# The Human Medicines Regulations 2012, Regulation 110: Revocation, variation and suspension of certificate of registration

Extent: E+W+S+N.I.

(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—
(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.
(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).
(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).

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/110 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-110
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.