The Medicines for Human Use (Clinical Trials) Regulations 2004

3.  A statement of the manufacturing, assembling or importation operations to which the authorisation is to relate, including a statement whether they include one or more of the following—U.K.

(a)the manufacture of investigational medicinal products;

(b)the assembly of investigational medicinal products; or

(c)the importation of investigational medicinal products.