The Human Medicines Regulations 2012

Revocation, variation and suspension of certificate of registration U.K.

Revocation, variation and suspension of certificate of registration U.K.

110.—(1) The licensing authority may revoke, vary or suspend a certificate of registration if any of the following conditions are met.

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

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

(b) the risks of the product to the health of patients or of the public outweigh any beneficial effects of the product; or

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

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

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

(a) a term of the certificate; or

(b) a requirement imposed by Chapter 1 of Part 13 (packaging and leaflets).

(5) Condition D is that the licensing authority thinks that a condition to which the certificate is subject by virtue of regulation 105 (conditions of certificate or registration) has not been fulfilled.

(6) Condition E is that the licensing authority thinks that the holder of the certificate has not complied with regulation 115(1) to (3) (requirements to provide information).

(7) Condition F is that the holder of the certificate has ceased to be [F1 established in—

(a) the United Kingdom; or

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

in accordance with the requirements of these Regulations.]

(8) Condition G is that—

(a) the holder applies to vary the certificate; and

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

[F2 (8A) Condition H is that the manufacture and control of the product to which the certificate relates is not in compliance with the particulars provided under regulation 103(8)(c) and (d).]

[F3 (8B) Condition I 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.]

(9) Schedule 11 makes provision about advice and representations in relation to a proposal to revoke, vary or suspend a certificate of registration, other than a proposal to vary a certificate on the application of its holder.

(10) This regulation is subject to regulation 111 (certificates granted under Chapter 4 of Title III of the 2001 Directive).

Textual Amendments

F1 Reg. 110(7)(a)(b) substituted for words in reg. 110(7) (31.12.2020) by S.I. 2019/775, reg. 102(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 80(a))

F2 Reg. 110(8A) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 19

F3 Reg. 110(8B) inserted (31.12.20200 by S.I. 2019/775, reg. 102(2A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 80(b))

Certificates granted under Chapter 4 of Title III of the 2001 Directive U.K.

F4 111.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F4 Reg. 111 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 103; 2020 c. 1, Sch. 5 para. 1(1)

Withdrawal of homoeopathic medicinal product from the market U.K.

112.—(1) This regulation applies if under regulation 110 F5 ... the licensing authority revokes or suspends a certificate of registration.

(2) The licensing authority may give written notice to the person who is, or immediately before its revocation was, the holder of the certificate requiring the holder to comply with the following requirement.

(3) That requirement is to take all reasonably practicable steps to withdraw from the market in the United Kingdom and recover possession of—

(a) the product to which the certificate relates; or

(b) the batches of the product specified in the notice,

within the time and for the period specified in the notice.

(4) The notice must specify the grounds for giving the notice.

Textual Amendments

F5 Words in reg. 112(1) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 104; 2020 c. 1, Sch. 5 para. 1(1)