Paragraph 4 The authorisationE1

England, Wales and Scotland

(1)

The manufacturing authorisation must specify—

(a)

the types of veterinary medicinal products and pharmaceutical forms that may be manufactured F1, controlled or imported;

F2(b)

the name and address of the site where the products are to be manufactured or controlled, or to which they are to be imported;

(c)

the name and address of the person holding the authorisation;

(d)

the address of the premises to which it relates;

(e)

the names of all qualified persons nominated to act under this Schedule.

(2)

It may specify that different activities must be carried out in different premises or parts of premises, and may require the holder of the manufacturing authorisation to restrict access to premises or parts of premises to persons carrying out activities there.

(3)

The holder of a manufacturing authorisation must notify the Secretary of State, and if necessary apply for a variation of the authorisation, before making a material alteration to the premises or facilities used under the authorisation, or to the operations for which they are used.

Annotations

Textual amendments

F1: Word in Sch. 2 para. 4(1)(a) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 83(a)
F2: Sch. 2 para. 4(1)(b) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 83(b)

Extent

E1: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only