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 Expand all 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

2 Medicinal products

2A Definition of advanced therapy medicinal product etc.

3 Scope of these Regulations: special provisions

3A Preparation and assembly of medicinal products used for vaccination against an infectious disease or in the reformulation of such products

4 Special provisions for pharmacies etc

5 Classification of medicinal products

6 The licensing authority and the Ministers

7 Advertisements relating to medicinal products

8 General interpretation

PART 2 Administration · 8 provisions

9 Commission on Human Medicines

10 Functions of the Commission

11 British Pharmacopoeia Commission

12 Reporting to Ministers

13 Co-option of additional members of advisory bodies

14 Appointment of expert advisory groups

15 Delegation of functions to expert advisory groups

16 Further provision about advisory bodies and expert advisory groups etc

CHAPTER 1 Interpretation · 1 provisions

A17 Interpretation

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

B17 Regulations on good manufacturing practice

C17 Guidelines on good manufacturing practice and good distribution practice

CHAPTER 2 Manufacturing and wholesale dealing · 41 provisions

17 Manufacturing of medicinal products

17A Manufacturing of MM medicinal products

17B Manufacturing of POC medicinal products

18 Wholesale dealing in medicinal products

18A Approved country for import

19 Exemptions from requirement for wholesale dealer's licence

20 Mixing of medicines

21 Application for manufacturer's or wholesale dealer's licence

22 Factors relevant to determination of application for manufacturer's or wholesale dealer's licence

23 Grant or refusal of licence

24 Standard provisions of licences

25 Duration of licence

26 General power to suspend, revoke or vary licences

27 Procedure where licensing authority proposes to suspend, revoke or vary licence

27A Effect of suspension or variation relating to modular unit or POC site

28 Suspension of licence in cases of urgency

29 Variation of licence on the application of the holder

29A Variation of MM master file

29B Variation of POC master file

30 Provision of information

31 Certification of manufacturer's licence

32 Sale and supply of starting materials

33 Offence concerning data for advanced therapy medicinal products

34 Offences: breach of regulations and false information and defence concerning starting materials

35 Penalties

36 Conditions for manufacturer's licence

37 Manufacturing and assembly

37A Manufacturing and assembly of MM medicinal products: additional requirements

37B Manufacturing and assembly of POC medicinal products: additional requirements

38 Imports from states other than EEA States / countries other than approved countries for import

39 Further requirements for manufacturer's licence

40 Obligation to provide information relating to control methods

41 Requirements as to qualified persons

42 Conditions for wholesale dealer's licence

43 Obligations of licence holder

43ZA Obligations of licence holder in Great Britain supplying listed NIMAR products to Northern Ireland

43A Requirement for wholesale dealers to decommission the unique identifier

44 Requirement for wholesale dealers to deal only with specified persons

45 Requirement as to responsible persons

45AA Requirement as to responsible persons where licence holder imports from an approved country for import

45AB Register for responsible persons (import)

CHAPTER 3 Brokering · 12 provisions

45A Brokering in medicinal products

45B Application for brokering registration

45C Procedure for determining an application for broker’s registration

45D Grant or refusal of broker’s registration

45E Criteria of broker’s registration

45F Provision of information

45G Power to suspend or vary a broker’s registration or remove a broker from the register

45H Procedure where licensing authority proposes to suspend or vary a broker’s registration or remove a broker from the register

45I Suspension of a broker registration in cases of urgency

45J Variation of a broker’s registration on the application of the broker

45K Offences: breach of regulations and false information

45L Penalties

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

45M Criteria for importation, manufacture or distribution of active substances

45N Registration in relation to active substances

45O Requirements for registration as an importer, manufacturer or distributor of an active substance

45P Provision of information

45Q Power to suspend or vary or remove an active substance registration

45R Procedure where licensing authority proposes to suspend or vary an active substance registration or remove a person from the active substance register

45S Suspension of an active substance registration in cases of urgency

45T Variation of an active substance registration on an application from the registered person

45U Offences: breach of regulations and false information

45V Penalties

PART 4 Requirement for authorisation · 2 provisions

46 Requirement for authorisation

47 Breach of requirement

PART 5 Marketing authorisations · 95 provisions

48 Application of this Part

49 Application for grant of UK marketing authorisation or parallel import licence

50 Accompanying material

50A Requirement for certain applications to include results of paediatric investigation plan

50B Agreement and modification of paediatric investigation plan

50C Deferral of initiation or completion of measures in paediatric investigation plan

50D Waiver of production of information in a paediatric investigation plan

50E Application for paediatric use marketing authorisation

50F Other applications including paediatric indications

50G Applications relating to orphan medicinal products

50H Applications relating to advanced therapy medicinal products

50I Applications relating to conditional marketing authorisations ...

50J Applications in relation to medicinal products containing or consisting of genetically modified organisms

50K Applications relating to POC medicinal products

51 Application for UKMA(NI) relating to generic medicinal products

51A Application for UKMA(GB) relating to generic medicinal products

51B Application for UKMA(UK) relating to generic medicinal products

52 Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc

52A Application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etc

52B Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc.

53 Application for UKMA(NI) relating to similar biological medicinal products

53A Application for UKMA(GB) relating to similar biological medicinal products

53B Application for UKMA(UK) relating to similar biological medicinal products

54 Applications relating to products in well-established medicinal use

55 Applications relating to new combinations of active substances

56 Applications containing information supplied in relation to another product with consent

57 Obligation to update information supplied in connection with application

57A Obligation to update information supplied in connection with parallel import licence application

58 Consideration of application

58A Paediatric rewards

58B Publication of information relating to paediatric marketing authorisations

58C Consideration of applications relating to orphan medicinal products

58D Orphan rewards

58E Consideration of applications relating to combined advanced therapy medicinal products

58F Consideration of applications relating to conditional marketing authorisations

58G Consideration of applications in relation to medicinal products containing or consisting of genetically modified organisms

59 Conditions of UK marketing authorisation or parallel import licence: general

60 Conditions of UK marketing authorisation or parallel import licence: exceptional circumstances

60A Condition as to the submitting of samples and other information to the appropriate authority

60B Submitting of samples and other information: EU marketing authorisations

61 Conditions of UK marketing authorisation: new obligations post-authorisation

62 Classification of UK marketing authorisation or parallel import licence

63 Frequency of periodic safety update reports

64 Duties of licensing authority in connection with determination

64A Obligation of licensing authority in case of change of classification

65 Validity of UK marketing authorisation

65A Validity of parallel import licence

65B Validity of conditional marketing authorisation

65C Variation of a UKMA(GB) or a UKMA(UK)(Category 1)

66 Application for renewal of authorisation

66A Application for renewal of a parallel import licence

66B Renewal of conditional marketing authorisation

67 Failure to place on the market etc

68 Revocation, variation and suspension of UK marketing authorisation or parallel import licence

69 Suspension of use etc of relevant medicinal product

70 Authorisations granted under Chapter 4 of Title III of the 2001 Directive

71 Withdrawal of medicinal product from the market

72 Sale etc of suspended medicinal product

73 Obligation to notify placing on the market etc

74 Obligation to take account of scientific and technical progress

74A Obligation to provide information relating to methods of manufacture and control: MM medicinal products

74B Obligation to provide information relating to methods of manufacture and control: POC medicinal products

75 Obligation to provide information relating to safety etc

76 Obligation in relation to product information

77 Record-keeping obligations

78 Obligation to ensure appropriate and continued supplies

78A Post authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions apply

78B Post authorisation requirements in relation to UKMA(UK)(Category 1) for advanced therapy medicinal products

79 Failure to provide information on marketing authorisations to EMA

80 Urgent safety restrictions

80A Urgent safety restrictions: parallel import licences

A81 Application of regulations 89 to 94

81 Obligation to update information supplied in connection with EU application

82 EU marketing authorisations: failure to notify placing on market etc

83 EU marketing authorisations: failure to take account of technical and scientific progress

84 EU marketing authorisations: failure to provide information as to safety etc

85 EU marketing authorisations: failure to update product information

86 EU marketing authorisations: breach of pharmacovigilance condition etc

87 Offences in connection with risk management systems and traceability systems

88 Offence concerning data for advanced therapy medicinal products

89 Offences in connection with withdrawal of product from the market

90 Failure to place on the market taking account of paediatric indication

91 Failure to notify results of third country clinical trials

92 Failure of sponsor of UK paediatric clinical trial to notify results of trial

93 Failure to notify results of paediatric study

94 Failure to submit report to EMA

94A Offences relating to Commission Regulation 2016/161

95 Offences in connection with application

95A Offences in connection with parallel import licence application

96 Provision of false or misleading information

97 Breach of pharmacovigilance condition

98 General offence of breach of provision of this Part

99 Penalties

100 Persons liable

101 Defences

PART 6 Certification of homoeopathic medicinal products · 23 provisions

102 Application of Part

103 Application for certificate of registration

104 Consideration of application

105 Conditions of certificate of registration

106 Classification of certificate of registration

107 Validity of certificate of registration

108 Application for renewal of certificate

109 Failure to place on the market etc

110 Revocation, variation and suspension of certificate of registration

111 Certificates granted under Chapter 4 of Title III of the 2001 Directive

112 Withdrawal of homoeopathic medicinal product from the market

113 Obligation to notify placing on the market etc

114 Obligation to take account of scientific and technical progress

115 Obligation to provide information relating to safety etc

116 Obligation in relation to product information

117 Record-keeping obligation

118 Obligation to ensure appropriate and continued supplies

119 Offences in connection with applications

120 Provision of false or misleading information

121 General offence of breach of provision of this Part

122 Penalties

123 Persons liable

124 Defences

PART 7 Traditional herbal registrations · 37 provisions

124A Interpretation of this Part

125 Traditional herbal medicinal products

125A List of approved countries for traditional use of a herbal medicinal product

126 Addition of vitamins or minerals

126A Licensing authority list as to herbal substances, preparations and combinations for use in traditional herbal medicinal products

127 Application for grant of traditional herbal registration

128 Accompanying material

129 Obligation to update information supplied in connection with application

130 Consideration of application

130A Procedure where less than 15 years use of traditional herbal medicinal product

131 Classification of traditional herbal registration

132 Validity of traditional herbal registration

133 Application for renewal of registration

134 Failure to place on the market etc

135 Revocation, variation and suspension of traditional herbal registration

136 Revocation by licensing authority: further provisions

137 Procedures for revocation, variation or suspension

138 Suspension of use etc of traditional herbal medicinal product

139 Registrations granted under Chapter 4 of Title III of the 2001 Directive

140 Withdrawal of traditional herbal medicinal product from the market

141 Sale etc of suspended traditional herbal medicinal product

142 Obligation to notify placing on the market etc

143 Obligation to take account of scientific and technical progress

143A Establishment of herbal monographs

144 Obligation following new herbal monograph

145 Obligation to provide information relating to safety etc

146 Obligation in relation to product information

147 Record-keeping obligations

148 Obligation to ensure appropriate and continued supplies

148A Urgent safety restrictions

149 Urgent safety restrictions

150 Offences in connection with applications

151 Provision of false or misleading information

152 General offence of breach of provision of this Part

153 Penalties

154 Persons liable

155 Defences

PART 8 Article 126a authorisations · 3 provisions

156 Article 126a authorisations

157 Requests from EU member States

158 Application of these Regulations

PART 9 Borderline products · 8 provisions

159 Provisional determination

160 Challenge to provisional determination

161 Written representations procedure

162 Oral representations procedure

163 Final determination without representations

164 Effect of final determination

165 Determination in other cases

166 Offences relating to borderline products

PART 10 Exceptions to requirement for marketing authorisation etc · 21 provisions

167 Supply to fulfil special patient needs

167A NIMAR supply to Northern Ireland

167B List of NIMAR products

167C Early Access to Medicines Scheme: establishment and licensing authority functions

167D EAMS scientific opinions ceasing to have effect

167E EAMS medicinal products: manufacture, assembly, importation, distribution and supply

167F Advertising of EAMS medicinal products

167G EAMS medicinal products: pharmacovigilance

167H Early Access to Medicines Scheme: data collection

168 Use of non-prescription medicines in the course of a business

169 Mixing of general sale medicinal products

170 Record-keeping requirements

170A MM medicinal products: pharmacovigilance requirements

170B POC medicinal products: pharmacovigilance requirements

171 Exempt advanced therapy medicinal products

172 Parallel import licences

173 Exemption for certain radiopharmaceuticals

174 Supply in response to spread of pathogenic agents etc

174A Conditions of temporary authorisations under regulation 174

175 Offences relating to exceptions

176 Penalties and supplementary provision about offences

PART 11 Pharmacovigilance · 43 provisions

177 Application of this Part and interpretation

178 General obligations of the licensing authority

179 Obligation on licensing authority to operate pharmacovigilance system

180 Obligation on licensing authority to audit pharmacovigilance system

181 Delegation of obligations under this Part

182 Obligation on holder to operate pharmacovigilance system

183 Exception to obligation to operate risk management system

184 Obligation on holder to audit pharmacovigilance system

185 Recording obligations on the licensing authority

186 Reporting obligations on the licensing authority

186A

187 Recording obligations on holders

188 Reporting obligations on holders

189 Signal detection: licensing authority obligations

190 Signal detection: holder obligation

191 Obligation on holder to submit periodic safety update reports: general requirements

191A Obligation on holder of a parallel import licence to submit periodic safety update reports

192 Obligation on holder to submit periodic safety update reports: derogation from general requirements

193 Harmonisation of PSUR frequency or date of submission

194 Responding to a single assessment of PSUR under Article 107e of the 2001 Directive

195 Obligation on licensing authority to assess PSURs ...

196 Urgent action

196A Major safety review by the licensing authority

197 EU urgent action procedure

198 Post-authorisation safety studies: general provisions

199 Submission of draft study protocols for required studies

200 Amendment to study protocols for required studies

201 Submission and evaluation of final study reports for required studies

202 Follow-up of final study reports

202A Licensing authority power in relation to medicinal products subject to additional monitoring

203 Obligations on licensing authority in relation to national medicines web-portal

204 Obligation on licensing authority in relation to public announcements

205 Obligations on holders in relation to public announcements

205A Further obligations in respect of pharmacovigilance activities

205B Guidance in respect of good pharmacovigilance practice and post authorisation efficacy studies

206 Infringement notices

207 Offences

208 False and misleading information

209 Penalties

210 Offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004

210A Offences in relation to pharmacovigilance obligations under the Implementing Regulation and Schedule 12A

211 Persons liable

212 Transitional arrangements

CHAPTER 1 Interpretation · 1 provisions

213 Interpretation

CHAPTER 2 Sale and supply of medicines · 18 provisions

214 Sale or supply of prescription only medicines

215 Prescribing and administration by supplementary prescribers

216 Exceptions to regulation 215

217 Requirements for prescriptions: general

217A Requirements for prescriptions to be dispensed in an EEA state ...

217B Original pack dispensing

217BA Original pack dispensing: Northern Ireland

217C Original pack dispensing: medicinal products containing a relevant substance

217CA Original pack dispensing: medicinal products containing a relevant substance: Northern Ireland

218 Requirements for prescriptions: approved country health professional

219 Electronic prescriptions

219A Electronic Prescriptions: approved country health professionals

220 Sale or supply of medicinal products not subject to general sale

220B Sale or supply of items dispensed by a pharmacist who is absent or treated as absent

221 Sale or supply of medicinal products subject to general sale

222 Sale of medicinal products from automatic machines

222A Assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses

222B Hub and spoke arrangements: sharing of data between different businesses

CHAPTER 3 Exemptions · 30 provisions

223 Exemptions for doctors and dentists etc

224 Emergency sale etc by pharmacist: prescriber unable to provide prescription

225 Emergency sale etc by pharmacist: at patient's request

226 Emergency sale etc by pharmacist: pandemic diseases

226A Sale etc by a pharmacist in accordance with a serious shortage protocol

227 Exemption for sale or supply in hospitals

228 Exemptions relating to prescriptions given by certain health professionals

229 Exemption for supply by national health service bodies and local authorities

230 Exemption for supply etc under a PGD to assist doctors or dentists

231 Exemption for supply etc under a PGD by independent hospitals etc

232 Exemption for supply etc under a PGD by dental practices and clinics: England and Wales

233 Exemption for supply etc under a PGD by person conducting a retail pharmacy business

234 Exemption for supply etc of products under a PGD to assist the police etc

235 Exemption for sale, supply or administration by certain persons

235A Exemption for supply or administration of certain medicines used for vaccination

236 Products consisting of or containing aloxiprin, aspirin or paracetamol

237 Products consisting of or containing pseudoephedrine salts or ephedrine base or salts

237A Appropriate suppliers of naloxone products

238 Administration of certain medicines in an emergency

239 Administration of smallpox vaccine

240 Radioactive medicinal products

241 Exemptions in respect of certain herbal remedies

242 Exemption for medicinal products at high dilution

243 Exemption for certain homoeopathic medicinal products

244 Exemption in cases involving another's default

245 Exemption in case of forged prescription

246 Exemption where requirements for prescriptions not met

247 Exemption for supply in the event or anticipation of pandemic disease

247A Protocols relating to coronavirus and influenza vaccinations and immunisations

248 Exemption for certain collection and delivery arrangements

CHAPTER 4 Miscellaneous provisions, offences and disqualification · 11 provisions

249 Restrictions on persons to be supplied with medicinal products

250 Exceptions to regulation 249

251 Compliance with standards specified in certain publications

252 Compliance with standards specified in certain publications: supplementary

253 Pharmacy records

254 Prohibitions concerning traceability of treatment with advanced therapy medicinal products

255 Offences relating to dealings with medicinal products

255A Enforcement notices relating to Commission Regulation 2016/161: persons authorised to supply medicinal products to the public

255B Exception to Article 25 of Commission Regulation 2016/161: health care institutions

255C Offences relating to Commission Regulation 2016/161: management of the repository system

256 Disqualification on conviction

PART12A Sale of medicines to the public at a distance · 15 provisions

256ZA Application of Part

256A Interpretation

256B Person who may sell medicinal products by information society services

256C Notification requirements for sellers of medicinal products at a distance

256D Procedure for listing persons who may supply medicinal products at a distance

256E Removal of a person’s entry from the list

256F Provision of information to the licensing authority

256G Grant or refusal to list a person

256H Conditions to be met by a person entered on the list

256I Power to suspend, vary or remove a person’s entry on the list

256J Procedure where the licensing authority proposes to suspend, vary or remove a person’s entry on the list

256K Suspension of a person’s entry on the list in cases of urgency

256L Variation of a person’s entry on the list on the application of that person

256M Offences: breach of regulations and false information

256N Penalties

CHAPTER 1 · 25 provisions

257 Packaging requirements: general

257AA Packaging requirements: variation in accordance with regulation 68(11I)

257AB Transitional arrangements

257A Packaging Requirements: medicinal products required to bear safety features

257B Transitional Arrangements

257C Packaging requirements: advanced therapy medicinal products

257CA Packaging requirements: POC medicinal products

257D Guidance as to packaging and package leaflets

257E Regulation-making power as to certain forms of labelling

258 Packaging requirements: specific provisions

259 Packaging requirements: information for blind and partially sighted patients

260 Package leaflets

261 Use of pictures and symbols etc

262 Labelling requirements for radionuclides

263 Leaflets relating to radionuclides

264 Homoeopathic medicines

265 Additional requirements for traditional herbal medicinal products

266 Language requirements etc

267 Submission of mock-ups of packaging and leaflets to licensing authority

268 Offence relating to packaging and package leaflets in Great Britain: holder of authorisation etc

268A Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc

269 Offences relating to packaging and package leaflets in Great Britain: other persons

269A Offences relating to packaging and package leaflets in Northern Ireland: other persons

270 Non-compliance with requirements of this Part

271 Offences: penalties

CHAPTER 2 · 5 provisions

272 Interpretation

273 Child resistant containers for regulated medicinal products

274 Exemptions from regulation 273

275 Colouring of aspirin and paracetamol products for children

276 Offences

CHAPTER 1 General · 2 provisions

277 Interpretation

278 Functions of the Ministers

CHAPTER 2 Requirements relating to advertising · 27 provisions

279 Products without a marketing authorisation etc

280 General principles

281 Duties of authorisation holders and registration holders

282 Application of regulations 283 to 292

283 Products for the purpose of inducing abortions

284 Prescription only medicines

284A Medicines with differing classification status in Great Britain and Northern Ireland

285 Narcotic and psychotropic substances

286 Material relating to diagnosis

287 Material about effects of medicinal product

288 Material about status of medicinal product

289 Recommendations by scientists etc

290 Advertisements directed at children

291 Form and content of advertisement

291A Campaigns relating to the suspected or confirmed spread of pathogenic agents etc.

292 Exception for approved vaccination campaigns

293 Prohibition of supply to the public for promotional purposes

294 General requirements

295 Abbreviated advertisements

296 Exception for advertisements intended as a reminder

297 Written material accompanying promotions

298 Free samples for persons qualified to prescribe or supply medicinal products

299 Medical sales representatives

300 Inducements and hospitality

301 Advertisements for registered homoeopathic medicinal products

302 Advertisements for traditional herbal medicinal products

303 Offences

CHAPTER 3 Monitoring of Advertising · 13 provisions

304 Requirement to provide copy advertisement

305 Invitation to make representations about compatibility

306 Decision about compatibility

307 Corrective statement

308 Offences

309 Complaints to Ministers: duty to consider

310 Complaints to Ministers: power to refer

311 Application for injunction

312 Application for injunction: accuracy of factual claim

313 Grant of injunction: publication of decision and corrective statement

314 Complaints to OFCOM

315 Public interest etc

316 Civil proceedings

PART 15 British Pharmacopoeia · 5 provisions

317 British Pharmacopoeia and compendia

318 Lists of names

319 Other documents

320 Supplementary provisions

321 Specified publications

PART 16 Enforcement · 14 provisions

322 Validity of decisions and proceedings

323 Enforcement in England, Wales and Scotland

324 Enforcement in Northern Ireland

325 Rights of entry

326 Application for warrant

327 Powers of inspection, sampling and seizure

328 Regulation 327: supplementary

329 Application of sampling procedure to substance or article seized under this Part

330 Analysis of samples: other cases

331 Findings and reports of inspections

331A Guidelines on inspections

332 Restrictions on disclosure of information

333 Protection for inspectors

334 Supplementary provisions and offences

PART 17 Miscellaneous and general · 20 provisions

335 Contravention due to fault of another person

336 Warranty as defence

337 Offences in relation to warranties and certificates

338 Offences by bodies corporate and partnerships

339 Prosecutions

340 Presumptions

341 Decisions under these Regulations

342 Time limits for provision of information etc

343 Service of documents

344 Payment of expenses by Ministers

344A Modifications to deal with serious shortages

344B Regulation making powers

345 Immunity from civil liability

345A Obligation on licensing authority to maintain list of medicinal products to which derogations have applied

346 Review

347 Transitional provisions and savings

347A Transitional provision in relation to EU exit

347B Transitional provision relating to the Windsor Framework

348 Amendments to existing law

349 Repeals and revocations

PART 1 Descriptions of certain medicinal products to be available only on prescription · 2 provisions

PART 2 Descriptions of certain medicinal products to be available only from a pharmacy · 3 provisions

Terms of appointment · 4 provisions

Facilities and proceedings · 3 provisions

Payment and expenses · 4 provisions

Status · 1 provisions

Manufacturer's licences · 1 provisions

Manufacturer’s licences (MM) · 1 provisions

Manufacturer’s licence (POC) · 1 provisions

Manufacturers' licence relating to import · 1 provisions

Wholesale dealer's licences · 1 provisions

All licences · 1 provisions

PART 1 Manufacturer's licence relating to manufacture and assembly · 16 provisions

1
2
3
4
5
6
7
8
9
10
11
12
13
14
14A
14B

Part 1A Manufacturer’s licence (MM) · 9 provisions

Part 1B Manufacturer’s Licence (POC) · 9 provisions

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
15A
16
17
18
19
20
21
22
23
23ZA
23A
23B

PART 3 Manufacturer's licence relating to exempt advanced therapy medicinal products · 4 provisions

PART 4 Wholesale dealer's licence · 19 provisions

28
29
30
31
32
33
33A
34
35
36
37
38
39
40
41
41A
42
43
44

Application of this Schedule · 1 provisions

Appointment of reviewers · 1 provisions

Procedure before hearing · 1 provisions

Procedure at hearing · 1 provisions

Procedure following hearing · 1 provisions

PART 1 Manufacturer's licences · 12 provisions

1
2
3
4
5
6
7
8
9
10
11
12

PART 2 Wholesale dealer's licences · 8 provisions

13
14
15
16
17
18
19
20

PART 1 Qualification requirements for qualified person · 8 provisions

1
2
3
4
5
6
7
8

PART 2 Qualified persons with long experience · 3 provisions

PART 3 Obligations of qualified person · 6 provisions

12A

12B

SCHEDULE 7A · 24 provisions

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24

PART 1 General requirements · 23 provisions

1
2
3
4
5
6
7
8
9
9A
10
11
12
13
14
15
16
17
18
19
20
21
22

PART 2 Summary of the product characteristics · 15 provisions

23
24
25
25A
26
27
28
29
30
31
32
33
34
35
36

SCHEDULE8A · 9 provisions

1
2
3
4
5
6
7
8
9

SCHEDULE 8C · 3 provisions

SCHEDULE 9 · 12 provisions

1
2
3
4
5
6
7
8
9
10
11
12

SCHEDULE 9A · 8 provisions

1 Prevalence of a condition in the United Kingdom
2 Potential for return on investment
3 Existence of other methods of diagnosis, prevention or treatment
4 Increased safety or effectiveness and clinical superiority
5
6
7
8

Meaning of “national homoeopathic product” · 1 provisions

General requirements for application · 1 provisions

Requirement to submit safety data · 1 provisions

Exceptions to requirement to submit safety data · 1 provisions

Requirement to submit efficacy data · 1 provisions

SCHEDULE 10A · 17 provisions

1 Interpretation

2 Classification of variations

3 Licensing authority recommendation on unclassified variations

4 Variations leading to the revision of product information

5 Grouping of variations

6 Notification procedure for minor variations of type IA

7 Notification procedure for minor variations of type IB

8 Prior approval procedure for major variations of type II

9 Elements to be submitted

10 Measures to close the procedures specified in paragraphs 6 to 8

11 Extensions of marketing authorisations

12 Human influenza vaccines

13 Pandemic situation with respect to human influenza

14 Urgent safety restrictions

15 Amendments to the decision granting the marketing authorisation

16 Implementation of variations

17 Continuous monitoring

PART 1 General procedures · 13 provisions

1
2
3
4
5
6
7
8
9
10
11
12
13

PART 1A Paediatric Decisions · 7 provisions

13A Application of this Part

13B Opportunity to make representations

13C Written representations

13D Oral representations

13E Other decisions of the appropriate committee

13F Decision of licensing authority

13G Right to review after paragraph 13F notification

PART 2 Type II variation applications, complex variation applications and new excipient variation applications · 10 provisions

14
15
16
17
18
19
20
21
22
23

PART 3 Referral to the appropriate committee for traditional herbal registrations · 7 provisions

PART 4 Exceptions to Schedule · 9 provisions

31
32
33
34
35
36
37
38
39

PART 1 General requirements · 20 provisions

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20

PART 2 Summary of the product characteristics · 10 provisions

21
22
23
24
25
26
27
28
29
30

PART 1 Pharmacovigilance system master file · 7 provisions

1 Structure of the pharmacovigilance system master file

2 Content of the pharmacovigilance system master file

3 Content of the Annex to the pharmacovigilance system master file

4 Maintenance of the pharmacovigilance system master file

5 Form of the documents contained in the pharmacovigilance system master file

6 Subcontracting

7 Availability and location of the pharmacovigilance system master file

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

9 Performance indicators

PART 3 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by holders · 4 provisions

10 Management of human resources

11 Compliance management

12 Record management and data retention

13 Audit

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

15 Compliance management

16 Record management and data retention

17 Audit

PART 5 Use of terminology, formats and standards · 1 provisions

18 Use of internationally agreed terminology, formats and standards

PART 6 Transmission of reports of suspected adverse reactions · 3 provisions

19 Individual case safety reports

20 Content of the individual case safety report

21 Format of electronic transmission of suspected adverse reactions

PART 7 Risk management plans · 4 provisions

22 Content of the risk management plan

23 Summary of the risk management plan

24 Updates of the risk management plan

25 Format of the risk management plan

PART 8 Periodic safety update reports · 2 provisions

26 Content of periodic safety update reports

27 Format of periodic safety update reports

PART 9 Post-authorisation safety studies · 5 provisions

28 Scope and interpretation

29 Obligations as to post-authorisation safety studies

30 Format of the study protocol

31 Format of the abstract of the final study report

32 Format of the final study report

SCHEDULE 15 · 2 provisions

PART 1 Particulars to be included in a patient group direction and a vaccine group direction · 17 provisions

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17

SCHEDULE 23 · 6 provisions

PART 1 Outer and immediate packaging · 20 provisions

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
18A
18B

PART 2 Immediate packaging: blister packs · 7 provisions

PART 3 Immediate packaging: small packages · 8 provisions

26
27
28
29
30
31
32
33

PART 4 Outer and immediate packaging: advanced therapy medicinal products ... · 17 provisions

34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

PART 5 Immediate packaging: blister packs and small packaging (advanced therapy medicinal products ...) · 3 provisions

PART 6 Outer and Immediate Packaging: POC Medicinal Products for sale or supply in Great Britain only · 17 provisions

54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70

PART 7 Immediate Packaging: Blister Packs and Small Packaging (POC Medicinal Products for sale or supply in Great Britain only) · 10 provisions

71
72
73
74
75
76
77
78
79
80

PART 1 Medicines on prescription · 7 provisions

PART 2 Transport, delivery and storage · 3 provisions

PART 3 Pharmacy and prescription only medicines · 4 provisions

PART 4 Medicines containing paracetamol · 5 provisions

PART 1 Supply by doctors, dentists, nurses, midwives and pharmacists · 5 provisions

PART 2 Pharmacy exceptions · 8 provisions

5
6
7
8
9
10
10A
11

PART 1 General requirements · 15 provisions

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15

PART 2 Paracetamol · 2 provisions

Part 3 Advanced therapy medicinal products ... · 13 provisions

18
19
20
21
22
23
24
25
26
27
28
29
30

PART 1 Outer and immediate packaging · 12 provisions

1
2
3
4
5
6
7
8
9
10
11
12

PART 2 Blister packs etc contained in outer packaging · 5 provisions

PART 3 Small immediate packaging · 7 provisions

PART 1 Traditional herbal medicinal products: general · 2 provisions

PART 2 Traditional herbal medicinal products not subject to general sale · 2 provisions

SCHEDULE 30 · 10 provisions

1
2
2A
3
4
5
6
7
8
9

Introductory · 1 provisions

Division of sample · 12 provisions

2
3
4
5
6
7
8
9
10
11
12
13

Notice to person named on container · 1 provisions

Analysis or other examination · 6 provisions

Provisions as to evidence · 3 provisions

Analysis under direction of court · 2 provisions

Proof by written statement · 1 provisions

Payment for sample taken under compulsory powers · 1 provisions

Continuity of the law · 1 provisions

Product licences · 1 provisions

Product licences of right · 1 provisions

Classification of UK marketing authorisation and certificate of registration · 1 provisions

Advanced therapy medicinal products · 1 provisions

Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882) · 1 provisions

Section 60 of the Medicines Act 1968 etc · 1 provisions

SCHEDULE 33 · 10 provisions

1 Pharmacovigilance system master file
2
3 Post-authorisation safety studies
4
5 Reporting obligations
6
7
8
9 Periodic safety update reports
10

PART 1 Interpretation · 1 provisions

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

3 Approved country for import list on IP completion day (regulation 18A)

4 Qualified persons and approved country for batch testing list on IP completion day (Schedule 7)

5 List of countries with equivalent regulatory standards as to the manufacturing of active substances on IP completion day (regulation 45O(6) to (9))

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

7 Classification of converted EU marketing authorisations

8 Obligations of licensing authority in connection with converted EU marketing authorisations

9 Obligations of holders of converted EU marketing authorisations

10 Powers of licensing authority in connection with provision of information

11 Variations of converted EU marketing authorisations notified or applied for before IP completion day

12 Variations of converted EU marketing authorisations submitted to EMA after IP completion day but before the data submission date

13 Variations of converted EU marketing authorisations sought in advance of the data submission date

14 Applications for renewals of converted EU marketing authorisations made before IP completion day

15 Applications for renewals of conditional marketing authorisations made before IP completion day

16 Applications for renewals of converted EU marketing authorisations made after IP completion day

17 Applications for renewals of conditional marketing authorisations made after IP completion day

18 Renewals of converted EU marketing authorisations sought in advance of the data submission date

19 Article 61(3) notifications made before IP completion day in relation to converted EU marketing authorisations

20 Article 61(3) notifications made in relation to converted EU marketing authorisations after IP completion day but before the data submission date

21 Article 61(3) notifications sought in advance of the data submission date

22 Place of establishment for converted EU marketing authorisation holder established in EEA state before IP completion day

23 Temporary exemption as to packaging requirements for converted EU marketing authorisations

24 Referrals made under Article 20 of Regulation (EC) No 726/2004 that have not concluded or been implemented before IP completion day

25 Enforcement

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

26 Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion day

27 Temporary exemption as to packaging requirements: change of place of establishment

27A Status of parallel import licences granted before IP completion day

28 Conversion of parallel distribution notices in to parallel import licences

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)

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)

30 Existing data and marketing exclusivity and global marketing authorisations

31 Applications for EU marketing authorisations made before IP completion day

32 Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications)

33 Packaging in relation to UK marketing authorisations granted in response to application for EU marketing authorisation made before IP completion day

34 Applications made for a UK marketing authorisation before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied

35 Transitional provision in respect of Plasma Master Files

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

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

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)

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)

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)

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

41A Transitional provision in relation to global marketing authorisations under the 2001 Directive

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

44 Place of establishment for holders of certificates of registration established in EEA before IP completion day

45 Temporary exemption as to packaging requirements: change of place of establishment

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

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

48 Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of a certificate of registration that have not concluded before IP completion day

PART 9 Transitional provision in respect of traditional herbal registrations · 7 provisions

49 Place of establishment for holders of traditional herbal registrations established in EEA before IP completion day

50 Temporary exemption as to packaging requirements: change of place of establishment

51 List of approved countries for traditional use of a herbal medicinal product on IP completion day

52 Applications made for a traditional herbal registration before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied

53 Suspensions of traditional herbal registrations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive

54 Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of a traditional herbal registration that have not concluded before IP completion day

55 Proposals to refer an application for a traditional herbal registration to the Committee for Herbal Medicinal Products and the procedure in Part 3 of Schedule 11 that were on-going at IP completion day

PART 10 Transitional provision in respect of pharmacovigilance · 4 provisions

58 Referrals made under Article 107i of the 2001 Directive concerning the evaluation of data from pharmacovigilance activities which are not concluded before IP completion day

59 Matters on-going at IP completion day in respect of periodic safety update reports

60 Matters on-going at IP completion day in relation to draft study protocols under Article 107n and 107o of the 2001 Directive (submission of, and amendment to, draft study protocols for required studies)

61 Matters on-going at IP completion day in respect of the follow up of final study reports

PART 11 Transitional provision in respect of Part 12 · 1 provisions

62 Approved country health professional list on IP completion day (regulation 214(6A))

PART 12 General provision in relation to transitional provisions · 1 provisions

63 Licensing authority power to require information

SCHEDULE33B · 3 provisions

1 Existing marketing authorisations

2 Existing applications for marketing authorisation

3 Post-authorisation processes

PART 1 The Medicines Acts 1968 and 1971 · 36 provisions

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36

PART 2 Other primary legislation · 9 provisions

37
38
39
40
41
42
43
44
45

PART 3 Northern Ireland Orders in Council · 6 provisions

PART 4 The Medicines for Human Use (Clinical Trials) Regulations 2004 · 13 provisions

52
53
54
55
56
57
58
59
60
61
62
63
64

PART 5 Other United Kingdom, Scotland and Wales Secondary legislation · 37 provisions

65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101

PART 6 Northern Ireland statutory rules · 23 provisions

102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124