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There are currently no known outstanding effects for the The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020.
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2.Amendment of the Good Laboratory Practice Regulations 1999Previous MatchNext Match
3.Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019Previous MatchNext Match
4.Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019Previous MatchNext Match
5.Amendment of the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Previous MatchNext Match
SCHEDULES
SCHEDULE 1Previous MatchNext Match
Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019Previous MatchNext Match
1.Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019Previous MatchNext Match
2.In regulation 7 (amendment of regulation 13 (supply of investigational...Previous MatchNext Match
3.For regulation 17 (amendment of regulation 36 (requirement for authorisation...Previous MatchNext Match
4.For regulation 18 (amendment of regulation 43 (qualified persons)) substitute—...Previous MatchNext Match
5.In regulation 19 (insertion of regulation 43A (approved country for...Previous MatchNext Match
6.In regulation 20 (amendment of regulation 45 (suspension and revocation...Previous MatchNext Match
7.In regulation 23 (insertion of regulation 57 (functions in relation...Previous MatchNext Match
8.In regulation 24 (amendment of Schedule 3 (particulars and documents...Previous MatchNext Match
9.For regulation 25 (amendment of Schedule 7 (standard provisions for...Previous MatchNext Match
10.In regulation 26 (insertion of Schedule 13 (transitional provisions in...Previous MatchNext Match
SCHEDULE 2Previous MatchNext Match
Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019Previous MatchNext Match
PART 1 Amendment of Part 2 (amendment of Part 1 (General))Previous MatchNext Match
1.In regulation 4 (definitions in relation to advanced therapy medicinal...Previous MatchNext Match
2.In regulation 5 (amendment of regulation 3 (scope of Regulations:...Previous MatchNext Match
3.In regulation 6 (amendment of regulation 4 (special provision for...Previous MatchNext Match
4.In regulation 7 (amendment of regulation 5 (classification of medicinal...Previous MatchNext Match
5.For regulation 8 (amendment of Schedule 1 (further provisions for...Previous MatchNext Match
6.Omit regulation 9 (amendment of regulation 6 (the licensing authority...Previous MatchNext Match
7.In regulation 10 (amendment of regulation 8 (general interpretation))— Previous MatchNext Match
PART 2 Amendment of Part 3 (amendment of Part 3 (manufacture and distribution of medicinal products and active substances))Previous MatchNext Match
8.In regulation 13 (new regulation B17 and C17 (good manufacturing...Previous MatchNext Match
9.In regulation 14 (amendment of regulation 17 (manufacturing of medicinal...Previous MatchNext Match
10.In regulation 15 (amendment of regulation 18 (wholesale dealing in...Previous MatchNext Match
11.In regulation 17 (amendment of regulation 19 (exemptions from requirement...Previous MatchNext Match
12.In regulation 18 (amendment of Schedule 3 (applications for licences...Previous MatchNext Match
13.After regulation 19 (amendment of regulation 23 (grant or refusal...Previous MatchNext Match
14.In regulation 20 (amendment of Schedule 4 (standard provisions of...Previous MatchNext Match
15.For regulation 21 (amendment of regulation 26 (general power to...Previous MatchNext Match
16.In regulation 24 (amendment of regulation 31 (certification of manufacturer's...Previous MatchNext Match
17.In regulation 27 (amendment of regulation 36 (conditions for manufacturer's...Previous MatchNext Match
18.In regulation 28 (amendment of regulation 37 (manufacturing and assembly))—...Previous MatchNext Match
19.In regulation 29 (amendment of regulation 38 (imports))— Previous MatchNext Match
20.In regulation 30 (amendment of regulation 39 (further requirements for...Previous MatchNext Match
21.In regulation 31 (amendment of regulation 42 (conditions for wholesale...Previous MatchNext Match
22.In regulation 32 (amendment of Schedule 7 (qualified persons))— Previous MatchNext Match
23.In regulation 33 (amendment of regulation 43 (obligations of licence...Previous MatchNext Match
24.For regulation 34 (omission of regulation 43A (requirement for wholesale...Previous MatchNext Match
25.In regulation 35 (amendment of regulation 44 (requirement for wholesale...Previous MatchNext Match
26.In regulation 36 (amendment of regulation 45 (requirement as to...Previous MatchNext Match
27.In regulation 37 (insertion of new regulations 45AA and 45AB...Previous MatchNext Match
28.In regulation 38 (amendment of regulation 45A (brokering in medicinal...Previous MatchNext Match
29.In regulation 40 (amendment of regulation 45E (criteria of broker's...Previous MatchNext Match
30.In regulation 41 (amendment of regulation 45F (provision of information)),...Previous MatchNext Match
31.In regulation 42 (amendment of regulation 45M (criteria for importation,...Previous MatchNext Match
32.In regulation 44 (amendment of regulation 45O (requirements for registration...Previous MatchNext Match
PART 3 Amendment of Part 4 (amendment of Part 4 (requirement for authorisation))Previous MatchNext Match
PART 4 Amendment of Part 5 (amendment of Part 5 (marketing authorisations))Previous MatchNext Match
35.In regulation 47 (amendment of regulation 48 (application of Part...Previous MatchNext Match
36.In regulation 48 (amendment of regulation 49 (application for grant...Previous MatchNext Match
37.In regulation 49 (amendment of regulation 50 (accompanying material))— Previous MatchNext Match
38.In regulation 50 (amendment of Schedule 8 (material to accompany...Previous MatchNext Match
39.After regulation 51 (amendment of Schedule 8A (material to accompany...Previous MatchNext Match
40.In regulation 53 (new regulation 50A to 50J (applications in...Previous MatchNext Match
41.For regulation 56 (substitution of regulation 51 (applications relating to...Previous MatchNext Match
42.For regulation 57 (amendment of regulation 52 (applications relating to...Previous MatchNext Match
43.For regulation 58 (amendment of regulation 53 (applications relating to...Previous MatchNext Match
44.For regulation 60 (amendment of regulation 55 (applications relating to...Previous MatchNext Match
45.In regulation 62 (amendment of regulation 58 (consideration of application))—...Previous MatchNext Match
46.In regulation 63 (amendment of Schedule 11 (advice and representations))—...Previous MatchNext Match
47.In regulation 64 (insertion of provisions concerning consideration of certain...Previous MatchNext Match
48.In regulation 65 (amendment of regulation 59 (conditions of UK...Previous MatchNext Match
49.For regulation 66 (amendment of regulation 60 (conditions of UK...Previous MatchNext Match
50.In regulation 67 (insertion of new regulations 60A (condition as...Previous MatchNext Match
51.In regulation 68 (amendment of regulation 61 (conditions of UK...Previous MatchNext Match
52.For regulation 69 (amendment of regulation 64 (duties of licensing...Previous MatchNext Match
53.In regulation 70 (obligation of licensing authority in case of...Previous MatchNext Match
54.In regulation 72 (validity of conditional marketing authorisation and variation...Previous MatchNext Match
55.In regulation 74 (amendment of regulation 66 (application for renewal...Previous MatchNext Match
56.After regulation 76 (renewal of conditional marketing authorisation) insert— Amendment...Previous MatchNext Match
57.In regulation 77 (amendment of regulation 68 (revocation, variation and...Previous MatchNext Match
58.In regulation 80(2) (amendment of regulation 71 (withdrawal of medicinal...Previous MatchNext Match
59.For regulation 81 (amendment of regulation 72 (sale etc of...Previous MatchNext Match
60.In regulation 82 (amendment of regulation 73 (obligation to notify...Previous MatchNext Match
61.For regulation 84 (amendment of regulation 76 (obligation in relation...Previous MatchNext Match
62.Omit regulation 85 (amendment of regulation 77 (record-keeping obligations)). Previous MatchNext Match
63.Omit regulation 86 (amendment of regulation 78 (obligation to ensure...Previous MatchNext Match
64.In regulation 87 (post authorisation requirements in relation to UK...Previous MatchNext Match
65.For regulation 88 (omission of regulation 79 (failure to provide...Previous MatchNext Match
66.In regulation 89 (amendment of regulation 80 (urgent safety restrictions))—...Previous MatchNext Match
67.For regulation 90 (omission of regulations 81 to 94 (offences...Previous MatchNext Match
68.For regulation 91 (omission of regulation 94A (offences relating to...Previous MatchNext Match
69.For regulation 92 (amendment of regulation 95 (offences in connection...Previous MatchNext Match
70.Omit regulation 93 (amendment of regulation 96 (provision of misleading...Previous MatchNext Match
71.In regulation 94 (amendment of regulation 97 (breach of pharmacovigilance...Previous MatchNext Match
72.Omit regulation 95 (amendment of regulation 98 (general offence of...Previous MatchNext Match
73.Omit regulation 96 (amendment of regulation 99 (penalties)). Previous MatchNext Match
74.Omit regulation 97 (amendment of regulation 101 (defences)). Previous MatchNext Match
75.In regulation 98 (amendment of regulation 102 (regulation-making power to...Previous MatchNext Match
76.In regulation 99 (amendment of regulation 103 (application for certificate...Previous MatchNext Match
77.For regulation 100 (amendment of regulation 104 (consideration of application))...Previous MatchNext Match
78.In regulation 101 (amendment of regulation 108 (application for renewal...Previous MatchNext Match
79.After regulation 101 (amendment of regulation 108 (application for renewal...Previous MatchNext Match
PART 5 Amendment of Part 6 (amendment of Part 6 (certification of homoeopathic products))Previous MatchNext Match
PART 6 Amendment of Part 7 (amendment of Part 7 (Traditional Herbal Registrations))Previous MatchNext Match
82.In regulation 110 (amendment of regulation 125 (traditional herbal medicinal...Previous MatchNext Match
83.In regulation 112 (insertion of new italic heading and regulation...Previous MatchNext Match
84.For regulation 113 (amendment of regulation 127 (application for grant...Previous MatchNext Match
85.For regulation 114 (amendment of regulation 128 (accompanying material)) substitute—...Previous MatchNext Match
86.For regulation 115(3)(a) (amendment of Schedule 12 (material to accompany...Previous MatchNext Match
87.In regulation 116 (amendment of regulation 130 (consideration of application))—...Previous MatchNext Match
88.In regulation 117 (Insertion of regulation 130A (procedure where less...Previous MatchNext Match
89.In regulation 118 (amendment of regulation 133 (application for renewal...Previous MatchNext Match
90.After regulation 118 amendment of regulation 133 (amendment of regulation...Previous MatchNext Match
91.In regulation 119 (amendment of regulation 135 (revocation, variation and...Previous MatchNext Match
92.In regulation 120(2) (amendment of regulation 136 (revocation by licensing...Previous MatchNext Match
93.In regulation 123 (amendment of regulation 140 (withdrawal of traditional...Previous MatchNext Match
94.In regulation 125 (amendment of regulation 142 (obligation to notify...Previous MatchNext Match
95.In regulation 126 (insertion of new regulation 143A (establishment of...Previous MatchNext Match
96.For regulation 127 (amendment of regulation 144 (obligation following new...Previous MatchNext Match
97.For regulation 129 (amendment of regulation 146 (obligation in relation...Previous MatchNext Match
98.In regulation 131 (amendment of regulation 149 (urgent safety restrictions))...Previous MatchNext Match
PART 7 Amendment of Part 8 (omission of Part 8 (Article 126a authorisations))Previous MatchNext Match
PART 8 Amendment of Part 9 (amendment of Part 9 (borderline products))Previous MatchNext Match
PART 9 Amendment of Part 10 (amendment of Part 10 (exceptions to requirement for marketing authorisations etc))Previous MatchNext Match
102.Before regulation 135 (amendment of regulation 168 (use of non-prescription...Previous MatchNext Match
103.For regulation 135 (amendment of regulation 168 (use of non-prescription...Previous MatchNext Match
104.In regulation 136 (amendment of regulation 169 (mixing of general...Previous MatchNext Match
105.In regulation 137 (amendment of regulation 171 (exempt advanced therapy...Previous MatchNext Match
106.In regulation 138 (amendment of regulation 173 (exemption for certain...Previous MatchNext Match
PART 10 Amendment of Part 11 (amendment of Part 11 (Pharmacovigilance))Previous MatchNext Match
107.In regulation 139 (amendment of regulation 177 (application of part...Previous MatchNext Match
108.After regulation 139 (amendment of regulation 177 (application of part...Previous MatchNext Match
109.In regulation 140 (amendment of regulation 180 (obligation on licensing...Previous MatchNext Match
110.For regulation 141 (omission of regulation 181 (delegation of obligations...Previous MatchNext Match
111.In regulation 142 (amendment of regulation 182 (obligation on holder...Previous MatchNext Match
112.In regulation 143 (amendment of regulation 184 (obligation on holder...Previous MatchNext Match
113.For regulation 145 (amendment of regulation 186 (reporting obligations on...Previous MatchNext Match
114.In regulation 147 (amendment of regulation 187 (recording obligations on...Previous MatchNext Match
115.In regulation 148 (amendment of regulation 188 (reporting obligations on...Previous MatchNext Match
116.In regulation 149 (amendment of regulation 189 (signal detection: licensing...Previous MatchNext Match
117.For regulation 150 (amendment of regulation 190 (signal detection: holder...Previous MatchNext Match
118.In regulation 151 (amendment of regulation 191 (obligation on holder...Previous MatchNext Match
119.In regulation 152 (amendment of regulation 192 (obligation to submit...Previous MatchNext Match
120.In regulation 153 (amendment of regulation 193 (harmonisation of PSUR...Previous MatchNext Match
121.In regulation 154 (omission of regulation 194 (responding to a...Previous MatchNext Match
122.In regulation 155 (amendment of regulation 195 (obligation on licensing...Previous MatchNext Match
123.Before regulation 156 insert— Amendment of regulation 196 (urgent action)...Previous MatchNext Match
124.In regulation 156 (substitution of regulation 196 (urgent action))— Previous MatchNext Match
125.In regulation 157 (omission of regulation 197 (EU urgent action...Previous MatchNext Match
126.In regulation 158 (amendment of regulation 198 (post-authorisation safety studies:...Previous MatchNext Match
127.In regulation 159 (amendment of regulation 199 (submission of draft...Previous MatchNext Match
128.In regulation 160 (amendment of regulation 200 (amendment to study...Previous MatchNext Match
129.In regulation 161 (amendment of regulation 201 (submission and evaluation...Previous MatchNext Match
130.For regulation 162 (omission of regulation 202 (follow up of...Previous MatchNext Match
131.For regulation 164(3) (amendment of regulation 203 (obligations on licensing...Previous MatchNext Match
132.In regulation 165 (omission of regulation 204 (obligation on licensing...Previous MatchNext Match
133.In regulation 166 (amendment of regulation 205 (obligations on holders...Previous MatchNext Match
134.In regulation 167 (insertion of regulation 205A (further obligations in...Previous MatchNext Match
135.In regulation 170 (amendment of regulation 206 (infringement notices)) for...Previous MatchNext Match
136.Omit regulations 172 (amendment regulation 208 (false and misleading information)),...Previous MatchNext Match
137.In regulation 175 (amendment of regulation 210A (offences in relation...Previous MatchNext Match
138.Omit regulation 176 (amendment of regulation 211 (persons liable)). Previous MatchNext Match
139.For regulation 177 (amendment of regulation 212 (transitional amendments)) substitute—...Previous MatchNext Match
140.In regulation 178 (amendment of Schedule 33 (transitional arrangements: pharmacovigilance))...Previous MatchNext Match
PART 11 Amendment of Part 12 (amendment of Part 12 (dealings with medicinal products))Previous MatchNext Match
141.For regulation 187 (amendment of regulation 229 (exemption for supply...Previous MatchNext Match
142.For regulation 188 (amendment of regulation 230 (exemption for supply...Previous MatchNext Match
143.For regulation 189 (amendment of regulation 231 (exemption for supply...Previous MatchNext Match
144.For regulation 190 (amendment of regulation 232 (exemption for supply...Previous MatchNext Match
145.For regulation 191 (amendment of regulation 233 (exemption for supply...Previous MatchNext Match
146.For regulation 192 (amendment of regulation 234 (exemption for supply...Previous MatchNext Match
147.In regulation 193 (amendment of Schedule 17 (exemptions for sale,...Previous MatchNext Match
148.In regulation 194 (amendment of regulation 249 (restrictions on persons...Previous MatchNext Match
149.After regulation 194 (amendment of regulation 249 (restrictions on persons...Previous MatchNext Match
150.For regulation 196 (omission of regulation 255A to 255C (enforcement...Previous MatchNext Match
PART 12 Amendment of Part 13 (omission of Part 12A (sale of medicines to the public at a distance))Previous MatchNext Match
PART 13 Amendment of Part 14 (amendment of Part 13 (packaging and leaflets))Previous MatchNext Match
152.In regulation 198 (amendment of regulation 257 (packaging requirements: general))—...Previous MatchNext Match
153.For regulation 199 (omission of regulations 257A and 257B (packaging...Previous MatchNext Match
154.In regulation 200 (insertion of regulations 257C (packaging requirements: advanced...Previous MatchNext Match
155.In regulation 201 (amendment of Schedule 24 (packaging information requirements))—...Previous MatchNext Match
156.In regulation 202 (amendment of regulation 259 (packaging requirements: information...Previous MatchNext Match
157.In regulation 203 (amendment of regulation 260 (package leaflets))— Previous MatchNext Match
158.In regulation 204 (amendment of Schedule 27 (package leaflets))— Previous MatchNext Match
159.Omit regulation 205 (amendment of regulation 266 (language requirements etc))....Previous MatchNext Match
160.In regulation 206 (amendment of regulation 267 (submission of mock-ups...Previous MatchNext Match
161.In regulation 207 (amendment of regulation 268 (offence relating to...Previous MatchNext Match
162.After regulation 207 (amendment of regulation 268 (offence relating to...Previous MatchNext Match
163.In regulation 208 (amendment of regulation 269 (offences relating to...Previous MatchNext Match
164.After regulation 208 (amendment of regulation 269 (offences relating to...Previous MatchNext Match
165.In regulation 209 (amendment of regulation 270 (non-compliance with requirements...Previous MatchNext Match
166.After regulation 209 (amendment of regulation 270 (non-compliance with requirements...Previous MatchNext Match
PART 14 Amendment of Part 15 (amendment of Part 14 (advertising))Previous MatchNext Match
167.For regulation 211 (amendment of regulation 279 (products without a...Previous MatchNext Match
168.In regulation 212 (amendment of regulation 280 (general principles))— Previous MatchNext Match
169.In regulation 213 (amendment of regulation 281 (duties of authorisation...Previous MatchNext Match
170.After regulation 213 (amendment of regulation 281 (duties of authorisation...Previous MatchNext Match
171.For regulation 214 (amendment of regulation 293 (prohibition of supply...Previous MatchNext Match
172.After regulation 214 (amendment of regulation 293 (prohibition of supply...Previous MatchNext Match
173.For regulation 215 (amendment of regulation 295 (abbreviated advertisements)) substitute—...Previous MatchNext Match
174.After regulation 215 (amendment of regulation 295 (abbreviated advertisements)) insert—...Previous MatchNext Match
175.For regulation 216 (amendment of Schedule 30 (particulars for advertisements...Previous MatchNext Match
176.In regulation 217 (amendment of regulation 299 (medical sales representatives)),...Previous MatchNext Match
177.After regulation 217 (amendment of regulation 299 (medical sales representatives))...Previous MatchNext Match
PART 15 Amendment of Part 16 (amendment of Part 15 (British Pharmacopoeia))Previous MatchNext Match
PART 16 Amendment of Part 17 (amendment of Part 16 (enforcement))Previous MatchNext Match
179.Omit regulation 219 (amendment of regulation 322 (validity of proceedings))....Previous MatchNext Match
180.In regulation 221 (amendment of regulation 327 (powers of inspection,...Previous MatchNext Match
181.In regulation 222 (amendment of regulation 331 (findings and reports...Previous MatchNext Match
182.In regulation 223 (insertion of regulation 331A (guidelines on inspections)),...Previous MatchNext Match
PART 17 Amendment of Part 18 (amendment of Part 17 (miscellaneous and general))Previous MatchNext Match
183.Before regulation 224 (amendment of regulation 341 (decisions under the...Previous MatchNext Match
184.For regulation 224 (amendment of regulation 341 (decisions under the...Previous MatchNext Match
185.In regulation 225 (insertion of regulation 344A (modifications to deal...Previous MatchNext Match
186.For regulation 226 (amendment of regulation 345 (immunity from civil...Previous MatchNext Match
187.In regulation 227 (amendment of regulation 346 (Secretary of State...Previous MatchNext Match
PART 18 Amendment of Schedule 1 (amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016)Previous MatchNext Match
PART 19 Insertion of Schedule 2A (insertion of new Schedule 8C (material to accompany an application for a UK marketing authorisation under the unfettered access route))Previous MatchNext Match
PART 20 Amendment of Schedule 4 (insertion of new Schedule 9A)Previous MatchNext Match
PART 21 Amendment of Schedule 6 (insertion of new Schedule 12A (further provision as to the performance of pharmacovigilance activities))Previous MatchNext Match
PART 22 Amendment of Schedule 7 (insertion of new Schedule 33A (Transitional Provision))Previous MatchNext Match
PART 23 Amendment of Schedule 8 (consequential provision)Previous MatchNext Match
PART 24 Amendment of Schedule 9 (retained EU law: revocations)Previous MatchNext Match
SCHEDULE 3Previous MatchNext Match
Amendment of the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019Previous MatchNext Match
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