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Paragraph 16 Types of authorisation

Original text. Later amendments are not shown.

(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.