Paragraph 16 Types of authorisationI1

The authorisation shall specify the products that may be manufactured.

It shall either be for the production of a single batch of product or for on-going production of the products specified in the authorisation.

If it is for a single batch the authorisation shall be time-limited.

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.