SCHEDULE 2The manufacture of veterinary medicinal products
PART 2Authorisation of manufacturers of autogenous vaccines
Authorisation to manufacture autogenous vaccines
14.
(1)
The Secretary of State may authorise a person to manufacture autogenous vaccines and may authorise premises for the purpose of such manufacture by that person.
(2)
In order to be authorised the premises must be under the supervision of—
(a)
a veterinary surgeon; or
(b)
a person who the Secretary of State is satisfied has sufficient qualifications and experience to manufacture the product safely.
(3)
Before authorising the premises, the Secretary of State must be satisfied that the production process will produce a consistent, safe product.
(4)
No person may manufacture an autogenous vaccine other than in accordance with an authorisation under sub-paragraph (1).