The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
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Change 1
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). .
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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