraph-6

7 uk:uksi/2012/1916#schedule-11-paragraph-7

8 uk:uksi/2012/1916#schedule-11-paragraph-8

9 uk:uksi/2012/1916#schedule-11-paragraph-9

10 uk:uksi/2012/1916#schedule-11-paragraph-10

11 uk:uksi/2012/1916#schedule-11-paragraph-11

12 uk:uksi/2012/1916#schedule-11-paragraph-12

13 uk:uksi/2012/1916#schedule-11-paragraph-13

PART 1A Paediatric Decisions · 7 provisions

13A Application of this Part uk:uksi/2012/1916#schedule-11-paragraph-13A

13B Opportunity to make representations uk:uksi/2012/1916#schedule-11-paragraph-13B

13C Written representations uk:uksi/2012/1916#schedule-11-paragraph-13C

13D Oral representations uk:uksi/2012/1916#schedule-11-paragraph-13D

13E Other decisions of the appropriate committee uk:uksi/2012/1916#schedule-11-paragraph-13E

13F Decision of licensing authority uk:uksi/2012/1916#schedule-11-paragraph-13F

13G Right to review after paragraph 13F notification uk:uksi/2012/1916#schedule-11-paragraph-13G

PART 2 Type II variation applications, complex variation applications and new excipient variation applications · 10 provisions

14 uk:uksi/2012/1916#schedule-11-paragraph-14

15 uk:uksi/2012/1916#schedule-11-paragraph-15

16 uk:uksi/2012/1916#schedule-11-paragraph-16

17 uk:uksi/2012/1916#schedule-11-paragraph-17

18 uk:uksi/2012/1916#schedule-11-paragraph-18

19 uk:uksi/2012/1916#schedule-11-paragraph-19

20 uk:uksi/2012/1916#schedule-11-paragraph-20

21 uk:uksi/2012/1916#schedule-11-paragraph-21

22 uk:uksi/2012/1916#schedule-11-paragraph-22

23 uk:uksi/2012/1916#schedule-11-paragraph-23

PART 3 Referral to the appropriate committee for traditional herbal registrations · 7 provisions

24 uk:uksi/2012/1916#schedule-11-paragraph-24

25 uk:uksi/2012/1916#schedule-11-paragraph-25

26 uk:uksi/2012/1916#schedule-11-paragraph-26

27 uk:uksi/2012/1916#schedule-11-paragraph-27

28 uk:uksi/2012/1916#schedule-11-paragraph-28

29 uk:uksi/2012/1916#schedule-11-paragraph-29

30 uk:uksi/2012/1916#schedule-11-paragraph-30

PART 4 Exceptions to Schedule · 9 provisions

31 uk:uksi/2012/1916#schedule-11-paragraph-31

32 uk:uksi/2012/1916#schedule-11-paragraph-32

33 uk:uksi/2012/1916#schedule-11-paragraph-33

34 uk:uksi/2012/1916#schedule-11-paragraph-34

35 uk:uksi/2012/1916#schedule-11-paragraph-35

36 uk:uksi/2012/1916#schedule-11-paragraph-36

37 uk:uksi/2012/1916#schedule-11-paragraph-37

38 uk:uksi/2012/1916#schedule-11-paragraph-38

39 uk:uksi/2012/1916#schedule-11-paragraph-39

PART 1 General requirements · 20 provisions

1 uk:uksi/2012/1916#schedule-12-paragraph-1

2 uk:uksi/2012/1916#schedule-12-paragraph-2

3 uk:uksi/2012/1916#schedule-12-paragraph-3

4 uk:uksi/2012/1916#schedule-12-paragraph-4

5 uk:uksi/2012/1916#schedule-12-paragraph-5

6 uk:uksi/2012/1916#schedule-12-paragraph-6

7 uk:uksi/2012/1916#schedule-12-paragraph-7

8 uk:uksi/2012/1916#schedule-12-paragraph-8

9 uk:uksi/2012/1916#schedule-12-paragraph-9

10 uk:uksi/2012/1916#schedule-12-paragraph-10

11 uk:uksi/2012/1916#schedule-12-paragraph-11

12 uk:uksi/2012/1916#schedule-12-paragraph-12

13 uk:uksi/2012/1916#schedule-12-paragraph-13

14 uk:uksi/2012/1916#schedule-12-paragraph-14

15 uk:uksi/2012/1916#schedule-12-paragraph-15

16 uk:uksi/2012/1916#schedule-12-paragraph-16

17 uk:uksi/2012/1916#schedule-12-paragraph-17

18 uk:uksi/2012/1916#schedule-12-paragraph-18

19 uk:uksi/2012/1916#schedule-12-paragraph-19

20 uk:uksi/2012/1916#schedule-12-paragraph-20

PART 2 Summary of the product characteristics · 10 provisions

21 uk:uksi/2012/1916#schedule-12-paragraph-21

22 uk:uksi/2012/1916#schedule-12-paragraph-22

23 uk:uksi/2012/1916#schedule-12-paragraph-23

24 uk:uksi/2012/1916#schedule-12-paragraph-24

25 uk:uksi/2012/1916#schedule-12-paragraph-25

26 uk:uksi/2012/1916#schedule-12-paragraph-26

27 uk:uksi/2012/1916#schedule-12-paragraph-27

28 uk:uksi/2012/1916#schedule-12-paragraph-28

29 uk:uksi/2012/1916#schedule-12-paragraph-29

30 uk:uksi/2012/1916#schedule-12-paragraph-30

PART 1 Pharmacovigilance system master file · 7 provisions

1 Structure of the pharmacovigilance system master file uk:uksi/2012/1916#schedule-12A-paragraph-1

2 Content of the pharmacovigilance system master file uk:uksi/2012/1916#schedule-12A-paragraph-2

3 Content of the Annex to the pharmacovigilance system master file uk:uksi/2012/1916#schedule-12A-paragraph-3

4 Maintenance of the pharmacovigilance system master file uk:uksi/2012/1916#schedule-12A-paragraph-4

5 Form of the documents contained in the pharmacovigilance system master file uk:uksi/2012/1916#schedule-12A-paragraph-5

6 Subcontracting uk:uksi/2012/1916#schedule-12A-paragraph-6

7 Availability and location of the pharmacovigilance system master file uk:uksi/2012/1916#schedule-12A-paragraph-7

PART 2 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority and holders · 2 provisions

8 Quality system uk:uksi/2012/1916#schedule-12A-paragraph-8

9 Performance indicators uk:uksi/2012/1916#schedule-12A-paragraph-9

PART 3 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by holders · 4 provisions

10 Management of human resources uk:uksi/2012/1916#schedule-12A-paragraph-10

11 Compliance management uk:uksi/2012/1916#schedule-12A-paragraph-11

12 Record management and data retention uk:uksi/2012/1916#schedule-12A-paragraph-12

13 Audit uk:uksi/2012/1916#schedule-12A-paragraph-13

PART 4 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority · 4 provisions

14 Management of human resources uk:uksi/2012/1916#schedule-12A-paragraph-14

15 Compliance management uk:uksi/2012/1916#schedule-12A-paragraph-15

16 Record management and data retention uk:uksi/2012/1916#schedule-12A-paragraph-16

17 Audit uk:uksi/2012/1916#schedule-12A-paragraph-17

PART 5 Use of terminology, formats and standards · 1 provisions

18 Use of internationally agreed terminology, formats and standards uk:uksi/2012/1916#schedule-12A-paragraph-18

PART 6 Transmission of reports of suspected adverse reactions · 3 provisions

19 Individual case safety reports uk:uksi/2012/1916#schedule-12A-paragraph-19

20 Content of the individual case safety report uk:uksi/2012/1916#schedule-12A-paragraph-20

21 Format of electronic transmission of suspected adverse reactions uk:uksi/2012/1916#schedule-12A-paragraph-21

PART 7 Risk management plans · 4 provisions

22 Content of the risk management plan uk:uksi/2012/1916#schedule-12A-paragraph-22

23 Summary of the risk management plan uk:uksi/2012/1916#schedule-12A-paragraph-23

24 Updates of the risk management plan uk:uksi/2012/1916#schedule-12A-paragraph-24

25 Format of the risk management plan uk:uksi/2012/1916#schedule-12A-paragraph-25

PART 8 Periodic safety update reports · 2 provisions

26 Content of periodic safety update reports uk:uksi/2012/1916#schedule-12A-paragraph-26

27 Format of periodic safety update reports uk:uksi/2012/1916#schedule-12A-paragraph-27

PART 9 Post-authorisation safety studies · 5 provisions

28 Scope and interpretation uk:uksi/2012/1916#schedule-12A-paragraph-28

29 Obligations as to post-authorisation safety studies uk:uksi/2012/1916#schedule-12A-paragraph-29

30 Format of the study protocol uk:uksi/2012/1916#schedule-12A-paragraph-30

31 Format of the abstract of the final study report uk:uksi/2012/1916#schedule-12A-paragraph-31

32 Format of the final study report uk:uksi/2012/1916#schedule-12A-paragraph-32

SCHEDULE 15 · 2 provisions

1 uk:uksi/2012/1916#schedule-15-paragraph-1

2 uk:uksi/2012/1916#schedule-15-paragraph-2

PART 1 Particulars to be included in a patient group direction and a vaccine group direction · 17 provisions

1 uk:uksi/2012/1916#schedule-16-paragraph-1

2 uk:uksi/2012/1916#schedule-16-paragraph-2

3 uk:uksi/2012/1916#schedule-16-paragraph-3

4 uk:uksi/2012/1916#schedule-16-paragraph-4

5 uk:uksi/2012/1916#schedule-16-paragraph-5

6 uk:uksi/2012/1916#schedule-16-paragraph-6

7 uk:uksi/2012/1916#schedule-16-paragraph-7

8 uk:uksi/2012/1916#schedule-16-paragraph-8

9 uk:uksi/2012/1916#schedule-16-paragraph-9

10 uk:uksi/2012/1916#schedule-16-paragraph-10

11 uk:uksi/2012/1916#schedule-16-paragraph-11

12 uk:uksi/2012/1916#schedule-16-paragraph-12

13 uk:uksi/2012/1916#schedule-16-paragraph-13

14 uk:uksi/2012/1916#schedule-16-paragraph-14

15 uk:uksi/2012/1916#schedule-16-paragraph-15

16 uk:uksi/2012/1916#schedule-16-paragraph-16

17 uk:uksi/2012/1916#schedule-16-paragraph-17

SCHEDULE 23 · 6 provisions

1 uk:uksi/2012/1916#schedule-23-paragraph-1

2 uk:uksi/2012/1916#schedule-23-paragraph-2

3 uk:uksi/2012/1916#schedule-23-paragraph-3

4 uk:uksi/2012/1916#schedule-23-paragraph-4

5 uk:uksi/2012/1916#schedule-23-paragraph-5

6 uk:uksi/2012/1916#schedule-23-paragraph-6

PART 1 Outer and immediate packaging · 20 provisions

1 uk:uksi/2012/1916#schedule-24-paragraph-1

2 uk:uksi/2012/1916#schedule-24-paragraph-2

3 uk:uksi/2012/1916#schedule-24-paragraph-3

4 uk:uksi/2012/1916#schedule-24-paragraph-4

5 uk:uksi/2012/1916#schedule-24-paragraph-5

6 uk:uksi/2012/1916#schedule-24-paragraph-6

7 uk:uksi/2012/1916#schedule-24-paragraph-7

8 uk:uksi/2012/1916#schedule-24-paragraph-8

9 uk:uksi/2012/1916#schedule-24-paragraph-9

10 uk:uksi/2012/1916#schedule-24-paragraph-10

11 uk:uksi/2012/1916#schedule-24-paragraph-11

12 uk:uksi/2012/1916#schedule-24-paragraph-12

13 uk:uksi/2012/1916#schedule-24-paragraph-13

14 uk:uksi/2012/1916#schedule-24-paragraph-14

15 uk:uksi/2012/1916#schedule-24-paragraph-15

16 uk:uksi/2012/1916#schedule-24-paragraph-16

17 uk:uksi/2012/1916#schedule-24-paragraph-17

18 uk:uksi/2012/1916#schedule-24-paragraph-18

18A uk:uksi/2012/1916#schedule-24-paragraph-18A

18B uk:uksi/2012/1916#schedule-24-paragraph-18B

PART 2 Immediate packaging: blister packs · 7 provisions

19 uk:uksi/2012/1916#schedule-24-paragraph-19

20 uk:uksi/2012/1916#schedule-24-paragraph-20

21 uk:uksi/2012/1916#schedule-24-paragraph-21

22 uk:uksi/2012/1916#schedule-24-paragraph-22

23 uk:uksi/2012/1916#schedule-24-paragraph-23

24 uk:uksi/2012/1916#schedule-24-paragraph-24

25 uk:uksi/2012/1916#schedule-24-paragraph-25

PART 3 Immediate packaging: small packages · 8 provisions

26 uk:uksi/2012/1916#schedule-24-paragraph-26

27 uk:uksi/2012/1916#schedule-24-paragraph-27

28 uk:uksi/2012/1916#schedule-24-paragraph-28

29 uk:uksi/2012/1916#schedule-24-paragraph-29

30 uk:uksi/2012/1916#schedule-24-paragraph-30

31 uk:uksi/2012/1916#schedule-24-paragraph-31

32 uk:uksi/2012/1916#schedule-24-paragraph-32

33 uk:uksi/2012/1916#schedule-24-paragraph-33

PART 4 Outer and immediate packaging: advanced therapy medicinal products ... · 17 provisions

34 uk:uksi/2012/1916#schedule-24-paragraph-34

35 uk:uksi/2012/1916#schedule-24-paragraph-35

36 uk:uksi/2012/1916#schedule-24-paragraph-36

37 uk:uksi/2012/1916#schedule-24-paragraph-37

38 uk:uksi/2012/1916#schedule-24-paragraph-38

39 uk:uksi/2012/1916#schedule-24-paragraph-39

40 uk:uksi/2012/1916#schedule-24-paragraph-40

41 uk:uksi/2012/1916#schedule-24-paragraph-41

42 uk:uksi/2012/1916#schedule-24-paragraph-42

43 uk:uksi/2012/1916#schedule-24-paragraph-43

44 uk:uksi/2012/1916#schedule-24-paragraph-44

45 uk:uksi/2012/1916#schedule-24-paragraph-45

46 uk:uksi/2012/1916#schedule-24-paragraph-46

47 uk:uksi/2012/1916#schedule-24-paragraph-47

48 uk:uksi/2012/1916#schedule-24-paragraph-48

49 uk:uksi/2012/1916#schedule-24-paragraph-49

50 uk:uksi/2012/1916#schedule-24-paragraph-50

PART 5 Immediate packaging: blister packs and small packaging (advanced therapy medicinal products ...) · 3 provisions

51 uk:uksi/2012/1916#schedule-24-paragraph-51

52 uk:uksi/2012/1916#schedule-24-paragraph-52

53 uk:uksi/2012/1916#schedule-24-paragraph-53

PART 6 Outer and Immediate Packaging: POC Medicinal Products for sale or supply in Great Britain only · 17 provisions

54 uk:uksi/2012/1916#schedule-24-paragraph-54

55 uk:uksi/2012/1916#schedule-24-paragraph-55

56 uk:uksi/2012/1916#schedule-24-paragraph-56

57 uk:uksi/2012/1916#schedule-24-paragraph-57

58 uk:uksi/2012/1916#schedule-24-paragraph-58

59 uk:uksi/2012/1916#schedule-24-paragraph-59

60 uk:uksi/2012/1916#schedule-24-paragraph-60

61 uk:uksi/2012/1916#schedule-24-paragraph-61

62 uk:uksi/2012/1916#schedule-24-paragraph-62

63 uk:uksi/2012/1916#schedule-24-paragraph-63

64 uk:uksi/2012/1916#schedule-24-paragraph-64

65 uk:uksi/2012/1916#schedule-24-paragraph-65

66 uk:uksi/2012/1916#schedule-24-paragraph-66

67 uk:uksi/2012/1916#schedule-24-paragraph-67

68 uk:uksi/2012/1916#schedule-24-paragraph-68

69 uk:uksi/2012/1916#schedule-24-paragraph-69

70 uk:uksi/2012/1916#schedule-24-paragraph-70

PART 7 Immediate Packaging: Blister Packs and Small Packaging (POC Medicinal Products for sale or supply in Great Britain only) · 10 provisions

71 uk:uksi/2012/1916#schedule-24-paragraph-71

72 uk:uksi/2012/1916#schedule-24-paragraph-72

73 uk:uksi/2012/1916#schedule-24-paragraph-73

74 uk:uksi/2012/1916#schedule-24-paragraph-74

75 uk:uksi/2012/1916#schedule-24-paragraph-75

76 uk:uksi/2012/1916#schedule-24-paragraph-76

77 uk:uksi/2012/1916#schedule-24-paragraph-77

78 uk:uksi/2012/1916#schedule-24-paragraph-78

79 uk:uksi/2012/1916#schedule-24-paragraph-79

80 uk:uksi/2012/1916#schedule-24-paragraph-80

PART 1 Medicines on prescription · 7 provisions

1 uk:uksi/2012/1916#schedule-25-paragraph-1

2 uk:uksi/2012/1916#schedule-25-paragraph-2

3 uk:uksi/2012/1916#schedule-25-paragraph-3

4 uk:uksi/2012/1916#schedule-25-paragraph-4

5 uk:uksi/2012/1916#schedule-25-paragraph-5

6 uk:uksi/2012/1916#schedule-25-paragraph-6

6A uk:uksi/2012/1916#schedule-25-paragraph-6A

PART 2 Transport, delivery and storage · 3 provisions

7 uk:uksi/2012/1916#schedule-25-paragraph-7

8 uk:uksi/2012/1916#schedule-25-paragraph-8

9 uk:uksi/2012/1916#schedule-25-paragraph-9

PART 3 Pharmacy and prescription only medicines · 4 provisions

10 uk:uksi/2012/1916#schedule-25-paragraph-10

11 uk:uksi/2012/1916#schedule-25-paragraph-11

12 uk:uksi/2012/1916#schedule-25-paragraph-12

13 uk:uksi/2012/1916#schedule-25-paragraph-13

PART 4 Medicines containing paracetamol · 5 provisions

14 uk:uksi/2012/1916#schedule-25-paragraph-14

15 uk:uksi/2012/1916#schedule-25-paragraph-15

16 uk:uksi/2012/1916#schedule-25-paragraph-16

17 uk:uksi/2012/1916#schedule-25-paragraph-17

18 uk:uksi/2012/1916#schedule-25-paragraph-18

PART 1 Supply by doctors, dentists, nurses, midwives and pharmacists · 5 provisions

1 uk:uksi/2012/1916#schedule-26-paragraph-1

2 uk:uksi/2012/1916#schedule-26-paragraph-2

3 uk:uksi/2012/1916#schedule-26-paragraph-3

4 uk:uksi/2012/1916#schedule-26-paragraph-4

4A uk:uksi/2012/1916#schedule-26-paragraph-4A

PART 2 Pharmacy exceptions · 8 provisions

5 uk:uksi/2012/1916#schedule-26-paragraph-5

6 uk:uksi/2012/1916#schedule-26-paragraph-6

7 uk:uksi/2012/1916#schedule-26-paragraph-7

8 uk:uksi/2012/1916#schedule-26-paragraph-8

9 uk:uksi/2012/1916#schedule-26-paragraph-9

10 uk:uksi/2012/1916#schedule-26-paragraph-10

10A uk:uksi/2012/1916#schedule-26-paragraph-10A

11 uk:uksi/2012/1916#schedule-26-paragraph-11

PART 1 General requirements · 15 provisions

1 uk:uksi/2012/1916#schedule-27-paragraph-1

2 uk:uksi/2012/1916#schedule-27-paragraph-2

3 uk:uksi/2012/1916#schedule-27-paragraph-3

4 uk:uksi/2012/1916#schedule-27-paragraph-4

5 uk:uksi/2012/1916#schedule-27-paragraph-5

6 uk:uksi/2012/1916#schedule-27-paragraph-6

7 uk:uksi/2012/1916#schedule-27-paragraph-7

8 uk:uksi/2012/1916#schedule-27-paragraph-8

9 uk:uksi/2012/1916#schedule-27-paragraph-9

10 uk:uksi/2012/1916#schedule-27-paragraph-10

11 uk:uksi/2012/1916#schedule-27-paragraph-11

12 uk:uksi/2012/1916#schedule-27-paragraph-12

13 uk:uksi/2012/1916#schedule-27-paragraph-13

14 uk:uksi/2012/1916#schedule-27-paragraph-14

15 uk:uksi/2012/1916#schedule-27-paragraph-15

PART 2 Paracetamol · 2 provisions

16 uk:uksi/2012/1916#schedule-27-paragraph-16

17 uk:uksi/2012/1916#schedule-27-paragraph-17

Part 3 Advanced therapy medicinal products ... · 13 provisions

18 uk:uksi/2012/1916#schedule-27-paragraph-18

19 uk:uksi/2012/1916#schedule-27-paragraph-19

20 uk:uksi/2012/1916#schedule-27-paragraph-20

21 uk:uksi/2012/1916#schedule-27-paragraph-21

22 uk:uksi/2012/1916#schedule-27-paragraph-22

23 uk:uksi/2012/1916#schedule-27-paragraph-23

24 uk:uksi/2012/1916#schedule-27-paragraph-24

25 uk:uksi/2012/1916#schedule-27-paragraph-25

26 uk:uksi/2012/1916#schedule-27-paragraph-26

27 uk:uksi/2012/1916#schedule-27-paragraph-27

28 uk:uksi/2012/1916#schedule-27-paragraph-28

29 uk:uksi/2012/1916#schedule-27-paragraph-29

30 uk:uksi/2012/1916#schedule-27-paragraph-30

PART 1 Outer and immediate packaging · 12 provisions

1 uk:uksi/2012/1916#schedule-28-paragraph-1

2 uk:uksi/2012/1916#schedule-28-paragraph-2

3 uk:uksi/2012/1916#schedule-28-paragraph-3

4 uk:uksi/2012/1916#schedule-28-paragraph-4

5 uk:uksi/2012/1916#schedule-28-paragraph-5

6 uk:uksi/2012/1916#schedule-28-paragraph-6

7 uk:uksi/2012/1916#schedule-28-paragraph-7

8 uk:uksi/2012/1916#schedule-28-paragraph-8

9 uk:uksi/2012/1916#schedule-28-paragraph-9

10 uk:uksi/2012/1916#schedule-28-paragraph-10

11 uk:uksi/2012/1916#schedule-28-paragraph-11

12 uk:uksi/2012/1916#schedule-28-paragraph-12

PART 2 Blister packs etc contained in outer packaging · 5 provisions

13 uk:uksi/2012/1916#schedule-28-paragraph-13

14 uk:uksi/2012/1916#schedule-28-paragraph-14

15 uk:uksi/2012/1916#schedule-28-paragraph-15

16 uk:uksi/2012/1916#schedule-28-paragraph-16

17 uk:uksi/2012/1916#schedule-28-paragraph-17

PART 3 Small immediate packaging · 7 provisions

18 uk:uksi/2012/1916#schedule-28-paragraph-18

19 uk:uksi/2012/1916#schedule-28-paragraph-19

20 uk:uksi/2012/1916#schedule-28-paragraph-20

21 uk:uksi/2012/1916#schedule-28-paragraph-21

22 uk:uksi/2012/1916#schedule-28-paragraph-22

23 uk:uksi/2012/1916#schedule-28-paragraph-23

24 uk:uksi/2012/1916#schedule-28-paragraph-24

PART 1 Traditional herbal medicinal products: general · 2 provisions

1 uk:uksi/2012/1916#schedule-29-paragraph-1

2 uk:uksi/2012/1916#schedule-29-paragraph-2

PART 2 Traditional herbal medicinal products not subject to general sale · 2 provisions

3 uk:uksi/2012/1916#schedule-29-paragraph-3

4 uk:uksi/2012/1916#schedule-29-paragraph-4

SCHEDULE 30 · 10 provisions

1 uk:uksi/2012/1916#schedule-30-paragraph-1

2 uk:uksi/2012/1916#schedule-30-paragraph-2

2A uk:uksi/2012/1916#schedule-30-paragraph-2A

3 uk:uksi/2012/1916#schedule-30-paragraph-3

4 uk:uksi/2012/1916#schedule-30-paragraph-4

5 uk:uksi/2012/1916#schedule-30-paragraph-5

6 uk:uksi/2012/1916#schedule-30-paragraph-6

7 uk:uksi/2012/1916#schedule-30-paragraph-7

8 uk:uksi/2012/1916#schedule-30-paragraph-8

9 uk:uksi/2012/1916#schedule-30-paragraph-9

Introductory · 1 provisions

1 uk:uksi/2012/1916#schedule-31-paragraph-1

Division of sample · 12 provisions

2 uk:uksi/2012/1916#schedule-31-paragraph-2

3 uk:uksi/2012/1916#schedule-31-paragraph-3

4 uk:uksi/2012/1916#schedule-31-paragraph-4

5 uk:uksi/2012/1916#schedule-31-paragraph-5

6 uk:uksi/2012/1916#schedule-31-paragraph-6

7 uk:uksi/2012/1916#schedule-31-paragraph-7

8 uk:uksi/2012/1916#schedule-31-paragraph-8

9 uk:uksi/2012/1916#schedule-31-paragraph-9

10 uk:uksi/2012/1916#schedule-31-paragraph-10

11 uk:uksi/2012/1916#schedule-31-paragraph-11

12 uk:uksi/2012/1916#schedule-31-paragraph-12

13 uk:uksi/2012/1916#schedule-31-paragraph-13

Notice to person named on container · 1 provisions

14 uk:uksi/2012/1916#schedule-31-paragraph-14

Analysis or other examination · 6 provisions

15 uk:uksi/2012/1916#schedule-31-paragraph-15

16 uk:uksi/2012/1916#schedule-31-paragraph-16

17 uk:uksi/2012/1916#schedule-31-paragraph-17

18 uk:uksi/2012/1916#schedule-31-paragraph-18

19 uk:uksi/2012/1916#schedule-31-paragraph-19

20 uk:uksi/2012/1916#schedule-31-paragraph-20

Provisions as to evidence · 3 provisions

21 uk:uksi/2012/1916#schedule-31-paragraph-21

22 uk:uksi/2012/1916#schedule-31-paragraph-22

23 uk:uksi/2012/1916#schedule-31-paragraph-23

Analysis under direction of court · 2 provisions

24 uk:uksi/2012/1916#schedule-31-paragraph-24

25 uk:uksi/2012/1916#schedule-31-paragraph-25

Proof by written statement · 1 provisions

26 uk:uksi/2012/1916#schedule-31-paragraph-26

Payment for sample taken under compulsory powers · 1 provisions

27 uk:uksi/2012/1916#schedule-31-paragraph-27

Continuity of the law · 1 provisions

1 uk:uksi/2012/1916#schedule-32-paragraph-1

Product licences · 1 provisions

2 uk:uksi/2012/1916#schedule-32-paragraph-2

Product licences of right · 1 provisions

3 uk:uksi/2012/1916#schedule-32-paragraph-3

Classification of UK marketing authorisation and certificate of registration · 1 provisions

4 uk:uksi/2012/1916#schedule-32-paragraph-4

Advanced therapy medicinal products · 1 provisions

5 uk:uksi/2012/1916#schedule-32-paragraph-5

Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882) · 1 provisions

6 uk:uksi/2012/1916#schedule-32-paragraph-6

Section 60 of the Medicines Act 1968 etc · 1 provisions

7 uk:uksi/2012/1916#schedule-32-paragraph-7

SCHEDULE 33 · 10 provisions

1 Pharmacovigilance system master file uk:uksi/2012/1916#schedule-33-paragraph-1

2 uk:uksi/2012/1916#schedule-33-paragraph-2

3 Post-authorisation safety studies uk:uksi/2012/1916#schedule-33-paragraph-3

4 uk:uksi/2012/1916#schedule-33-paragraph-4

5 Reporting obligations uk:uksi/2012/1916#schedule-33-paragraph-5

6 uk:uksi/2012/1916#schedule-33-paragraph-6

7 uk:uksi/2012/1916#schedule-33-paragraph-7

8 uk:uksi/2012/1916#schedule-33-paragraph-8

9 Periodic safety update reports uk:uksi/2012/1916#schedule-33-paragraph-9

10 uk:uksi/2012/1916#schedule-33-paragraph-10

PART 1 Interpretation · 1 provisions

1 uk:uksi/2012/1916#schedule-33A-paragraph-1

PART 2 Manufacturing, wholesale dealing and brokering · 4 provisions

2 Wholesale dealer's licence used to distribute a medicinal product imported from an EEA State before IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-2

3 Approved country for import list on IP completion day (regulation 18A) uk:uksi/2012/1916#schedule-33A-paragraph-3

4 Qualified persons and approved country for batch testing list on IP completion day (Schedule 7) uk:uksi/2012/1916#schedule-33A-paragraph-4

5 List of countries with equivalent regulatory standards as to the manufacturing of active substances on IP completion day (regulation 45O(6) to (9)) uk:uksi/2012/1916#schedule-33A-paragraph-5

PART 3 Transitional provision in respect of conversion of EU marketing authorisations in force immediately before IP completion day · 20 provisions

6 Conversion of EU marketing authorisations in force before IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-6

7 Classification of converted EU marketing authorisations uk:uksi/2012/1916#schedule-33A-paragraph-7

8 Obligations of licensing authority in connection with converted EU marketing authorisations uk:uksi/2012/1916#schedule-33A-paragraph-8

9 Obligations of holders of converted EU marketing authorisations uk:uksi/2012/1916#schedule-33A-paragraph-9

10 Powers of licensing authority in connection with provision of information uk:uksi/2012/1916#schedule-33A-paragraph-10

11 Variations of converted EU marketing authorisations notified or applied for before IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-11

12 Variations of converted EU marketing authorisations submitted to EMA after IP completion day but before the data submission date uk:uksi/2012/1916#schedule-33A-paragraph-12

13 Variations of converted EU marketing authorisations sought in advance of the data submission date uk:uksi/2012/1916#schedule-33A-paragraph-13

14 Applications for renewals of converted EU marketing authorisations made before IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-14

15 Applications for renewals of conditional marketing authorisations made before IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-15

16 Applications for renewals of converted EU marketing authorisations made after IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-16

17 Applications for renewals of conditional marketing authorisations made after IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-17

18 Renewals of converted EU marketing authorisations sought in advance of the data submission date uk:uksi/2012/1916#schedule-33A-paragraph-18

19 Article 61(3) notifications made before IP completion day in relation to converted EU marketing authorisations uk:uksi/2012/1916#schedule-33A-paragraph-19

20 Article 61(3) notifications made in relation to converted EU marketing authorisations after IP completion day but before the data submission date uk:uksi/2012/1916#schedule-33A-paragraph-20

21 Article 61(3) notifications sought in advance of the data submission date uk:uksi/2012/1916#schedule-33A-paragraph-21

22 Place of establishment for converted EU marketing authorisation holder established in EEA state before IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-22

23 Temporary exemption as to packaging requirements for converted EU marketing authorisations uk:uksi/2012/1916#schedule-33A-paragraph-23

24 Referrals made under Article 20 of Regulation (EC) No 726/2004 that have not concluded or been implemented before IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-24

25 Enforcement uk:uksi/2012/1916#schedule-33A-paragraph-25

PART 4 Transitional provision in respect of UK marketing authorisations, parallel import licences and parallel distribution notices · 15 provisions

26ZA Status of certain UK marketing authorisations granted before IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-26ZA

26 Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-26

27 Temporary exemption as to packaging requirements: change of place of establishment uk:uksi/2012/1916#schedule-33A-paragraph-27

27A Status of parallel import licences granted before IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-27A

28 Conversion of parallel distribution notices in to parallel import licences uk:uksi/2012/1916#schedule-33A-paragraph-28

29 Inclusion of the batch testing condition in relevant UK marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60A) uk:uksi/2012/1916#schedule-33A-paragraph-29

29A Application of the batch testing requirement to relevant EU marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60B) uk:uksi/2012/1916#schedule-33A-paragraph-29A

30 Existing data and marketing exclusivity and global marketing authorisations uk:uksi/2012/1916#schedule-33A-paragraph-30

31 Applications for EU marketing authorisations made before IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-31

32 Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications) uk:uksi/2012/1916#schedule-33A-paragraph-32

33 Packaging in relation to UK marketing authorisations granted in response to application for EU marketing authorisation made before IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-33

34 Applications made for a UK marketing authorisation before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied uk:uksi/2012/1916#schedule-33A-paragraph-34

35 Transitional provision in respect of Plasma Master Files uk:uksi/2012/1916#schedule-33A-paragraph-35

36 Suspensions of UK marketing authorisations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive or Regulation (EC) No 726/2004 uk:uksi/2012/1916#schedule-33A-paragraph-36

37 Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of an EU marketing authorisation or a UK marketing authorisation that have not concluded before IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-37

PART 5 Transitional provision in relation to variations of marketing authorisations other than converted EU marketing authorisations · 3 provisions

38 Application or notification made before IP completion day in respect of a variation under Chapter IIa of Regulation (EC) No 1234/2008 (variations to purely national marketing authorisations) uk:uksi/2012/1916#schedule-33A-paragraph-38

39 Application or notification made before IP completion day in respect of a variation under Chapter II of Regulation (EC) No 1234/2008 (variations to marketing authorisations granted in accordance with Chapter 4 of the 2001 Directive) uk:uksi/2012/1916#schedule-33A-paragraph-39

40 Application or notification in respect of a variations made before IP completion day under Article 20 of Regulation (EC) No 1234/2008 (work-sharing procedure) uk:uksi/2012/1916#schedule-33A-paragraph-40

PART 6 Transitional provision in relation to the Paediatric Regulation · 2 provisions

41 Transitional provision in relation to applications made to EMA before IP completion day under the Paediatric Regulation uk:uksi/2012/1916#schedule-33A-paragraph-41

41A Transitional provision in relation to global marketing authorisations under the 2001 Directive uk:uksi/2012/1916#schedule-33A-paragraph-41A

PART 8 Transitional provision in respect of homoeopathic medicinal products · 6 provisions

43 List of countries for the purposes of the definition of “homoeopathic medicinal product” on IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-43

44 Place of establishment for holders of certificates of registration established in EEA before IP completion day uk:uksi/2012/1916#schedule-33A-paragraph-44

45 Temporary exemption as to packaging requirements: change of place of establishment uk:uksi/2012/1916#schedule-33A-paragraph-45

46 Applications made for a certificate of registration for a registrable homoeopathic product before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied uk:uksi/2012/1916#schedule-33A-paragraph-46

47 Suspensions of certificates of registration that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive uk:uksi/2012/1916#schedule-33A-paragraph-47