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In force since 2025-01-01, as the publisher states.
Copy read on 2026-11-10. The page it was read from
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.
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In regulation 189 (signal detection: licensing authority obligations)— (a) in paragraph (2), for the words from the beginning to “UKMA(UK)” substitute “In relation to medicinal products subject to a UKMA(UK)(Category 2)”; (b) in paragraph (3), for the words from the beginning to “UKMA(UK)” substitute “In relation to medicinal products subject to a UKMA(UK)(Category 2)”.
Propose a changeIn regulation 190(1)(b) (signal detection: holder obligation), for “a UKMA(UK)” substitute “a UKMA(UK)(Category 2)”.
Propose a changeIn regulation 191 (obligation on holder to submit periodic safety update reports: general requirements)— (a) in paragraph (1)— (i) after “and the licensing authority” insert “in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2)”; (ii) after “UKMA(GB”) insert “or a UKMA(UK)(Category 1)”; (b) in paragraph (4A), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”; (c) in paragraph (7)— (i) after “and the licensing authority” insert “in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2)”; (ii) after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”; (d) in paragraph (8A), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”; (e) in paragraph (10)— (i) in sub-paragraph (b)(i), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (ii) in sub-paragraph (b)(ii)— (aa) after “a UKMA(GB)” insert “or a “UKMA(UK)(Category 1)”; (bb) for “Great Britain”, in both places, substitute “the United Kingdom”; (iii) in sub-paragraph (c)— (aa) in paragraph (i), in the opening words, for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (bb) in paragraph (ii), for the opening words substitute— in relation to a product authorised under a UKMA(GB) or a UKMA(UK)(Category 1), the product has been placed on the market in the United Kingdom .
Propose a changeIn regulation 192 (obligation on holder to submit periodic safety update reports: derogation from general requirements)— (a) in paragraph (3)— (i) after “and the licensing authority” insert “in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2)”; (ii) after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”; (b) in paragraph (9), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.
Propose a changeIn regulation 193 (harmonisation of PSUR frequency or date of submission)— (a) in paragraph (1)— (i) in sub-paragraph (a)(i), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (ii) in sub-paragraph (a)(ii), after “UKMA(GB)” insert “, UKMA(UK)(Category 1)”; (iii) in sub-paragraph (b)(i), after “UKMA(GB)” insert “, UKMA(UK)(Category 1)”; (iv) in sub-paragraph (b)(ii), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (b) in paragraph (2), in the opening words, for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (c) in paragraph (2A), in the opening words, after “UKMA(GB)”, insert “, UKMA(UK)(Category 1)”; (d) in paragraph (4A), after “UKMA(GB)” insert “UKMA(UK)(Category 1)”.
Propose a changeIn regulation 194(1) (responding to a single assessment of PSUR under Article 107e of the 2001 Directive), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.
Propose a changeIn regulation 195 (obligation on licensing authority to assess PSURs)— (a) in paragraph (1), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (b) in paragraph (1A), after “UKMA(GB)” insert “, UKMA(UK)(Category 1)”.
Propose a changeIn regulation 196(1) (urgent action), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.
Propose a changeIn regulation 197(1) (EU urgent action procedure), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.
Propose a changeIn regulation 198(2) (post-authorisation safety studies: general provisions)— (a) in sub-paragraph (a) for “marketing authorisation” substitute “UKMA(UK)(Category 2), UKMA(UK)(NI)”; (b) in sub-paragraph (b) for “marketing authorisation” substitute “UKMA(UK)(Category 1), a UKMA(GB)”.
Propose a changeIn regulation 199 (submission of draft study protocols for required studies)— (a) in paragraph (2)— (i) in sub-paragraph (a), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (ii) in sub-paragraph (b), after “a UKMA(GB)” insert “or UKMA(UK)(Category 1)”; (b) in paragraph (3)(b), for “in all other cases” substitute “where the study is to be conducted in the EU or an EEA State”.
Propose a changeIn regulation 200 (amendment to study protocols for required studies)— (a) in paragraph (2)— (i) in sub-paragraph (a), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (ii) in sub-paragraph (b), after “a UKMA(GB)” insert “or UKMA(UK)(Category 1)”; (b) in paragraph (3)(b), for “in all other cases” substitute “where the study is being conducted in the EU or an EEA State”.
Propose a changeIn regulation 201(2) (submission and evaluation of final study reports for required studies)— (a) in paragraph (2)— (i) in sub-paragraph (a), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (ii) in sub-paragraph (b), after “a UKMA(GB)” insert “or UKMA(UK)(Category 1)”; (b) in paragraph (3)(b), for “in all other cases” substitute “where the study was conducted in the EU or an EEA State”.
Propose a changeIn regulation 202(1) (follow-up of final study reports), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.
Propose a changeIn regulation 204(1) (obligation on licensing authority in relation to public announcements), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.
Propose a changeIn regulation 205(2) (obligations on holders in relation to public announcements), in the opening words— (a) for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (b) after “UKMA(GB)” insert “, UKMA(UK)(Category 1)”.
Propose a changeIn regulation 205A (further obligations in respect of pharmacovigilance activities)— (a) in paragraph (1), after “a UKMA(GB)” insert “, UKMA(UK)(Category 1)”; (b) in paragraph (2), omit “in respect of Great Britain”.
Propose a changeIn regulation 206 (infringement notices), in paragraph (3), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.
Propose a changeOmit regulation 210 (offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004).
Propose a changeIn regulation 210A (offences in relation to pharmacovigilance obligations under the Implementing Regulation and Schedule 12A)— (a) in paragraph (1)— (i) in sub-paragraph (a), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (ii) in sub-paragraph (aa), after “UKMA(GB)” insert “, UKMA(UK)(Category 2)”; (b) in paragraph (2A), in the opening words, for “(1)(a)” substitute “(1)(aa)”.
Propose a changeIn regulation 211 (persons liable), omit “or regulation 210(1)(a) (offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004)”.
Propose a changeIn regulation 229(3)(f)(i) (exemption for supply by NHS bodies and local authorities), omit “, EU marketing authorisation”.
Propose a changeIn regulation 230(8)(a) (exemption for supply etc. under a PGD to assist doctors or dentists), omit “, EU marketing authorisation”.
Propose a changeIn regulation 231(8)(a) (exemption for supply etc. under a PGD by independent hospitals etc), omit “, EU marketing authorisation”.
Propose a changeIn regulation 233(7)(a) (exemption for supply etc. under a PGD by person conducting a retail pharmacy business), omit “, EU marketing authorisation”.
Propose a changeIn regulation 234(9)(a) (exemption for supply etc. of products under a PGD to assist the police etc.), omit “, EU marketing authorisation”.
Propose a changeIn regulation 247A(5)(c) (protocols relating to coronavirus and influenza vaccinations and immunisations), omit the words from “or, in Northern Ireland,” to the end.
Propose a changeIn regulation 249 (restrictions on persons to be supplied with medicinal products), omit paragraph (2)(aa).
Propose a changeIn regulation 251(7) (compliance with standards specified in certain publications: definition of “relevant marketing authorisation”)— (a) omit sub-paragraph (a); (b) in sub-paragraph (c), for “UKMA(GB)” substitute “UKMA(UK)(Category 2)”.
Propose a changeOmit— (a) regulation 255A (enforcement notices relating to Commission Regulation 2016/161: persons authorised to supply medicinal products to the public); (b) regulation 255B (exception to Article 25 of Commission Regulation 2016/161: health care institutions); (c) regulation 255C (offences relating to Commission Regulation 2016/161: management of the repository system).
Propose a changeIn regulation 257 (packaging requirements: general),— (a) in paragraph (6), omit “where the product is for sale or supply in Great Britain only”; (b) in paragraph (8), omit “for sale or supply in Great Britain only”; (c) after paragraph (8) insert— (9) This regulation is subject to regulation 257AA.
Propose a changeAfter regulation 257 (packaging requirements: general), insert— Packaging requirements: variation in accordance with regulation 68(11I) 257AA. (1) This regulation applies where, in accordance with regulation 68(11I), the licensing authority thinks that a variation is necessary so that a UKMA(UK)(Category 2) is treated as a UKMA(GB) and separate UKMA(NI). (2) Where this regulation applies, the licensing authority may require that, in relation to the UKMA(GB), the information specified in paragraph 18B of Schedule 24 is replaced with a statement that the medicinal product is for sale or supply in Great Britain only. Transitional arrangements 257AB. The information specified in paragraph 18B of Schedule 24 is not required to appear on the packaging of a medicinal product released for sale or distribution before 1st January 2025, unless the product has been re-packaged or relabelled after that date. .
Propose a changeOmit regulation 257A (packaging requirements: medicinal products required to bear safety features).
Propose a changeOmit regulation 257B (transitional arrangements).
Propose a changeIn regulation 257C(1)(a) (packaging requirements: advanced therapy medicinal products), omit “for sale or supply in Great Britain only”.
Propose a changeIn regulation 257E (regulation-making power as to certain forms of labelling), omit paragraph (d).
Propose a changeIn regulation 259(2) (packaging requirements: information for blind and partially sighted patients), omit “EU marketing authorisation”.
Propose a changeIn regulation 260 (package leaflets)— (a) in paragraph (1A), omit “for sale or supply in Great Britain only”; (b) in paragraph (2), omit “for sale or supply in Great Britain only”; (c) in paragraph (3), omit “, EU marketing authorisation”.
Propose a changeIn regulation 268A(2)(a) (offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc.), omit “, Article 9 of Commission Regulation 2016/161”.
Propose a changeIn regulation 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)— (a) in paragraph (1), omit “, EU marketing authorisation”; (b) in paragraph (2)(a), omit “, Article 9 of Commission Regulation 2016/161”.
Propose a change