SCHEDULE 2The manufacture of veterinary medicinal products

PART 1Manufacturing authorisations

Suspension, variation or revocation of the authorisation5

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.