PART 2 Amendment of the Human Medicines Regulations 2012

Insertion of new regulations 29A and 29B (variation of MM and POC master files)

12.  After regulation 29 (variation of licence on the application of the holder) insert—

“Variation of MM master file

29A.   Except where regulation 27A(1) applies, the holder of a manufacturer’s licence (MM) may amend the information in the MM master file provided in accordance with paragraph 1A(2)(a), (c) and (h) to (k) of Schedule 3 without applying to the licensing authority for a variation under regulation 29.

Variation of POC master file

29B.   Except where regulation 27A(2) applies, the holder of a manufacturer’s licence (POC) may amend the information in the POC master file provided in accordance with paragraph 1B(2)(a), (b) and (g) to (j) of Schedule 3 without applying to the licensing authority for a variation under regulation 29.”.