[F1Suspension, revocation etc] of the authorisationE+W+S

5.—(1) The Secretary of State may suspend, vary or revoke a manufacturing authorisation if the holder—

(a)has not complied with these Regulations;

(b)has manufactured a veterinary medicinal product not authorised by the manufacturing authorisation;

(c)has produced a veterinary medicinal product outside the terms of a marketing authorisation; F2...

(d)no longer has suitable premises or equipment.

[F3(e)has failed to carry out the activity specified in the authorisation for a period of five years or more; or

(f)has not paid any fee required under these Regulations]

[F4(2) The Secretary of State may also suspend, vary or revoke the authorisation on being satisfied that the qualified person (manufacture), the person responsible for quality control or the person with responsibility for production is not fulfilling that person’s duties under these Regulations.

(3) In particular, the Secretary of State may—

(a)suspend the manufacture or import of veterinary medicinal products;

(b)suspend, revoke or vary the manufacturing authorisation for one or more pharmaceutical forms;

(c)suspend, revoke or vary the manufacturing authorisation for one or more activities in one or more manufacturing sites.]

Suspension, variation or revocation of the authorisationN.I.

5.—(1) The Secretary of State may suspend, vary or revoke a manufacturing authorisation if the holder—

(a)has not complied with these Regulations;

(b)has manufactured a veterinary medicinal product not authorised by the manufacturing authorisation;

(c)has produced a veterinary medicinal product outside the terms of a marketing authorisation; or

(d)no longer has suitable premises or equipment.

(2) The Secretary of State may also suspend, vary or revoke it on being satisfied that the qualified person (manufacture) is not fulfilling their duties under these Regulations.