PART 6MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

Application and effect of manufacturing authorisation41.

A manufacturing authorisation shall apply only in relation to—

(a)

the descriptions of investigational medicinal products;

(b)

the manufacturing, assembling or importation operations; F1...

F2(bb)

in the case of an authorisation relating to the inactivation of viral or non-conventional agents, the manufacturing process; and

(c)

the premises,

specified in the application made pursuant to regulation 38 and in respect of which the authorisation is granted.