PART 2 Amendment of the Human Medicines Regulations 2012

Amendment of regulation 188
27. (1) Regulation 188 (recording obligations on holders) is amended as follows.
Regulation 188(1) was amended by S.I. 2019/775 and 2021/1452. Paragraph (1A) was inserted by S.I. 2019/775. There are other amendments but none is relevant.
(2) In paragraph (1)—
(a) at the beginning insert “Subject to paragraphs (1B) and (1C),”; and
(b) after sub-paragraph (c) insert—

“(ca) in the case of an MM medicinal product or a POC medicinal product, ensure that all appropriate measures are taken to identify the product by batch number, or other product identifier if no batch number is available;”.

(3) In paragraph (1A)—
(a) at the beginning insert “Subject to paragraphs (1B) and (1C),”; and
(b) after sub-paragraph (b) insert—

“(ba) in the case of an MM medicinal product or a POC medicinal product, ensure that all appropriate measures are taken to identify the product by batch number, or other product identifier if no batch number is available;”.

(4) After paragraph (1A) insert—

“(1B) In the case of an MM medicinal product, the periods of 15 and 90 days referred to in in paragraphs (1) and (1A) begin on the day following the day on which the holder of the marketing authorisation gained knowledge of the reaction.
(1C) In the case of a POC medicinal product, the periods of 15 and 90 days referred to in paragraphs (1) and (1A) begin on the day following the day on which the holder of the marketing authorisation gained knowledge of the reaction.”.