The Human Medicines Regulations 2012

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Revocation, variation and suspension of UK marketing authorisation [F1or parallel import licence] U.K.

This section has no associated Explanatory Memorandum

68.—(1) The licensing authority may revoke, vary or suspend a UK marketing authorisation [F2or parallel import licence] if any of the following conditions is met.

(2) Condition A is that the licensing authority thinks that—

(a)the product to which the authorisation relates is harmful;

(b)the positive therapeutic effects of the product do not outweigh the risks of the product to the health of patients or of the public;

(c)the product lacks therapeutic efficacy, in that therapeutic results cannot be obtained from the product; or

(d)the product's qualitative or quantitative composition is not as described in the application for the authorisation or the material supplied with it.

(3) Condition B is that the licensing authority thinks that the application or the material supplied with it is incorrect.

[F3(4) Condition C is that the licensing authority thinks that there has been a breach of—

(a)a term of the authorisation or licence;

(b)in the case of a UK marketing authorisation, a requirement imposed by Part 13 (packaging and leaflets); or

(c)in the case of a parallel import licence, a requirement in relation to packaging and leaflets imposed by the licensing authority.]

[F4(5) Condition D is that the licensing authority thinks that a condition to which—

(a)the UK marketing authorisation or parallel import licence is subject by virtue of regulation 59 (conditions of UK marketing authorisations or parallel import licence: general); or

(b)the UK marketing authorisation is subject by virtue of regulations 60 (conditions of UK marketing authorisations: exceptional circumstances) [F5, regulation 60A (conditions as to testing of samples by the appropriate authority)] or 61 (conditions of UK marketing authorisations: new obligations post-authorisation),

has not been fulfilled.]

(6) Condition E is that the licensing authority thinks that the holder of the authorisation has not complied with regulation 75(1) to (3) (requirements to provide information).

(7) Condition F is that the holder of the authorisation [F6or licence] has ceased to be [F7established in—

(a)the United Kingdom; or

(b)in relation to a UKMA(NI), either the United Kingdom or the European Union,

in accordance with the requirements of these Regulations.]

(8) Condition G is that—

(a)the product to which the authorisation relates is manufactured in the United Kingdom; and

(b)the licensing authority thinks that the holder of the manufacturer's licence for the product has failed to comply in relation to the product with regulations 37 (manufacturing and assembly), 38 (imports from [F8countries other than approved countries for import]), 39 (further requirements for manufacturer's licence), 40 (obligation to provide information relating to control methods) or 41 (requirements as to qualified persons).

(9) Condition H is that—

(a)the product to which the authorisation relates is manufactured in a member State F9...; and

(b)the licensing authority thinks that the licensee under the manufacturer's licence for the product has failed to comply in relation to the product with provision giving effect to Article 41 of the 2001 Directive (requirements relating to manufacturing authorisations) in that member State.

(10) Condition I is that the licensing authority thinks that urgent action to protect public health is necessary, in which case it—

(a)may suspend the [F10authorisation or licence.]

F11(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(11) Condition J is that—

(a)the holder applies to vary the authorisation [F12or licence]; and

(b)the licensing authority thinks that the application should be granted.

[F13(11A) Condition K is that the manufacture of the product to which the authorisation relates is not carried out in compliance with the particulars provided under paragraphs 5 and 9 of Schedule 8.]

[F14(11B) Condition L is that the licensing authority thinks that the term of the authorisation which specifies the way in which the product is to be made available, as described in regulation 62(1), is incorrect.

(11C) Condition M is that, in respect of a parallel import licence, the UK marketing authorisation in respect of the medicinal product that was specified in the application for that licence under paragraph 4 of Schedule 8A, has been varied, suspended or revoked by the licensing authority under this regulation.

(11D) Condition N is that, in respect of a parallel import licence, the licensing authority is no longer satisfied that the product is essentially similar to a product that has been granted a UK marketing authorisation.

(11E) The licensing authority may not exercise its powers under paragraph (1) by virtue of the condition in paragraph (11D)—

(a)before the end of the period of one year beginning with IP completion day; and

(b)in any event, in a way that prevents the import of any medicinal product in respect of which a qualified person undertook the certification referred to in Article 51(3) of the 2001 Directive before IP completion day.

(11F) Condition O is that the licensing authority thinks that a variation of a UK marketing authorisation is necessary as a result of the submission of the results of a study by the holder of that authorisation under regulation 78A(14).

(11G) Condition P is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.]

(12) Schedule 11 makes provision about advice and representations in relation to a proposal to revoke, vary or suspend a UK marketing authorisation [F15or parallel import licence], other than a proposal to vary an authorisation [F16or licence] on the application of its holder.

F17(13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1Words in reg. 68 heading inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 68 heading inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(h)

F2Words in reg. 68(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 68(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(i)

F3Reg. 68(4) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 11(2) and reg. 68(4) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 11(2)

F4Reg. 68(5) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 11(3) and reg. 68(5) substituted (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 11(3)

F5Words in reg. 68(5) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(2); 2020 c. 1, Sch. 5 para. 1(1)

F6Words in reg. 68(7) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F7Reg. 68(7)(a)(b) and words substituted for words (31.12.2020) by S.I. 2019/775, reg. 77(3)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 57(a))

F8Words in reg. 68(8)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(4); 2020 c. 1, Sch. 5 para. 1(1)

F9Words in reg. 68(9)(a) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 77(5) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 57(b))

F10Words in reg. 68(10)(a) substituted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(6)(a); 2020 c. 1, Sch. 5 para. 1(1)