The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
27 Amendment of regulation 188
(1) Regulation 188 (recording obligations on holders) is amended as follows. (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. .
27 Amendment of regulation 188
(1) Regulation 188 (recording obligations on holders) is amended as follows. (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. .
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