Part 7Amendment to Part 6 (Manufacture and Importation of Investigational Medicinal Products)

Insertion of new regulation 37A

regulation 28 + 28.  After regulation 37 (exemption for hospitals and health centres) insert—

Exemption for radiopharmaceuticals used for diagnostic purposes

37A.—(1) The restriction imposed by regulation 36(1) does not apply to the manufacture or assembly of a radiopharmaceutical used for diagnostic purposes where the conditions in paragraph (2) are satisfied.

(2) The conditions referred to in paragraph (1) are that—

(a)the manufacture or assembly is carried out by the holder of a manufacturer’s licence, as defined in regulation 8(1) of the 2012 Regulations, which does not relate to the manufacture of investigational medicinal products; and

(b)the radiopharmaceutical is exclusively for use in a hospital or health centre which is—

(i)a trial location for the clinical trial in which the product is to be used, or

(ii)taking part in the clinical trial.”.