The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

1Citation and commencement

2Amendment of the Human Medicines Regulations 2012

3Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016

PART 2Amendment of Part 1 (General)

4Definitions in relation to advanced therapy medicinal products

5Amendment of regulation 3 (scope of Regulations: special provisions)

6Amendment of regulation 4 (special provision for pharmacies etc)

7Amendment of regulation 5 (classification of medicinal products)

8Amendment of Schedule 1 (further provisions for classification of medicinal products)

9Amendment of regulation 6 (the licensing authority and the Ministers)

10Amendment of regulation 8 (general interpretation)

11Insertion of Schedule 8B (modifications of Annex I to the 2001 Directive)

12Insertion of Schedule 2A (modifications of Commission Directive 2003/94/EC)

PART 3Amendment of Part 3 (manufacture and distribution of medicinal products and active substances)

13New regulation B17 and C17 (good manufacturing practice and good distribution practice)

14Amendment of regulation 17 (manufacturing of medicinal products)

15Amendment of regulation 18 (wholesale dealing in medicinal products)

16Insertion of new regulation 18A (approved country for import)

17Amendment of regulation 19 (exemptions from requirement for wholesale dealer's licence)

18Amendment of Schedule 3 (applications for licences under Part 3)

19Amendment of regulation 23 (grant or refusal of licence)

19AAmendment of regulation 24 (standard provisions of licences)

20Amendment of Schedule 4 (standard provisions of licences under Part 3)

21Amendment of regulation 26 (general power to suspend, revoke or vary licences)

22Amendment of Schedule 5 (review upon oral representations)

23Amendment of regulation 29 (variation of licence on the application of the holder)

24Amendment of regulation 31 (certification of manufacturer's licence)

25Amendment of regulation 33 (offence concerning data for advanced therapy medicinal products)

26Amendment of Schedule 6 (manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products)

27Amendment of regulation 36 (conditions for manufacturer's licence)

28Amendment of regulation 37 (manufacturing and assembly)

29Amendment of regulation 38 (imports)

30Amendment of regulation 39 (further requirements for manufacturer's licence)

31Amendment of regulation 42 (conditions for wholesale dealer's licence)

32Amendment of Schedule 7 (qualified persons)

33Amendment of regulation 43 (obligations of licence holder)

34Amendment of regulation 43A (requirement for wholesale dealers to decommission the unique identifier)

35Amendment of regulation 44 (requirement for wholesale dealers to deal only with specified persons)

36Amendment of regulation 45 (requirement as to responsible persons)

37Insertion of new regulations 45AA and 45AB (responsible persons: import)

38Amendment of regulation 45A (brokering in medicinal products)

39Amendment of regulation 45D (grant or refusal of a broker's registration)

40Amendment of regulation 45E (criteria of broker's registration)

41Amendment of regulation 45F (provision of information)

42Amendment of regulation 45M (criteria for importation, manufacture or distribution of an active substance)

43Amendment of Schedule 7A (information to be provided for registration as an importer, manufacturer or distributor of active substances)

44Amendment of regulation 45O (requirements for registration as an importer, manufacturer or distributor of an active substance)

PART 4Amendment of Part 4 (requirement for authorisation)

45Amendment of regulation 46 (requirement for authorisation)

46Amendment of regulation 47 (breach of requirement)

PART 5Amendment of Part 5 (marketing authorisations)

47Amendment of regulation 48 (application of Part 5)

48Amendment of regulation 49 (application for grant of UK marketing authorisation or parallel import licence)

49Amendment of regulation 50 (accompanying material)

50Amendment of Schedule 8 (material to accompany an application for a UK marketing authorisation)

51Amendment of Schedule 8A (material to accompany an application for a parallel import licence)

51AInsertion of new Schedule 8C in relation to material to accompany unfettered access applications

52Amendment of Schedule 9 (undertakings by non-United Kingdom manufacturers)

53New regulation 50A to 50J (applications in relation to particular medicinal products)

54Insertion of new Schedule in relation to orphan provisions

55Amendment of Schedule 10 (national homoeopathic products)

56Substitution of regulation 51 (applications relating to generic medicinal products)

57Substitution of regulation 52 (applications relating to certain medicinal products that do not qualify as generic etc)

58Substitution of regulation 53 (applications relating to similar biological medicinal products)

59Amendment of regulation 54 (applications relating to products in well-established medicinal use)

60Substitution of regulation 55 (applications relating to new combinations of active substances)

61Amendment of regulation 56 (applications containing information supplied in relation to another product with consent)

62Amendment of regulation 58 (consideration of application)

63Amendment of Schedule 11 (advice and representations)

64Insertion of provisions concerning consideration of certain applications for UK marketing authorisations

65Amendment of regulation 59 (conditions of UK marketing authorisation or parallel import licence: general)

66Amendment of regulation 60 (conditions of UK marketing authorisation: exceptional circumstances)

67Insertion of new regulations 60A (condition as to the submitting of samples and other information to the appropriate authority) and 60B (submitting of samples and other information: EU marketing authorisations)

68Amendment of regulation 61 (conditions of UK marketing authorisation)

69Amendment of regulation 64 (duties of licensing authority in connection with determination)

70Obligation of licensing authority in case of change of classification

71Amendment of regulation 65 (validity of UK marketing authorisation)

72Validity of conditional marketing authorisation and variation of a UK marketing authorisation

73Insertion of new Schedule 10A (variations to a UK marketing authorisation)

74Amendment of regulation 66 (application for renewal of authorisation)

75Amendment of regulation 66A (application for renewal of a parallel import licence)

76Renewal of conditional marketing authorisation

76AAmendment of regulation 67 (failure to place on the market etc.)

77Amendment of regulation 68 (revocation, variation and suspension of UK marketing authorisation or parallel import licence)

78Amendment of regulation 69 (suspension of use etc of relevant medicinal product)

79Omission of regulation 70 (authorisations granted under Chapter 4 of Title III of the 2001 Directive

80Amendment of regulation 71 (withdrawal of medicinal product from the market)

81Amendment of regulation 72 (sale etc of suspended medicinal product)

82Amendment of regulation 73 (obligation to notify placing on the market etc)

83Amendment of regulation 75 (obligation to provide information relating to safety etc)

84Amendment of regulation 76 (obligation in relation to product information)

85Amendment of regulation 77 (record-keeping obligations)

86Amendment of regulation 78 (obligation to ensure appropriate and continued supplies)

87Post authorisation requirements in relation to UK marketing authorisations with paediatric aspects and advanced therapy medicinal products

88Amendment of regulation 79 (failure to provide information on marketing authorisations to EMA)

89Amendment of regulation 80 (urgent safety restrictions)

90Application of regulations 81 to 94 (offences relating to EU marketing authorisations)

90AAmendment of regulation 89 (offences in connection with withdrawal of product from market)

90BOmission of regulation 91 (failure to notify results of third country clinical trials)

91Amendment of regulation 94A (offences relating to Commission Regulation 2016/161)

92Amendment of regulation 95 (offences in connection with application)

93Amendment of regulation 96 (provision of misleading information)

94Amendment of regulation 97 (breach of pharmacovigilance condition)

95Amendment of regulation 98 (general offence of breach of Part 5)

96Amendment of regulation 99 (penalties)

97Amendment of regulation 101 (defences)

PART 6Amendment of Part 6 (certification of homoeopathic products)

98Amendment of regulation 102 (regulation-making power to amend regulation 102(4) to (6))

99Amendment of regulation 103 (application for certificate of registration)

100Amendment of regulation 104 (consideration of application)

101Amendment of regulation 108 (application for renewal of certificate)

101AAmendment of regulation 109 (failure to place on the market etc.)

102Amendment of regulation 110 (revocation, variation and suspension of certificate of registration)

103Omission of regulation 111 (certificates granted under Chapter 4 of Title III of the 2001 Directive)

104Amendment of regulation 112 (withdrawal of homoeopathic medicinal product from the market)

105Amendment of regulation 113 (obligation to notify placing on the market etc)

106Amendment of regulation 115 (obligation to provide information relating to safety etc)

107Amendment of regulation 116 (obligation in relation to product information)

PART 7Amendment of Part 7 (Traditional Herbal Registrations)

108Amendment of italic heading above regulation 125 (traditional herbal medicinal products)

109Insertion of regulation 124A (interpretation)

110Amendment of regulation 125 (traditional herbal medicinal products)

111Insertion of regulation 125A (list of approved countries for herbal medicinal products)

112Insertion of new italic heading and regulation 126A (list of herbal substances, preparations and combinations for use in traditional herbal medicinal products)

113Amendment of regulation 127 (application for grant of traditional herbal registration)

114Amendment of regulation 128 (accompanying material)

115Amendment of Schedule 12 (material to accompany an application for a traditional herbal registration)

116Amendment of regulation 130 (consideration of application)

117Insertion of regulation 130A (procedure where less than 15 years use of traditional herbal medicinal product)

118Amendment of regulation 133 (application for renewal of registration)

118AAmendment of regulation 134 (failure to place on the market etc.)

119Amendment of regulation 135 (revocation, variation and suspension of traditional herbal registration)

120Amendment of regulation 136 (revocation by licensing authority: further provisions)

121Amendment of regulation 138 (suspension of use etc of traditional herbal medicinal product)

122Omission of regulation 139 (registrations granted under Chapter 4 of Title III of the 2001 Directive)

123Amendment of regulation 140 (withdrawal of traditional herbal medicinal product from the market)

124Amendment of regulation 141 (sale etc of suspended traditional herbal medicinal product)

125Amendment of regulation 142 (obligation to notify placing on the market etc)

126Insertion of new regulation 143A (establishment of herbal monographs)

127Substitution of regulation 144 (obligation following new herbal monograph)

128Amendment of regulation 145 (obligation to provide information relating to safety etc)

129Amendment of regulation 146 (obligation in relation to product information)

130Insertion of regulation 148A (urgent safety restrictions)

131Substitution of regulation 149 (urgent safety restrictions)

PART 8Omission of Part 8 (Article 126a authorisations)

132Amendment of regulation 156 (article 126a authorisations)

132AAmendment of regulation 157 (requests from other member States)

PART 9Amendment of Part 9 (borderline products)

133Amendment of regulation 159 (provisional determination)

134Amendment of regulation 164 (effect of determination)

PART 10Amendment of Part 10 (exceptions to requirement for marketing authorisations etc)

135ZANew regulation 135ZA (amendment of regulation 167 (supply to fulfil special patient needs))

135Amendment of regulation 168 (use of non-prescription medicines in the course of a business)

136Amendment of regulation 169 (mixing of general sale medicinal products)

137Amendment of regulation 171 (exempt advanced therapy medicinal products)

138Amendment of regulation 173 (exemption for certain radiopharmaceuticals)

PART 11Amendment of Part 11 (Pharmacovigilance)

139Amendment of regulation 177 (application of Part and interpretation)

139AAmendment of regulation 179 (obligation on licensing authority to operate pharmacovigilance system)

140Amendment of regulation 180 (obligation on licensing authority to audit pharmacovigilance system)

141Amendment of regulation 181 (delegation of obligations under Part 11)

142Amendment of regulation 182 (obligation on holder to operate a pharmacovigilance system)

143Amendment of regulation 184 (obligation on holder to audit pharmacovigilance system)

144Amendment of regulation 185 (recording obligations on the licensing authority)

145Amendment of regulation 186 (reporting obligations on the licensing authority)

146Insertion of new regulation 187A (collaboration with the World Health Organisation)

147Amendment of regulation 187 (recording obligations on holders)

148Amendment of regulation 188 (reporting obligations on holders)

149Amendment of regulation 189 (signal detection: licensing authority obligations)

150Amendment of regulation 190 (signal detection: holder obligation)

151Amendment of regulation 191 (obligation on holder to submit periodic safety update reports: general requirements)

152Amendment of regulation 192 (obligation to submit periodic safety reports: derogation from general requirements)

153Amendment of regulation 193 (harmonisation of PSUR frequency or date of submission)

154 Amendment of regulation 194 (responding to a single assessment of PSUR under Article 107e of the 2001 Directive)

155Amendment of regulation 195 (obligation on licensing authority to assess PSURs)

156ZAAmendment of regulation 196 (urgent action)

156Insertion of new regulation 196A (major safety review by the licensing authority)

157 Amendment of regulation 197 (EU urgent action procedure)

158Amendment of regulation 198 (post-authorisation safety studies: general provisions)

159Amendment of regulation 199 (submission of draft study protocols for required studies)

160Amendment of regulation 200 (amendment to study protocols for required studies)

161Amendment of regulation 201 (submission and evaluation of final study reports for required studies)

162Amendment of regulation 202 (follow up of final study reports)

163Insertion of new regulation 202A (medicinal products subject to additional monitoring)

164Amendment of regulation 203 (obligations on licensing authority in relation to national medicines web-portal)

165 Amendment of regulation 204 (obligation on licensing authority in relation to public announcements)

166Amendment of regulation 205 (obligations on holders in relation to public announcements)

167Insertion of regulation 205A (further obligations in respect of pharmacovigilance activities)

168Insertion of new Schedule 12A (further provision as to performance of pharmacovigilance activities)

169Insertion of regulation 205B (guidance in respect of good pharmacovigilance practice and post authorisation efficacy studies)

170Amendment of regulation 206 (infringement notices)

171Amendment of regulation 207 (offences)

172Amendment of regulation 208 (false and misleading information)

173Amendment of regulation 209 (penalties)

174Omission of regulation 210 (offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004)

175Amendment of regulation 210A (offences in relation to pharmacovigilance obligations under the Implementing Regulation)

176Amendment of regulation 211 (persons liable)

177Amendment of regulation 212 (transitional arrangements)

178Amendment of Schedule 33 (transitional arrangements: pharmacovigilance)

PART 12Amendment of Part 12 (dealings with medicinal products)

179Amendment of regulation 213 (interpretation of Part 12)

180Amendment of regulation 214 (sale or supply of prescription only medicines)

181Amendment of regulation 216 (exceptions to regulation 215)

182Amendment of regulation 217 (requirements for prescriptions: general)

183Amendment of regulation 217A (requirements for prescriptions to be dispensed in an EEA State)

184Amendment of regulation 218 (requirements for prescriptions: EEA health professionals)

185Amendment of regulation 219 (electronic prescriptions)

186Amendment of regulation 219A (electronic prescriptions: EEA health professionals)

187Amendment of regulation 229 (exemption for supply by national health services bodies and local authorities)

188Amendment of regulation 230 (exemption for supply etc under a PGD to assist doctors or dentists)

189Amendment of regulation 231 (exemption for supply etc under a PGD by independent hospitals etc.)

190Amendment of regulation 232 (exemption for supply etc under a PGD by dental practices and clinics: England and Wales)

191Amendment of regulation 233 (exemption for supply etc under a PGD by a person conducting a retail pharmacy business)

192Amendment of regulation 234 (exemption for supply etc of products under a PGD to assist the police etc)

193Amendment of Schedule 17 (exemptions for sale, supply or administration by certain persons)

194Amendment of regulation 249 (restrictions on persons to be supplied with medicinal products)

194AAmendment of regulation 251 (compliance with standards specified in certain publications)

195Amendment of regulation 254 (prohibitions concerning traceability of treatment with advanced therapy medicinal products)

196Amendment of regulation 255B (exception to Article 25 of Commission Regulation 2016/161: health care institutions)

196AAmendment of regulation 255B (exception to Article 25 of Commission Regulation 2016/161: health care institutions)

PART 13Omission of Part 12A (sale of medicines to the public at a distance)

197Amendment of Part 12A

PART 14Amendment of Part 13 (packaging and leaflets)

198Amendment of regulation 257 (packaging requirements: general)

199Amendment of regulation 257A (packaging requirements: medicinal products required to bear safety features)

199AAmendment of regulation 257B (transitional arrangements)

200Insertion of regulations 257C (packaging requirements: advanced therapy medicinal products) and 257D and 257E (guidance and regulations in relation to packing, leaflets and labelling)

201Amendment of Schedule 24 (packaging information requirements)

202Amendment of regulation 259 (packaging requirements: information for blind and partially sighted patients)

203Amendment of regulation 260 (package leaflets)

204Amendment of Schedule 27 (package leaflets)

205Amendment of regulation 266 (language requirements etc)

206Amendment of regulation 267 (submission of mock-ups of packaging and leaflets to licensing authority)

207Amendment of regulation 268 (offence relating to packaging and package leaflets)

207AInsertion of new regulation 268A (offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc)

208Amendment of regulation 269 (offences relating to packaging and package leaflets: other persons)

208AInsertion of new regulation 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)

209Amendment of regulation 270 (non-compliance with requirements of this Part)

209AAmendment of regulation 271 (offences: penalties)

210Amendment of regulation 273 (child resistant containers for regulated medicinal products)

PART 15Amendment of Part 14 (advertising)

211Amendment of regulation 279 (products without a marketing authorisation)

212Amendment of regulation 280 (general principles)

213Amendment of regulation 281 (duties of authorisation holders and registration holders)

213AInsertion of new regulation 284A (Medicines with differing classification status in Great Britain and Northern Ireland)

214Amendment of regulation 293 (prohibition of supply to the public for promotional purposes)

214AAmendment of regulation 294 (general requirements)

215Amendment of regulation 295 (abbreviated advertisements)

215AAmendment of regulation 298 (free samples for persons qualified to prescribe or supply medicinal products)

216Amendment of Schedule 30 (particulars for advertisements to persons qualified to prescribe or supply)

217Amendment of regulation 299 (medical sales representatives)

217AAmendment of regulation 305 (invitation to make representations about compatibility)

217BAmendment of regulation 306 (decision about compatibility)

217CAmendment of regulation 307 (corrective statement)

217DAmendment of regulation 311 (application for injunction)

PART 16Amendment of Part 15 (British Pharmacopoeia)

218Amendment of regulation 321 (specified publications)

PART 17Amendment of Part 16 (enforcement)

219Amendment of regulation 322 (validity of proceedings)

220Amendment of regulation 323 (enforcement in England, Wales and Scotland)

221Amendment of regulation 327 (powers of inspection, sampling and seizure)

222Amendment of regulation 331 (findings and reports of inspections)

223Insertion of regulation 331A (guidelines on inspections)

PART 18Amendment of Part 17 (miscellaneous and general)

224ZAAmendment of regulation 335 (contravention due to fault of another person)

224ZBAmendment of regulation 336 (warranty as defence)

224ZCAmendment of regulation 340 (presumptions)

224ZDAmendment of Schedule 32 (transitional provisions and savings)

224Amendment of regulation 341 (decisions under the Human Medicines Regulations 2012)

225Insertion of regulation 344A (modifications to deal with serious shortages) and 344B (regulation making powers)

226Amendment of regulation 345 (immunity from civil liability)

227Amendment of regulation 346 (Secretary of State to carry out a review of certain provisions)

PART 19Transitional and consequential provision and revocations

228Transitional provision in relation to EU exit

229Consequential amendments

230Revocations of retained direct EU law

SCHEDULE 1Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016

1ZAInsertion of new regulation 10A (waiver for advice given to small and medium companies)

1Amendment of regulation 19 (capital fees for applications for variations of authorisations)

2Insertion of regulations 19A-19F (fees for plasma master files, vaccine antigen master files, post-authorisation safety studies, major safety reviews, periodic safety update reports and batch testing)

3Amendment of regulation 23 (applications for multiple variations)

4Insertion of regulation 27A (fee for renewals of a marketing authorisation)

5Omission of Part 8 (Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorisations)

6Amendment of Schedule 1 (general interpretation provisions)

7Amendment of Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates)

8Amendment of Schedule 4 (periodic fees for licences)

8AAmendment of Schedule 6 (time for payment of capital fees: small companies)

9Amendment of Schedule 7 (waiver, reduction or refund of capital fees)

10Amendment of Schedule 8 (Adjustment, reduction or refund of periodic fees)

SCHEDULE 2Insertion of new Schedule 8B (modifications of Annex I to the 2001 Directive)

1After Schedule 8A to the Human Medicines Regulations 2012, insert—...

SCHEDULE 2AInsertion of new Schedule 8C (Material to accompany an application for a UK marketing authorisation under the unfettered access route)

1After Schedule 8B to the Human Medicines Regulations 2012, insert—...

SCHEDULE 3Insertion of new Schedule 2A (modifications of Commission Directive 2003/94/EC)

1After Schedule 2 to the Human Medicines Regulations 2012, insert—...

SCHEDULE 4Insertion of new Schedule 9A

1After Schedule 9, insert— SCHEDULE 9A Meaning of terms used...

SCHEDULE 5Insertion of new Schedule 10A (variations to a UK marketing authorisation)

1After Schedule 10, insert— SCHEDULE 10A Variations to a UK marketing...

SCHEDULE 6Insertion of new Schedule 12A (further provision as to the performance of pharmacovigilance activities)

1After Schedule 12 insert— SCHEDULE 12A Further provision as to the...

SCHEDULE 7Insertion of new Schedule 33A (transitional provision)

1After Schedule 33 insert— SCHEDULE 33A Transitional provision in relation to...

SCHEDULE 8Consequential provision

PART 1Amendment of primary legislation

1Amendment of the National Health Service Act 2006

2Amendment of the Access to Medical Treatments (Innovation) Act 2016

PART 2Amendment of secondary legislation

3Amendment of the Medicines (Bal Jivan Chamcho Prohibition) (No 2) Order 1977

4Amendment of the Prescription Only Medicines (Human Use) Order 1997

5Amendment of the Medicines (Aristolochia and Mu Tong etc) (Prohibition) Order 2001

6Amendment of the Medicines for Human Use (Kava-kava) (Prohibition) Order 2002

7Amendment of the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003

8Amendment of the Blood Safety and Quality Regulations 2005

9Amendment of the Natural Mineral Water, Spring Water and Bottled Drinking Water (England) Regulations 2007

10Amendment of the Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008

11Amendment of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

12Amendment of the Genetically Modified Organisms (Contained Use) Regulations 2014

13Amendment of the Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015

14Amendment of the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015

15Amendment of the Health Service Products (Provision and Disclosure of Information) Regulations 2018

16Amendment of the Branded Health Service Medicines (Costs) Regulations 2018

SCHEDULE 9Retained EU law: revocations

1Insofar as they apply to medicinal products for human use,...

2019 No. 775

Exiting The European Union

Medicines

The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Made1st April 2019

Coming into force in accordance with regulation 1

The Secretary of State makes these Regulations in exercise of the powers conferred by section 8(1) of, and paragraphs 1(1) and 7(2) of Schedule 4 and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018 M1.

The Treasury has consented to the making of these Regulations as required by paragraphs 3(1) and 10 of Schedule 4 to the European Union (Withdrawal) Act 2018.

In accordance with paragraphs 1(1) and 12(1) of Schedule 7 to the European Union (Withdrawal) Act 2018, a draft of these Regulations has been laid before and approved by a resolution of each House of Parliament.