The Human Medicines Regulations 2012

PART 2 U.K. Type II variation applications, complex variation applications and new excipient variation applications

Application of this Part U.K.

14.  This Part applies— U.K.

(a) to an application (a “Type II variation application”) to vary a UK marketing authorisation if the variation is a major variation of Type II within the meaning of Article 2(3) of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products M1 [F1 or paragraph 1 of Schedule 10A]; and

(b) to an application to vary a traditional herbal registration that is—

(i) a complex variation application, or

(ii) a new excipient variation application.

Textual Amendments

F1 Words in Sch. 11 para. 14(a) inserted (31.12.2020) by S.I. 2019/775, reg. 63(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(b))

Marginal Citations

M1 OJ No L 334, 12.12.2008, p.7.

15.—(1) In paragraph 14(b)(i) “ complex variation application” means an application by the holder of the registration to vary it so that one or more of the following changes can be made to the product to which it relates— U.K.

(a) a change in the product's active ingredients by the addition of an active ingredient from a new source;

(b) a change in the product's excipients by the addition of a TSE risk excipient from a new source; or

(c) a change by the addition of a vitamin or mineral from a new source, where no European Pharmacopoeia certificate of suitability for the vitamin or mineral is submitted with the application.

(2) For the purpose of sub-paragraph (1), an ingredient, vitamin or mineral is “from a new source” if its manufacturer as named in the application has not been named as its manufacturer in a [F2 UK] marketing authorisation or traditional herbal registration granted for a medicinal product including the ingredient, vitamin or mineral.

(3) For the purpose of sub-paragraph (1), an excipient is a “TSE risk excipient from a new source” if—

(a) it has been manufactured from raw materials of ruminant origin or such raw materials have been used in its manufacture; and

(b) its manufacturer as named in the application has not been named as its manufacturer in a [F3 UK] marketing authorisation or traditional herbal registration granted for a medicinal product that includes the excipient.

Textual Amendments

F2 Word in Sch. 11 para. 15(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(5); 2020 c. 1, Sch. 5 para. 1(1)

F3 Word in Sch. 11 para. 15(3)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(5); 2020 c. 1, Sch. 5 para. 1(1)

16.—(1) In paragraph 14(b)(ii) “ new excipient variation application” means an application (other than a complex variation application) by the holder of the registration to vary it so that the formulation of the medicinal product to which it relates can be changed by the addition of a new excipient. U.K.

(2) For the purpose of sub-paragraph (1) “new excipient” means, subject to paragraphs (3) and (4), an ingredient of a medicinal product that is not an active ingredient and that has not been included in a medicinal product—

(a) intended to be administered by the same route as the product to which the application relates; and

(b) for which a [F4 UK] marketing authorisation (other than a product licence of right) or traditional herbal registration has been granted.

(3) In the application of sub-paragraph (1) to a medicinal product intended to be administered orally, the reference to a new excipient does not include any ingredient specified in an enactment as an approved ingredient or additive in food or in a food product.

(4) In the application of sub-paragraph (1) to a medicinal product intended for external use only, the reference to a new excipient does not include any ingredient specified in an enactment as an approved ingredient or additive in a cosmetic product.

(5) In this paragraph “enactment” includes an enactment comprised in subordinate legislation F5 ....

Textual Amendments

F4 Word in Sch. 11 para. 16(2)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(6)(a); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Sch. 11 para. 16(5) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(6)(b); 2020 c. 1, Sch. 5 para. 1(1)

[F6 17.   In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.] U.K.

Textual Amendments

F6 Sch. 11 para. 17 substituted (31.12.2020) by S.I. 2019/775, reg. 63(7) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(c))

Opportunity to make representations U.K.

18.—(1) This paragraph applies if the licensing authority notifies the applicant for a variation to which this Part applies that it has decided, on grounds relating to safety, quality or efficacy— U.K.

(a) to refuse to grant the application, or

(b) to grant it otherwise than in accordance with the application.

(2) The applicant may by notice in writing to the licensing authority request the opportunity to make written or oral representations to the appropriate committee.

(3) The applicant must make the request within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(4) The licensing authority must inform the appropriate committee of the applicant or holder's request.

Written representations U.K.

19.—(1) If the applicant requests the opportunity to make written representations, the applicant must provide the appropriate committee with those representations and any documents on which the applicant wishes to rely in support of them— U.K.

(a) before the end of the period of six months beginning with the date of the request; or

(b) before the end of such shorter period as the licensing authority may specify in the notification under paragraph 18.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 18.

(3) The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) The appropriate committee must—

(a) take the representations made under this paragraph into account; and

(b) report its findings and advice to the licensing authority together with the reasons for that advice.

Oral representations U.K.

20.—(1) If the applicant requests the opportunity to make oral representations, the applicant must provide the appropriate committee with a written summary of those representations and any documents on which the applicant wishes to rely in support of them— U.K.

(a) before the end of the period of six months beginning with the date of the request; or

(b) before the end of such shorter period as the licensing authority may specify in the notification under paragraph 18.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 18.

(3) The applicant may submit additional written representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant to make oral representations at a hearing before the committee.

(5) The appropriate committee must—

(a) take the representations made under this paragraph into account; and

(b) report its findings and advice to the licensing authority together with the reasons for that advice.

Other decisions of the appropriate committee U.K.

21.—(1) This paragraph applies if the applicant— U.K.

(a) requests the opportunity to make written representations, but fails to make those written representations within the period for doing so; or

(b) requests the opportunity to make oral representations, but—

(i) fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii) fails to make oral representations at a hearing before the appropriate committee.

(2) The appropriate committee must notify the licensing authority of that fact.

Decision of licensing authority following report U.K.

22.—(1) After receiving the appropriate committee's report under paragraph 19 or 20 or notification under paragraph 21 the licensing authority must confirm or alter its decision. U.K.

(2) If the appropriate committee gives a report under paragraph 19 or 20, the licensing authority must take that into account in making its decision.

(3) The licensing authority must notify the applicant or holder of—

(a) its decision; and

(b) any advice given to it by the appropriate committee and the reasons for that advice.

Right to review after paragraph 22 notification U.K.

23.—(1) This paragraph applies if the licensing authority notifies the applicant of its decision under paragraph 22— U.K.

(a) to refuse the application; or

(b) to grant it otherwise than in accordance with the application.

(2) The applicant may notify the licensing authority in writing that the person wishes the licensing authority to submit the decision to review upon oral representations.

(3) The applicant must give the notification within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(4) The review must be conducted in accordance with Schedule 5.

(5) This paragraph does not apply if the person has not made any representations in accordance with paragraph 19 or 20.