CHAPTER 3MANUFACTURING OR IMPORT AUTHORISATION

Article 12

1

In order to ensure that the requirements laid down in Article 10 are complied with, authorisation may be made conditional on the carrying out of certain obligations imposed either when authorisation is granted or at a later date.

2

An authorisation shall apply only to the premises specified in the application and to the types of medicinal products and pharmaceutical forms specified in that application pursuant to point (a) of Article 10(1).