SCHEDULE 2The manufacture of veterinary medicinal products
PART 2Authorisation of manufacturers of autogenous vaccines
Types of authorisation16
1
The authorisation must specify the products that may be manufactured.
2
It may either be for the production of a single batch of product or for on-going production of the products specified in the authorisation.
3
If it is for a single batch it must be time-limited.
4
Only the products specified in the authorisation may be manufactured, and in the case of an authorisation for a single batch the product may only be manufactured before the expiry of the authorisation.