The Human Medicines Regulations 2012

Revocation, variation and suspension of certificate of registration

Revocation, variation and suspension of certificate of registration

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 established in the European Union.

(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.

(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).

Certificates granted under Chapter 4 of Title III of the 2001 Directive

111.—(1) Regulation 110 does not apply in relation to a certificate of registration that was granted in accordance with the provisions of Chapter 4 of Title III of the 2001 Directive (mutual recognition procedure and decentralised procedure).

(2) A proposal by the licensing authority to vary, suspend or revoke a certificate of registration within paragraph (1), or an application by the holder of such a certificate to vary or revoke it, is to be determined in accordance with Chapter 4 of Title III of the 2001 Directive.

Withdrawal of homoeopathic medicinal product from the market

112.—(1) This regulation applies if under regulation 110 or regulation 111(2) 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.