The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
20 Amendment of regulation 167G
(1) Regulation 167G (EAMS medicinal products: pharmacovigilance) is amended as follows. (2) In paragraph (1)— (a) at the beginning insert “Subject to paragraphs (1A) and (1B),”; and (b) in sub-paragraph (c), at the end insert “and, in the case of an MM medicinal product or a POC medicinal product, include the product’s batch number or other product identifier if no batch number is available”. (3) After paragraph (1) insert— (1A) In the case of an MM medicinal product, the periods of 15 and 90 days referred to in paragraph (1)(c) begin on the day following the day on which the holder of the scientific opinion gained knowledge of the reaction. (1B) In the case of a POC medicinal product, the periods of 15 and 90 days referred to in paragraph (1)(c) begin on the day following the day on which the holder of the scientific opinion gained knowledge of the reaction. .
20 Amendment of regulation 167G
(1) Regulation 167G (EAMS medicinal products: pharmacovigilance) is amended as follows. (2) In paragraph (1)— (a) at the beginning insert “Subject to paragraphs (1A) and (1B),”; and (b) in sub-paragraph (c), at the end insert “and, in the case of an MM medicinal product or a POC medicinal product, include the product’s batch number or other product identifier if no batch number is available”. (3) After paragraph (1) insert— (1A) In the case of an MM medicinal product, the periods of 15 and 90 days referred to in paragraph (1)(c) begin on the day following the day on which the holder of the scientific opinion gained knowledge of the reaction. (1B) In the case of a POC medicinal product, the periods of 15 and 90 days referred to in paragraph (1)(c) begin on the day following the day on which the holder of the scientific opinion gained knowledge of the reaction. .
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