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The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024

United Kingdom · regulation

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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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Contents: 147 provisions

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147 provisions

120 Amendment to regulation 270

In regulation 270 (non-compliance with requirements of Part)— (a) in paragraph (1), omit “, EU marketing authorisation”; (b) in paragraph (2), omit “, EU marketing authorisation”.

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121 Amendment to regulation 279

In regulation 279 (products without a marketing authorisation etc.)— (a) insert “or” at the end of paragraph (2)(c); (b) omit paragraph (2)(d) (including the “or” at the end).

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122 Amendment to regulation 280

In regulation 280(1) (general principles), omit “, EU marketing authorisation”.

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123 Amendment to regulation 281

In regulation 281(1) (duties of authorisation holders and registration holders)— (a) insert “or” at the end of sub-paragraph (c); (b) omit sub-paragraph (e) and the “or” which precedes it.

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124 Amendment to regulation 293

In regulation 293(1)(b) (prohibition of supply to the public for promotional purposes), omit “, EU marketing authorisation”.

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125 Amendment to regulation 295

In regulation 295(2)(d)(ii) (abbreviated advertisements), omit “, EU marketing authorisation,”.

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126 Amendment to regulation 299

In regulation 299(3) (medical sales representatives), omit “EU marketing authorisation”.

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127 Amendment to regulation 321

In regulation 321(5) (specified publications: definition of “authorisation”), omit sub-paragraph (ca).

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128 Amendment to regulation 327

In regulation 327 (powers of inspection, sampling and seizure)— (a) omit paragraph (1)(c)(va); (b) omit paragraph (2)(h); (c) omit paragraph (4A); (d) in paragraph (5)— (i) in sub-paragraph (a), for “, (g) or (h)” substitute “or (g)”; (ii) in sub-paragraph (b), omit “or (4A)”.

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129 Amendment to regulation 331

In regulation 331(1) (findings and reports of inspections)— (a) in the opening words, omit “, EU marketing authorisation”; (b) in sub-paragraph (c), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.

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130 Amendment to regulation 341

In regulation 341(4) (decisions under the Regulations), omit sub-paragraph (aa).

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131 Amendment to regulation 345

In regulation 345(5) (immunity from civil liability), omit “, EU marketing authorisation”.

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132 Amendment to regulation 346

In regulation 346(2) (review)— (a) in sub-paragraph (c)(iv), for “(10)” substitute “(12)”; (b) omit sub-paragraph(c)(iia), (iiia), (iva), (xviia), (xviii), (xix), (xxviiii) and (xxviiij).

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133 Insertion of regulation 347B

After regulation 347A (transitional provision in relation to EU exit), insert— Transitional provision relating to the Windsor Framework 347B. (1) Schedule 33B contains transitional provision in relation to the implementation of the Windsor Framework. (2) In paragraph (1), “the Windsor Framework” means the part of the withdrawal agreement known as the Windsor Framework by virtue of Joint Declaration No. 1/2023 of 24 March 2023 made between the European Union and the United Kingdom in the Joint Committee established by the withdrawal agreement. .

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134 Amendment to Schedule 1

In Schedule 1 (further provisions for classification of medicinal products)— (a) in paragraph 1— (i) in sub-paragraph (e)(i), omit “, EU marketing authorisation”; (ii) in sub-paragraph (f)(i), omit “, EU marketing authorisation”; (iii) in sub-paragraph (g)(i), omit “, EU marketing authorisation”; (b) in paragraph 4, omit “, EU marketing authorisation”.

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135 Amendment to Schedule 7

In Schedule 7 (qualified persons), in paragraph 12A(1)— (a) at the end of paragraph (b), for “; and” substitute a full stop; (b) omit paragraph (c).

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136 Amendment to Schedule 7A

In Schedule 7A (information to be provided for registration), in paragraph 15, omit sub-paragraph (a).

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137 Amendment to Schedule 8

In Schedule 8 (material to accompany an application for a UK marketing authorisation)— (a) in paragraph 18— (i) omit sub-paragraph (a); (ii) in sub-paragraph (b), omit “in the case of a medicinal product for sale or supply in Great Britain,”; (b) in paragraph 23— (i) in sub-paragraph (a), for “medicinal product for sale or supply in Northern Ireland” substitute “UKMA(NI) or a UKMA(UK)(Category 2)”; (ii) in sub-paragraph (b), for “medicinal product for sale or supply in Great Britain” substitute “UKMA(GB) or a UKMA(UK)(Category 1)”; (c) in paragraph 25A, omit “for sale or supply in Great Britain”.

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138 Amendment to Schedule 8C

In Schedule 8C (material to accompany an application under the unfettered access route)— (a) in paragraph 1, omit “EU marketing authorisation or”; (b) in paragraph 2, omit “EU marketing authorisation or”; (c) in paragraph 3, omit “EU marketing authorisation or”.

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139 Amendment to Schedule 9A

In Schedule 9A (meaning of terms used in the orphan criteria and in regulation 58D), in each of the following provisions, for “Great Britain” substitute “the United Kingdom”— (a) the heading of paragraph (1); (b) paragraph 1(1), 1(2)(a) and (c); (c) paragraph 2(1), 2(2)(c), (d), (g) and (h); (d) paragraph 3(1) and 3(2)(a) in both places.

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140 Amendment to Schedule 12A

In Schedule 12A (further provision as to the performance of pharmacovigilance activities)— (a) in paragraph 1(3), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”; (b) in paragraph 12(5), after “UKMA(GB)” insert “or the UKMA(UK)(Category 1), as the case may be,”; (c) in paragraph 16(3), after “UKMA(GB)” insert “or the UKMA(UK)(Category 1), as the case may be,”; (d) in paragraph 22(1)(d), after “UKMA(GB)” insert “or the UKMA(UK)(Category 1)”; (e) in paragraph 30(g), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”.

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141 Amendment to Schedule 17

In Schedule 17 (exemption for sale, supply or administration by certain persons)— (a) in the table in Part 1, in column 1 in entry 10, omit “EU marketing authorisations”; (b) in the table in Part 4, in columns 1 and 2 in entry 9, omit “EU marketing authorisation”.

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142 Amendment to Schedule 24

In Schedule 24 (packaging information requirements)— (a) in paragraph 7(b), omit the words from “in the case of products for sale or supply in Great Britain” to the end; (b) in paragraph 15, omit “EU marketing authorisation”; (c) in paragraph 16, omit “EU marketing authorisation”; (d) omit paragraph 18A; (e) at the end of Part 1, insert— 18B. The words “UK only”. ; (f) in paragraph 23, omit “EU marketing authorisation”; (g) in the heading to Part 4, omit “for sale or supply in Great Britain only”; (h) in the heading to Part 5, omit “for sale or supply in Great Britain only”.

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143 Amendment to Schedule 27

In Schedule 27 (package leaflets)— (a) in paragraph 8(c)(ii), omit the words from “in the case of products for sale or supply in Great Britain” to the end; (b) in paragraph 11(f), omit “, EU marketing authorisation”; (c) in the heading to Part 3, omit “for sale or supply in Great Britain only”.

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144 Amendment to Schedule 30

In Schedule 30 (particulars for advertisements to persons qualified to prescribe or supply)— (a) in paragraph 1, omit “, EU marketing authorisation”; (b) in paragraph 2, omit “, EU marketing authorisation”; (c) in paragraph 6, omit “, EU marketing authorisation”.

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145 Amendment to Schedule 33A

In Schedule 33A (transitional provision in relation to EU Exit), omit paragraph 29A.

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146 Insertion of Schedule 33B

After Schedule 33A insert— SCHEDULE33B Transitional Provision in relation to the Windsor Framework Reg 347B Existing marketing authorisations 1. (1) Subject to sub-paragraphs (6), (13) and (14), a UKMA(GB) in force immediately before 1st January 2025 for a medicinal product in respect of which there is or has been in force an EU marketing authorisation, or which belongs to a category of medicinal product referred to in Article 3(1) or (2) of Regulation (EC) No 726/2004, has effect on and after that date as a UKMA(UK)(Category 1). (2) Subject to sub-paragraphs (6), (13) and (14), a UKMA(GB) in force immediately before 1st January 2025 for a generic medicinal product has effect on and after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force for the reference medicinal product. (3) Subject to sub-paragraphs (6), (13) and (14), a UKMA(GB) in force immediately before 1st January 2025 for a hybrid medicinal product has effect on or after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force in relation to the reference medicinal product. (4) Subject to sub-paragraphs (6), (13) and (14), a UKMA(GB) granted in accordance with regulation 53A or Article 10(4) and (6) of the 2001 Directive and in force immediately before 1st January 2025 for a biological medicinal product has effect on and after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force for the reference medicinal product. (5) Subject to sub-paragraphs (6), (13) and (14), any other UKMA(GB) in force immediately before 1st January 2025 has effect on and after that date as a UKMA(UK)(Category 2). (6) If the holder of a UKMA(GB) to which any of sub-paragraphs (1) to (5) applies notifies the licensing authority in writing before 1st January 2025 that it does not wish to be a holder of a UKMA(UK), the licensing authority must revoke the UKMA(GB) with effect from 1st January 2025. (7) A UKMA(UK) which has effect by virtue of any of sub-paragraphs (1) to (5) is treated as if it had been granted by the licensing authority on the same terms as those on which the UKMA(GB) was granted, including any conditions or restrictions subject to which, and retaining any benefits with which, the UKMA(GB) was granted and which remain in force immediately before 1st January 2025. (8) A UKMA(UK) in force immediately before 1st January 2025 for a generic medicinal product has effect on and after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force for the reference medicinal product. (9) A UKMA(UK) in force immediately before 1st January 2025 for a hybrid medicinal product has effect on or after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force in relation to the reference medicinal product. (10) A UKMA(UK) granted in accordance with regulation 53B or Article 10(4) and (6) of the 2001 Directive and in force immediately before 1st January 2025 for a biological medicinal product has effect on or after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force in relation to the reference medicinal product. (11) Any other UKMA(UK) in force immediately before 1st January 2025 has effect on and after that date as a UKMA(UK)(Category 2). (12) A UKMA(UK) which has effect by virtue of sub-paragraph (8) to (10) is treated as if it had been granted by the licensing authority on the same terms as those on which the UKMA(UK) in force before 1st January 2025 was granted, including any conditions or restrictions subject to which, and retaining any benefits with which, the UKMA(UK) was granted and which remain in force immediately before 1st January 2025. (13) Subject to sub-paragraph (14), a UKMA(GB) in force immediately before 1st January 2025 ceases to have effect on 1st January 2025 if— (a) there is a UKMA(NI) in force on 1st January 2025 in relation to the same medicinal product and with the same marketing authorisation holder, and (b) the holder of that UKMA(NI) has not made a request in writing to the licensing authority for the revocation of that UKMA(NI) before 30th September 2024. (14) However, where the holder of the UKMA(NI) referred to in sub-paragraph (13) has made a request in writing to the licensing authority for the revocation of that UKMA(NI) on or after 30th September and before 1st January 2025 and the licensing authority thinks that it is in the interest of patients’ health in the United Kingdom, the UKMA(GB) continues to have effect on 1st January 2025. (15) For the purposes of this paragraph, a medicinal product is a “hybrid medicinal product” if one or more of the circumstances set out in regulation 52B(1)(a) to (c) applied to the application for the UKMA for that product. Existing applications for marketing authorisation 2. (1) An application for a UKMA(GB) made before 1st January 2025 which has not been determined immediately before that date is to be treated on and after that date as an application for a UKMA(UK). (2) Sub-paragraph (3) applies where— (a) an application for a UKMA(UK) was made before 1st January 2025, (b) the application has not been determined immediately before that date, (c) the application was made under regulation 51B as it had effect on the date of the application, and (d) the reference medicinal product was of the description in paragraph (c)(ii) of the definition of that term in regulation 48(2) as it had effect on the date of the application. (3) Where this sub-paragraph applies, regulations 48 and 51B apply in respect of the application as they had effect immediately before 1st January 2025. (4) Sub-paragraph (5) applies where— (a) an application for a UKMA(UK) was made before 1st January 2025, (b) the application has not been determined immediately before that date, (c) the application was made under regulation 52B as it had effect on the date of the application, and (d) the reference medicinal product was of the description in paragraph (c)(ii) of the definition of that term in regulation 48(2) as it had effect on the date of the application. (5) Where this sub-paragraph applies, regulations 48 and 52B apply in respect of the application as they had effect immediately before 1st January 2025. (6) Sub-paragraph (7) applies where— (a) an application for a UKMA(UK) was made before 1st January 2025, (b) the application has not been determined immediately before that date, (c) the application was made under regulation 53B as it had effect on the date of the application, and (d) the reference medicinal product was of the description in paragraph (c)(ii) of the definition of that term in regulation 48(2) as it had effect on the date of the application. (7) Where this sub-paragraph applies, regulations 48 and 53B apply in respect of the application as they had effect immediately before 1st January 2025. Post-authorisation processes 3. (1) Where an application is made before 1st January 2025 for variation of a UKMA(GB) and that application has not been determined immediately before that date, if the authorisation has effect as a UKMA(UK)(Category 2) by virtue of paragraph 1(2), the application must be determined by the licensing authority as if it were an application for a variation of a UKMA(UK)(Category 1). (2) Where a holder of a UKMA(GB) has submitted a draft protocol under regulation 199(2) before 1st January 2025, if the authorisation has effect as a UKMA(Category 2) by virtue of paragraph 1(2), the obligations applied by regulations 198 to 202 apply in relation to the medicinal product concerned on and after 1st January 2025 as if the authorisation were a UKMA(UK)(Category 1). .

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