Paragraph 15 Authorisation to manufacture autogenous vaccines
(1)
The Secretary of State may authorise a person and premises to manufacture autogenous vaccines for administration in accordance with regulation 15.
(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 she authorises the premises, the Secretary of State must be satisfied that the production process will produce a consistent, safe product.
(4)
Procedure for the suspension or revocation of the authorisation is the same as for the holder of a manufacturing authorisation.
(5)
It is an offence to manufacture an autogenous vaccine other than in accordance with such an authorisation.