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2024 No. 832 Medicines The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 Made at 9.54 a.m. on 29th July 2024 Laid before Parliament at 3.15 p.m. on 29th July 2024 Coming into force 1st January 2025 The Secretary of State makes the following Regulations in exercise of the powers conferred by section 8C(1) of and paragraph 21(a)(ii) and (b) of Schedule 7 to the European Union Withdrawal Act 2018.
Propose a change(1) These Regulations may be cited as the Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 and come into force on 1st January 2025. (2) The amendments made by regulations 110, 111 and 140(c) and (d) apply in relation to medicinal products placed on the market for the first time on or after 1st January 2025. (3) These Regulations extend to England and Wales, Scotland and Northern Ireland.
Propose a changeThe Human Medicines Regulations 2012 are amended in accordance with regulations 3 to 146.
Propose a changeIn regulation 2A (definition of advanced therapy medicinal product etc.), in paragraphs (1) and (10), omit “, in their application to products for sale or supply in Great Britain only,”.
Propose a changeIn regulation 3 (scope of these Regulations: special provisions), omit— (a) paragraph (12)(d)(ia); (b) paragraph (15)(aa).
Propose a changeIn regulation 4 (special provisions for pharmacies etc.), omit paragraph (4)(d)(ia).
Propose a changeIn regulation 5 (classification of medicinal products)— (a) in paragraph (1)— (i) at the end of sub-paragraph (a), for “; or” substitute a full stop; (ii) omit sub-paragraph (b); (b) in paragraph (3)— (i) omit sub-paragraph (b); (ii) in sub-paragraph (d) omit “or (b)”; (c) in paragraph (5)— (i) omit sub-paragraph (b); (ii) in sub-paragraph (d) omit “or (b)”.
Propose a changeIn regulation 8 (general interpretation)— (a) in paragraph (1)— (i) omit the definition of “advanced therapy medicinal product”; (ii) in the definition of “Annex I to the 2001 Directive”, after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”; (iii) omit the definition of “Commission Regulation 2016/161”; (iv) in the definition of “conditional marketing authorisation”, for “UKMA (GB)” substitute “UKMA(UK)(Category 1)”; (v) omit the definition of “healthcare institution”; (vi) in the definition of “marketing authorisation”, omit paragraph (b) and the “or” which precedes it; (vii) in the definition of “name”, omit paragraph (b) (but not the “and” which follows it); (viii) in the definition of “pharmacovigilance system”, omit “, EU marketing authorisation”; (ix) in the definition of “pharmacovigilance system master file”, omit “, EU marketing authorisation”; (x) in the definition of “post-authorisation safety study”, omit “, EU marketing authorisation”; (xi) omit the definition of “Regulation (EC) No 1394/2007”; (xii) in the definition of “UK marketing authorisation”, in paragraph (a), after “authorisation” insert “, within the definition of UKMA(UK)(Category 1) or UKMA(UK)(Category 2),”; (xiii) after the definition of “UK marketing authorisation”, insert— “UKMA(UK)(Category 1)” means a marketing authorisation of the description in regulation 49(1ZB); “UKMA(UK)(Category 2)” means a marketing authorisation of the description in regulation 49(1ZC); ; (xiv) in the definition of “under the unfettered access route”, in paragraph (a), for “UKMA(GB)” substitute “UKMA(UK)(Category 2)”; (b) in paragraph (9), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.
Propose a changeIn regulation B17(2)(b) (regulations on good manufacturing practice), omit “or EU marketing authorisation”.
Propose a changeIn regulation C17(1) (guidelines on good manufacturing practice and good distribution practice), for “Great Britain” substitute “the United Kingdom”.
Propose a changeIn regulation 17 (manufacturing of medicinal products)— (a) in paragraph (4), omit sub-paragraph (b) and the “or” which precedes it; (b) in paragraph (7), omit sub-paragraph (b) and the “and” which precedes it; (c) after paragraph (9)(c), insert “and”; (d) omit paragraph (9)(e) and the “and” which precedes it.
Propose a changeIn regulation 18 (wholesale dealing in medicinal products)— (a) in paragraph (6)(b), omit “, EU marketing authorisation”; (b) omit paragraph (7).
Propose a changeIn regulation 19(1)(a)(ii) (exemptions from requirement for wholesale dealer’s licence), omit “, an EU marketing authorisation”.
Propose a changeIn regulation 31 (certification of manufacturer’s licence)— (a) in paragraph (3)(b), omit “, EU marketing authorisation”; (b) in paragraph (5)(a) and (b), omit “, EU marketing authorisation”.
Propose a changeIn regulation 36 (conditions for manufacturer’s licence), omit paragraphs (4) to (7).
Propose a changeIn regulation 37(5)(b) (manufacturing and assembly)— (a) omit “in the case of a product for sale or supply in Great Britain (including a listed NIMAR product for sale or supply from Great Britain to Northern Ireland),”; (b) for the words from “and” to the end substitute “(including in the case of a listed NIMAR product for sale or supply from Great Britain to Northern Ireland)”.
Propose a changeIn regulation 39(8) (further requirements for manufacturer’s licence)— (a) at the end of sub-paragraph (a), for “, and” substitute a full stop; (b) omit sub-paragraph (b).
Propose a changeIn regulation 42 (conditions for wholesale dealer’s licence), omit paragraphs (4), (5) and (6).
Propose a changeIn regulation 43 (obligations of licence holder), omit— (a) “, and EU marketing authorisation” in paragraph (5)(a)(ii); (b) “, EU marketing authorisation” in paragraph (7)(b)(ii)(bb); (c) paragraph (7)(c)(vii); (d) paragraph (10); (e) paragraph (11); (f) “or EU marketing authorisation holder” in paragraph (13).
Propose a changeOmit regulation 43A (requirement for wholesale dealers to decommission the unique identifier).
Propose a changeIn regulation 44 (requirement for wholesale dealers to deal only with specified persons)— (a) in paragraph (6)— (i) at the end of sub-paragraph (d), for “; and” substitute a full stop; (ii) omit sub-paragraph (e); (b) in paragraph (8), for “UKMA(GB)” substitute “UKMA(UK)(Category 2)”.
Propose a changeIn regulation 45A(1A)(a) (brokering in medicinal products), omit paragraph (i).
Propose a changeIn regulation 45E (criteria of broker’s registration), omit paragraph(3)(d)(iii).
Propose a changeIn regulation 45F (provision of information), in paragraph (1), for sub-paragraph (b) substitute— (b) the UK marketing authorisation holder, or, where applicable— (i) the holder of the licence or authorisation granted by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or (ii) the EU marketing authorisation holder, .
Propose a changeIn regulation 46 (requirement for authorisation), omit— (a) paragraph (2)(aa); (b) paragraph (6)(aa).
Propose a change(1) Regulation 48 (application of Part) is amended as follows. (2) In paragraph (2)— (a) omit the definition of “EU reference medicinal product”; (b) in the definition of “excluded reference product”, in paragraph (c), for “53A(1)” substitute “53B(1)”; (c) in the definition of “generic medicinal product”— (i) in paragraph (a), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (ii) in paragraph (b), in the opening words, for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”; (d) in the definition of “reference medicinal product”— (i) omit paragraph (b); (ii) in paragraph (c)— (aa) at the end of sub-paragraph (i), for “; or” substitute a comma; (bb) omit sub-paragraph (ii). (3) In paragraph (7), for “51A(1) and (6)” substitute “51B(1) and (6)”. (4) Omit paragraphs (8) and (9).
Propose a changeIn regulation 49 (application for grant of UK marketing authorisation or parallel import licence)— (a) after paragraph (1), insert— (1ZA) If the licensing authority determines to grant a UKMA(UK) under paragraph (1), it must determine if one or more of the following criteria are met in relation to the medicinal product— (a) it belongs to a category of medicinal product referred to in Article 3(1) of Regulation (EC) No 726/2004; (b) it belongs to a category of medicinal product referred to in Article 3(2) of Regulation (EC) No 726/2004 and— (i) the medicinal product contains an active substance which, on 20th May 2004, was not authorised in the European Union, or (ii) the licensing authority considers that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that granting the marketing authorisation is in the interest of patients’ health in the United Kingdom. (1ZB) If the licensing authority determines that one or more of the criteria in paragraph (1ZA) are met, the marketing authorisation granted is a UKMA(UK)(Category 1). (1ZC) If the licensing authority determines that none of the criteria in paragraph (1ZA) are met, the marketing authorisation granted is a UKMA(UK)(Category 2). (1ZD) The licensing authority may grant a UKMA(NI) under Chapter 4 of Title III of the 2001 Directive where there is an application for a marketing authorisation for a medicinal product, unless there is a UKMA(UK), or an application yet to be determined for a UKMA(UK), for the same medicinal product. ; (b) in paragraph (1A)— (i) in the opening words, for “UKMA(GB)” substitute “UKMA(UK)(Category 2)”; (ii) for sub-paragraph (a) substitute— (a) there is in place, or will be at the time the UKMA(UK)(Category 2) is granted, a UKMA(NI) in respect of the product authorising sale or supply in Northern Ireland, ; (c) in paragraph (3)— (i) in sub-paragraph (a), for “a UKMA(UK) or UKMA(NI) must” substitute “a UK marketing authorisation must, subject to sub-paragraph (b),”; (ii) in sub-paragraph (b)— (aa) for “UKMA(GB)” substitute “UKMA(UK)(Category 2)”, (bb) omit paragraph (ii); (d) after paragraph (3), insert— (3ZA) Where a UKMA(UK)(Category 2) is granted under the unfettered access route, any UKMA(NI) granted in relation to the same medicinal product ceases to have effect. ; (e) in paragraph (9), omit sub-paragraph (b) (but not the “or” which follows it).
Propose a changeIn regulation 50 (accompanying material)— (a) in paragraph (4)— (i) in sub-paragraph (a), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (ii) in sub-paragraph (b), for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”; (b) in paragraph (5A)— (i) omit “in respect of Great Britain”; (ii) for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”; (c) in paragraph (6), omit sub-paragraphs (aa), (ba) and (ca).
Propose a changeIn regulation 50A (requirement for certain applications to include results of paediatric investigation plan)— (a) in paragraph (1), in sub-paragraph (a), omit “UKMA(GB) or”; (b) in paragraph (7), for “UKMA(GB)” substitute “UKMA(UK)(Category 2)”; (c) in paragraph (8), for “a UKMA(UK)” substitute “a UKMA(UK)(Category 2)”.
Propose a changeIn regulation 50E (application for paediatric use marketing authorisation)— (a) in paragraph (1), omit “UKMA(GB) or”; (b) in paragraph (5), for “a UKMA(UK)” substitute “a UKMA(UK)(Category 2)”.
Propose a changeIn regulation 50F(1) (other applications including paediatric indications)— (a) in sub-paragraph (a), for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”; (b) in sub-paragraph (b), at the end insert “or a UKMA(UK)(Category 1)”.
Propose a changeIn regulation 50G (applications relating to orphan medicinal products)— (a) in paragraph (1)— (i) at the end of sub-paragraph (a), for “, and” substitute a full stop; (ii) omit sub-paragraph (b); (b) in paragraph (2), in both places, for “Great Britain” substitute “the United Kingdom”.
Propose a changeIn regulation 50H (applications relating to advanced therapy medicinal products), in paragraphs (1) and (3), for “a UKMA(GB)”, substitute “a UKMA(UK)(Category 1)”.
Propose a changeIn regulation 50I (applications relating to conditional marketing authorisations)— (a) in the heading, omit “for sale or supply in Great Britain only”; (b) in paragraph (1), for “a UKMA(GB)” substitute “a UKMA(UK)(Category 1)”.
Propose a changeIn regulation 51 (application for UKMA(NI) relating to generic medicinal products)— (a) in paragraph (2), omit “as modified by paragraph (3)”; (b) omit paragraphs (3) and (4).
Propose a changeOmit regulation 51A (application for UKMA(GB) relating to generic medicinal products).
Propose a changeFor regulation 51B (application for UKMA(UK) relating to generic medicinal products), substitute— Application for UKMA(UK) relating to generic medicinal products 51B. (1) An applicant for a UKMA(UK) for a generic medicinal product may, by way of derogation from paragraph 10 of Schedule 8, omit from the application the results of pre-clinical tests and of clinical trials if the applicant can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised for not less than eight years under regulation 49(1)(a) (subject to paragraphs (2) and (3)). (2) In the case of an application under this regulation in relation to a salt, ester, ether, isomer, mixture of isomers, complex or derivative of an authorised active substance which differs significantly in properties with regard to safety or efficacy from the active substance in the reference medicinal product, the applicant must supply additional information providing proof of the safety or efficacy of the salt, ester, ether, isomer, mixture of isomers, complex or derivative. (3) The applicant may omit bioavailability studies from an application under this regulation if the applicant can demonstrate that the generic medicinal product meets the relevant criteria as specified in the guidelines referred to in paragraph (4). (4) The licensing authority may publish guidelines specifying the criteria to be met by generic medicinal products for the purpose of omitting bioavailability studies from an application in accordance with paragraph (3). (5) Until replaced by guidelines published under paragraph (4), the guidelines published by the EMA under Article 10(2)(b) of the 2001 Directive continue to apply as they applied immediately before IP completion day (subject to any amendments or variations published under paragraph (4)). (6) If the licensing authority grants a UKMA(UK) in relation to the generic medicinal product in accordance with paragraph (1), it is a term of the authorisation that the product must not be sold or supplied, or offered for sale or supply, in the United Kingdom before the expiry of ten years beginning with the date on which the UK marketing authorisation for the reference medicinal product was granted. (7) If during the first eight of the ten years referred to in paragraph (6) the marketing authorisation holder for the reference medicinal product obtained a UK marketing authorisation for one or more new therapeutic indications, and, during the scientific evaluation prior to their authorisation, the licensing authority considers the new indications bring a significant clinical benefit in comparison with existing therapies, the period of ten years referred to in paragraph (6) is extended to eleven years. (8) Where an application for grant or variation of a UKMA(UK) is made in relation to a new indication for a well-established substance; and significant pre-clinical or clinical studies were carried out in relation to the new indication, the applicant for a UKMA(UK) under paragraph (1) or regulation 52B or 53B, may not refer in its application to those studies for the period of one year beginning with the date on which the licensing authority grants or varies the UKMA(UK) in relation to the new indication. .
Propose a changeIn regulation 52(3) (application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc.), for “Paragraphs (2) to (4) of regulation 51 apply to the application as they apply” substitute “Paragraph (2) of regulation 51 applies to the application as it applies”.
Propose a changeOmit regulation 52A (application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etc.).
Propose a changeFor regulation 52B (application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc.), substitute— Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc. 52B. (1) This Regulation applies where an application is made for a UKMA(UK) by reference to another medicinal product as reference medicinal product which is, or has been, authorised for not less than eight years under regulation 49(1)(a) and one or more of the following circumstances applies in respect of the application— (a) the medicinal product to which the application relates does not fall within the definition of generic medicinal product; (b) bioequivalence with the reference medicinal product cannot be demonstrated through bioavailability studies; or (c) the medicinal product to which the application relates differs from the reference medicinal product in terms of changes in the active substance, therapeutic indications, strength, pharmaceutical form or route of administration. (2) The applicant may, by way of derogation from paragraph 10 of Schedule 8, omit from the application the results of pre-clinical tests and of clinical trials relating to the reference medicinal product, but must provide the results of the appropriate pre-clinical tests or clinical trials relating to the applicable circumstances in paragraph (1). (3) Paragraphs (2), (6) and (7) of regulation 51B apply to the application as they apply to an application made in accordance with paragraph (1) of that regulation. .
Propose a change