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In force since 2025-01-01, as the publisher states.
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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 53(3) (application for UKMA(NI) relating to similar biological medicinal products), 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 53A (application for UKMA(GB) relating to similar biological medicinal products).
Propose a changeFor regulation 53B (application for UKMA(UK) relating to similar biological medicinal products) substitute— Application for UKMA(UK) relating to similar biological medicinal products 53B. (1) This regulation applies in relation to an application for a UKMA(UK) for a biological medicinal product where the applicant is not able to show that it meets a condition for it being ageneric version of a similar medicinal product because ofdifferences relating to raw materials or differences inmanufacturing processes of the biological medicinal productand the reference medicinal product which isthe subject of a UKMA(UK). (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 a reference medicinal product which is or has been authorised for not less than eight years, but must provide the results of appropriate pre-clinical tests or clinical trials relating to the differences referred to in paragraph (1). (3) The type and quantity of supplementary data to be provided by the applicant under paragraph (2) must comply with the relevant criteria in Annex 1 to the 2001 Directive and in the related detailed guidelines published by the licensing authority under paragraph (4), or (as the case may be) as mentioned in paragraph (5). (4) The licensing authority may publish guidelines concerning the type and quantity of supplementary data to be provided by an applicant under paragraph (2). (5) Unless replaced by guidelines published under paragraph (4), the guidelines published by the EMA under Article 10(4) of the 2001 Directive continue to apply as they applied immediately before IP completion day (subject to any amendments or variations published under that paragraph). (6) If the licensing authority grants a UKMA(UK), in relation to the similar biological medicinal product in accordance with paragraph (2), 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 requested and obtained a UKMA(UK) for one or more new therapeutic indications, and, during the scientific evaluation prior to their authorisation, the licensing authority considers that new indications bring a significant clinical benefit in comparison with existing therapies, the period of ten years is extended to eleven years. (8) Where an application is made for the grant or variation of a UKMA(UK) 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) 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 a UKMA(UK) in relation to the new indication. .
Propose a changeIn regulation 55 (applications relating to new combinations of active substances)— (a) in paragraph (1)(b)— (i) omit paragraph (ii) (but not the “or” which follows it); (ii) in paragraph (iii), for sub-paragraph (bb) substitute— (bb) a UKMA(NI). ; (b) omit paragraph (3).
Propose a changeIn regulation 58(8) (consideration of application), for “UKMA(GB)”, substitute “UKMA(UK)(Category 2)”.
Propose a changeIn regulation 58A (paediatric rewards)— (a) in paragraph (3)— (i) at the end of sub-paragraph (a), for “; or” substitute a comma; (ii) omit sub-paragraph (b); (b) in paragraph (4)(b), for “regulation 51A(6), under regulation 51A(12)” substitute “regulation 51B(6), under regulation 51B(7)”; (c) in paragraph (8), for “regulation 51A(1) and (6)” substitute “regulation 51B(1) and (6)”.
Propose a changeIn regulation 58F(1)(b) (consideration of applications relating to conditional marketing authorisations), for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”.
Propose a changeIn regulation 59 (conditions of UK marketing authorisation or parallel import licence: general)— (a) in paragraph (3), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (b) in paragraph (3A), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”; (c) in paragraph (3B)— (i) omit “in respect of Great Britain”; (ii) after “may be required”, insert “in relation to a UKMA(GB) or UKMA(UK)(Category 1)”; (d) in paragraph (5), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.
Propose a changeIn regulation 60(9) (conditions of UK marketing authorisation or parallel import licence: exceptional circumstances), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.
Propose a changeIn regulation 60A (condition as to the submitting of samples and other information to the appropriate authority)— (a) in paragraph (1), for the definition of “the batch testing exemption”, substitute— “the batch testing exemption” means that— in the case of a medicinal product for sale or supply in Northern Ireland only and authorised under a UKMA(NI) or a UKMA(UK)(Category 2), a certificate— has been issued by a laboratory in an EEA State, and in the case of a product of a kind listed in Article 114(1) of the 2001 Directive, was issued in the same EEA State as that in which the batch was manufactured, and the appropriate authority is satisfied that the certificate provides confirmation of conformity with the approved specifications in the UKMA(NI) or UKMA(UK)(Category 2), as applicable, or in the absence of such a certificate, or in the case of a medicinal product authorised for sale or supply under a UKMA(GB) or a UKMA(UK)(Category 1)— a certificate has been issued by a laboratory in a country other than the United Kingdom, an agreement has been made between that country and the United Kingdom (whether or not the agreement is solely with that country, a group of countries or an organisation of which that country is a part), and that agreement is to the effect that the appropriate authority will recognise that certificate in respect of the batch of the medicinal product, in place of the appropriate authority’s own examination of a sample from the batch, the appropriate documentation or both. ; (b) in paragraph (5), omit “and regulation 60B(5)”; (c) in paragraph (9)(a) and (b), omit “or regulation 60B”; (d) in paragraph (10), for “Where” substitute “Subject to paragraph (10A), where”; (e) after paragraph (10), insert— (10A) Where a holder of a UK marketing authorisation intends to rely on paragraph (a) of the batch testing exemption in relation to a batch of a medicinal product, that holder must not sell or supply, or offer to sell or supply, in Northern Ireland, a medicinal product that forms part of that batch until the appropriate authority has confirmed that it is satisfied as set out in that paragraph. .
Propose a changeOmit regulation 60B (submitting of samples and other information: EU marketing authorisations).
Propose a changeIn regulation 61 (conditions of UK marketing authorisation: new obligations post-authorisation)— (a) in paragraph (4)(b), after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”; (b) in paragraph (6), for “or UKMA(UK)” substitute “or UKMA(UK)(Category 2)”; (c) in paragraph (6A), after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”; (d) for paragraph (7), substitute— (7) The obligation under paragraph (5) must be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive while taking account of the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies. ; (e) omit paragraph (7A); (f) in paragraph (13), for “or UKMA(UK)” substitute “or UKMA(UK)(Category 2)”.
Propose a changeIn regulation 64(4)(d) (duties of licensing authority in connection with determination)— (a) in paragraph (i), for “or UKMA(UK)” substitute “or UKMA(UK)(Category 2)”; (b) in paragraph (ii), after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”.
Propose a changeIn regulation 65C (variation of a UKMA(GB)), in the heading, and in paragraphs (1) and (3), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”.
Propose a changeIn regulation 66(2) (application for renewal of authorisation)— (a) for sub-paragraph (a) substitute— (a) a UK marketing authorisation, must, subject to sub-paragraph (b), be established in the UK or an EEA State; and ; (b) in sub-paragraph (b)— (i) for “UKMA(GB)” substitute “UKMA(UK)(Category 2)”; (ii) omit paragraph (ii); (c) omit sub-paragraph (c).
Propose a changeIn regulation 67 (failure to place on the market etc.), in paragraphs (1) and (2) omit “or, in the case of a UKMA(GB) granted after an application under the unfettered access route, in Great Britain”.
Propose a changeIn regulation 68 (revocation, variation and suspension of UK marketing authorisation or parallel import licence)— (a) in paragraph (7)— (i) for sub-paragraph (a) substitute— (a) Northern Ireland, in the case of a UKMA(UK)(Category 2) granted under the unfettered access route, and ; (ii) for sub-paragraph (b) substitute— (b) the United Kingdom or an EEA State, in any other case, ; (b) after paragraph (11G) insert— (11H) Condition Q is that, in relation to a UKMA(UK)(Category 2), the licensing authority thinks that a variation is necessary in the interest of patients’ health in the United Kingdom so that the authorisation is treated as a UKMA(UK)(Category 1). (11I) Condition R is that, in relation to a UKMA(UK)(Category 2), the licensing authority thinks that a variation is necessary in the interest of patients’ health in the United Kingdom so that the authorisation is treated as a UKMA(GB) and separate UKMA(NI). (A12) Where Condition R is met, and the licence holder requests the cancellation of, or fails to renew, either the UKMA(GB) or UKMA(NI) that result from a variation being made under paragraph 11I, the licensing authority may revoke the corresponding UKMA(NI) or UKMA(GB) that results from that variation. .
Propose a changeIn regulation 71(1), for sub-paragraph (b) (withdrawal of medicinal product from the market) substitute— (b) under regulation 69 the licensing authority suspends the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a UK marketing authorisation relates. .
Propose a changeIn regulation 72(1) (sale etc. of suspended medicinal product), for sub-paragraphs (a) and (b), and the em dash which precedes them, substitute “regulation 69”.
Propose a changeIn regulation 73(5C) (obligation to notify placing on the market etc.), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.
Propose a changeIn regulation 76(2) (obligation in relation to product information)— (a) in sub-paragraph (a), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”; (b) in sub-paragraph (b), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”.
Propose a changeIn regulation 78B (post authorisation requirements in relation to UKMA(GB) for advanced therapy medicinal products)— (a) in the heading, for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”; (b) in paragraph (1)— (i) in the opening words, for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”; (ii) in sub-paragraph (c), for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”; (iii) in sub-paragraph (d), for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”; (c) in both places in paragraph (2), for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”.
Propose a changeIn regulation 79(1) and (2) (failure to provide information on marketing authorisations to EMA) for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.
Propose a changeIn regulation 80 (urgent safety restrictions)— (a) in paragraph (a)(ii), for “, UKMA(UK) or EU marketing authorisation” substitute “or UKMA(UK)(Category 2)”; (b) in paragraph (b)(i), after “UKMA(GB)” insert “or UKMA(UK)(Category 2)”; (c) in paragraph (b)(ii), for “or UKMA(UK)” substitute “or UKMA(UK)(Category 2)”; (d) in paragraph (d), after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”.
Propose a changeIn regulation A81 (application of regulations 81 to 94), and in the heading to that regulation, for “81” substitute “89”.
Propose a changeOmit regulations 81 to 88 (offences relating to EU marketing authorisations).
Propose a changeOmit regulation 94A (offences relating to Commission Regulation 2016/161).
Propose a changeIn regulation 95 (offences in connection with application)— (a) after paragraph (a), insert “or”; (b) omit paragraphs (c) and (d).
Propose a changeIn regulation 101(3) (defences), for “88” substitute “89”.
Propose a changeIn regulation 159(1) (provisional determination), omit “or an EU marketing authorisation”.
Propose a changeIn regulation 164 (effect of final determination), in paragraph (2)(a) and (b), omit “or an EU marketing authorisation”.
Propose a changeIn regulation 169(9)(a) (mixing of general sale medicinal products), omit “or EU marketing authorisation”.
Propose a changeIn regulation 171(2)(c) (exempt advanced therapy medicinal products), for the words from “under” to the end, substitute “under regulation 49(1)”.
Propose a changeIn regulation 173(c) (exemption for certain radiopharmaceuticals), omit “or EU marketing authorisation”.
Propose a changeIn regulation 177 (application of Part and interpretation)— (a) in paragraph (1A), for “UKMA(GB) ora THR(GB)” substitute “UKMA(GB), UKMA(UK)(Category 1) or a THR(GB)”; (b) omit paragraph (4); (c) in paragraph (5), in the definition of “signal”, after “UKMA(GB)” insert “, UKMA(UK)(Category 1)”.
Propose a changeIn regulation 180 (obligation on licensing authority to audit pharmacovigilance system)— (a) in paragraph (1), for “in Great Britain” substitute “pursuant to a UKMA(GB) or a UKMA(UK)(Category 1)”; (b) in paragraph (1A), after “Northern Ireland” insert “pursuant to a UKMA(NI) or a UKMA(UK)(Category 2)”.
Propose a changeIn regulation 181(1) (delegation of obligations under this Part), after “Northern Ireland” insert “pursuant to a UKMA(NI) or a UKMA(UK)(Category 2)”.
Propose a changeIn regulation 184(3) (obligation on holder to audit pharmacovigilance system), after “UKMA(GB)” insert “, UKMA(UK)(Category 1)”.
Propose a changeIn regulation 186(1) (reporting obligations on the licensing authority)— (a) in sub-paragraph (d), for paragraph (ii) substitute— (ii) a UKMA(UK)(Category 2), ; (b) in sub-paragraph (e), for paragraph (ii) substitute— (ii) a UKMA(UK)(Category 2), .
Propose a changeIn regulation 188 (reporting obligations on holders)— (a) in paragraph (1A)— (i) in the opening words, for “a UKMA(UK)” substitute “a UKMA(UK)(Category 2)”; (ii) in sub-paragraphs (a) and (b), after “on the day” insert “following the day”; (b) in paragraph (2), in the opening words, for “a UKMA(UK)” substitute “a UKMA(UK)(Category 2)”; (c) in paragraph (4A), in the opening words, for “a UKMA(UK)” substitute “a UKMA(UK)(Category 2)”.
Propose a change