- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
There are currently no known outstanding effects for the The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, PART 11 .
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
141. For regulation 187 (amendment of regulation 229 (exemption for supply by national health services bodies and local authorities)) substitute—U.K.
“187. In regulation 229(3), for sub-paragraph (f) substitute—
“(f)when the product is supplied—
(i)in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or
(ii)in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),
is in force in relation to it.”.”.
Commencement Information
I1Sch. 2 para. 141 in force at 31.12.2020 immediately before IP completion day, see reg. 1
142. For regulation 188 (amendment of regulation 230 (exemption for supply etc under a PGD to assist doctors or dentists)) substitute—U.K.
“188. For regulation 230(8) substitute—
“(8) Condition G is that when the product is supplied or (as the case may be) administered —
(a)in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or
(b)in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),
is in force in relation to it.”.”.
Commencement Information
I2Sch. 2 para. 142 in force at 31.12.2020 immediately before IP completion day, see reg. 1
143. For regulation 189 (amendment of regulation 231 (exemption for supply etc under a PGD by independent hospitals etc)) substitute—U.K.
“189. For regulation 231(8) substitute—
“(8) Condition G is that when the product is supplied—
(a)in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or
(b)in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),
is in force in relation to it.”.”.
Commencement Information
I3Sch. 2 para. 143 in force at 31.12.2020 immediately before IP completion day, see reg. 1
144. For regulation 190 (amendment of regulation 232 (exemption for supply etc under a PGD by dental practices and clinics: England and Wales)) substitute—U.K.
“190. For regulation 232(8) substitute—
“(8) Condition F is that when the product is supplied, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK) is in force in relation to it.”.”.
Commencement Information
I4Sch. 2 para. 144 in force at 31.12.2020 immediately before IP completion day, see reg. 1
145. For regulation 191 (amendment of regulation 233 (exemption for supply etc under a PGD by a person conducting a retail pharmacy business)) substitute—U.K.
“191. For regulation 233(7) substitute—
“(7) Condition F is that when the prescription only medicine is supplied or (as the case may be) administered—
(a)in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or
(b)in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),
is in force in relation to it.”.”.
Commencement Information
I5Sch. 2 para. 145 in force at 31.12.2020 immediately before IP completion day, see reg. 1
146. For regulation 192 (amendment of regulation 234 (exemption for supply etc of products under a PGD to assist the police etc)) substitute—U.K.
“192. For regulation 234(9) substitute—
“(9) Condition H is that when the product is supplied—
(a)in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), or
(b)in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),
is in force in relation to it.”.”.
Commencement Information
I6Sch. 2 para. 146 in force at 31.12.2020 immediately before IP completion day, see reg. 1
147. In regulation 193 (amendment of Schedule 17 (exemptions for sale, supply or administration by certain persons)—U.K.
(a)in paragraph (2), for “insert “ UK ” before “marketing authorisations”.” substitute “for “marketing authorisations” substitute “ UK marketing authorisations, EU marketing authorisations ”;
(b)in paragraph (3), for “insert “ UK ” before “marketing authorisation”.” substitute “for “marketing authorisation” substitute “ UK marketing authorisation, EU marketing authorisation ”.
Commencement Information
I7Sch. 2 para. 147 in force at 31.12.2020 immediately before IP completion day, see reg. 1
148. In regulation 194 (amendment of regulation 249 (restrictions on persons to be supplied with medicinal products)), for paragraphs (b) and (c) substitute—U.K.
“(b)after sub-paragraph (a) insert—
“(aa)an EU marketing authorisation;”.”;
Commencement Information
I8Sch. 2 para. 148 in force at 31.12.2020 immediately before IP completion day, see reg. 1
149. After regulation 194 (amendment of regulation 249 (restrictions on persons to be supplied with medicinal products) insert—U.K.
194A. In regulation 251 (compliance with standards specified in certain publications), after paragraph (5) insert—
“(6) In paragraph (1), (2) or (3) a product is to be treated as complying with the standard specified in the relevant monograph where—
(a)the product complies with the standard specified in a relevant marketing authorisation for the product concerned, and
(b)the standard specified in that marketing authorisation does not comply with the standard specified in the relevant monograph.
(7) In paragraph (6), “relevant marketing authorisation” means—
(a)an EU marketing authorisation;
(b)an authorisation granted by the licencing authority under Chapter 4 of Title III to the 2001 Directive; or
(c)a UKMA(GB) granted under the unfettered access route.”.”.
Commencement Information
I9Sch. 2 para. 149 in force at 31.12.2020 immediately before IP completion day, see reg. 1
150. For regulation 196 (omission of regulation 255A to 255C (enforcement and offences relating to Commission Regulation 2016/161)) substitute—U.K.
196. In regulation 255A(1), after “purpose of sale or supply,” insert “ in Northern Ireland, ”.
196A. In regulation 255B, after “medicinal products to the public” in the first place it occurs insert “ in Northern Ireland ”.”.
Commencement Information
I10Sch. 2 para. 150 in force at 31.12.2020 immediately before IP completion day, see reg. 1
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