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

Amendment to regulation 36

regulation 27 + 27.  In regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products), in paragraph (1), for “regulation 37” substitute “regulations 37 and 37A”.

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.”.

Amendment to regulation 40

regulation 29 + 29.  In regulation 40 (grant or refusal of manufacturing authorisation), in paragraph (1)(a)(ii)(1), after “Commission Directive 2003/94/EC” insert “in respect of Great Britain, or of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland”.

Amendment to regulation 43

regulation 30 + 30.—(1) Regulation 43 (qualified persons) is amended as follows.

(2) In paragraph (2A)(b)(2), for “Article 13 of the Directive” substitute “Article 62 of the EU Regulation”.

(3) In paragraph (2C)(b), after “Commission Directive 2003/94/EC” insert “in respect of Great Britain or Commission Delegated Regulation 2017/1569 in respect of Northern Ireland”.

(4) In paragraph (5)(3), for “the said Article 49 or 50” substitute “Schedule 7 to the 2012 Regulations”.

(5) In paragraph (6)(a)(i), for “the said Articles 49 or 50 of Directive 2001/83/EC” substitute “Schedule 7 to the 2012 Regulations”.