The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
5 Amendment of regulation 17
(1) Regulation 17 (manufacturing of medicinal products) is amended as follows. (2) In paragraph (1), after “a licence” insert “of the appropriate type”. (3) After paragraph (1) insert— (1A) For the purposes of paragraph (1), the appropriate type of manufacturer’s licence is a licence that relates to whichever, or whichever combination, of the following that is appropriate— (a) manufacture and assembly of medicinal products, except for advanced therapy medicinal products, MM medicinal products, POC medicinal products or special medicinal products; (b) import of medicinal products, except for special medicinal products, MM medicinal products or POC medicinal products; (c) manufacture and assembly of advanced therapy medicinal products; (d) manufacture and assembly of MM medicinal products; (e) manufacture and assembly of POC medicinal products; (f) manufacture and assembly of special medicinal products; (g) import of special medicinal products. . (4) After paragraph (9) insert— (10) Regulation 17A sets out additional requirements in relation to the manufacture or assembly of MM medicinal products. (11) Regulation 17B sets out additional requirements in relation to the manufacture or assembly of POC medicinal products. .
5 Amendment of regulation 17
(1) Regulation 17 (manufacturing of medicinal products) is amended as follows. (2) In paragraph (1), after “a licence” insert “of the appropriate type”. (3) After paragraph (1) insert— (1A) For the purposes of paragraph (1), the appropriate type of manufacturer’s licence is a licence that relates to whichever, or whichever combination, of the following that is appropriate— (a) manufacture and assembly of medicinal products, except for advanced therapy medicinal products, MM medicinal products, POC medicinal products or special medicinal products; (b) import of medicinal products, except for special medicinal products, MM medicinal products or POC medicinal products; (c) manufacture and assembly of advanced therapy medicinal products; (d) manufacture and assembly of MM medicinal products; (e) manufacture and assembly of POC medicinal products; (f) manufacture and assembly of special medicinal products; (g) import of special medicinal products. . (4) After paragraph (9) insert— (10) Regulation 17A sets out additional requirements in relation to the manufacture or assembly of MM medicinal products. (11) Regulation 17B sets out additional requirements in relation to the manufacture or assembly of POC medicinal products. .
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