The Human Medicines Regulations 2012

Revocation, variation and suspension of UK marketing authorisation

68.—(1) The licensing authority may revoke, vary or suspend a UK marketing authorisation 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.

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

(a) a term of the authorisation; or

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

(5) Condition D is that the licensing authority thinks that a condition to which the authorisation is subject by virtue of regulations 59 (conditions of UK marketing authorisations: general), 60 (conditions of UK marketing authorisations: exceptional circumstances) 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 has ceased to be established in the European Union.

(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 states other than EEA States), 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 other than the United Kingdom; 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 authorisation; and

(b) must notify the suspension to the EMA, the European Commission, and all other member States by the end of the next working day following the day on which the suspension comes into force.

(11) Condition J is that—

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

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

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

(13) This regulation is subject to regulation 70 (authorisations granted under Chapter 4 of Title III of the 2001 Directive).