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Regulation 110 Revocation, variation and suspension of certificate of registration

United Kingdom

(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 F1established 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).

Annotations

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))