PART 2 Amendment of the Human Medicines Regulations 2012

Amendment of regulation 37

13.—(1) Regulation 37 (manufacturing and assembly)(1) is amended as follows.

(2) In paragraph (6)—

(a) at the end of sub-paragraph (aa), delete “and”; and

(b) after sub-paragraph (aa) insert—

“(ab) in the case of an MM medicinal product, the MM master file;

(ac) in the case of a POC medicinal product, the POC master file; and”.

(3) In paragraph (8), at the beginning insert “Except in the case of an MM medicinal product or a POC medicinal product,”.

(1)

Regulation 37 was substituted by S.I. 2013/1855 and amended by S.I. 2019/775, 2021/1452 and 2022/352.