The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
42 Insertion of new regulations 36A and 36B (manufacture of MM and POC investigational medicinal products)
After regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products) insert— Manufacture of MM investigational medicinal products 36A. (1) No person shall manufacture or assemble an MM investigational medicinal product unless— (a) the activity and product type is specified in a manufacturing authorisation (MM); and (b) there is an MM (IMP) master file relating to the product and the product is manufactured and assembled in accordance with that master file. (2) Paragraph (1) does not apply to the manufacture or assembly of an MM investigational medicinal product to the extent that the manufacture or assembly is in accordance with the terms and conditions of a UK marketing authorisation or a marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC relating to that product. Manufacture of POC investigational medicinal products 36B. (1) No person shall manufacture or assemble a POC investigational medicinal product unless— (a) the activity and product type is specified in a manufacturing authorisation (POC); and (b) there is a POC (IMP) master file relating to the product and the product is manufactured and assembled in accordance with that master file. (2) Paragraph (1) does not apply to the manufacture or assembly of a POC investigational medicinal product to the extent that the manufacture or assembly is in accordance with the terms and conditions of a UK marketing authorisation or a marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC relating to that product. .
42 Insertion of new regulations 36A and 36B (manufacture of MM and POC investigational medicinal products)
After regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products) insert— Manufacture of MM investigational medicinal products 36A. (1) No person shall manufacture or assemble an MM investigational medicinal product unless— (a) the activity and product type is specified in a manufacturing authorisation (MM); and (b) there is an MM (IMP) master file relating to the product and the product is manufactured and assembled in accordance with that master file. (2) Paragraph (1) does not apply to the manufacture or assembly of an MM investigational medicinal product to the extent that the manufacture or assembly is in accordance with the terms and conditions of a UK marketing authorisation or a marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC relating to that product. Manufacture of POC investigational medicinal products 36B. (1) No person shall manufacture or assemble a POC investigational medicinal product unless— (a) the activity and product type is specified in a manufacturing authorisation (POC); and (b) there is a POC (IMP) master file relating to the product and the product is manufactured and assembled in accordance with that master file. (2) Paragraph (1) does not apply to the manufacture or assembly of a POC investigational medicinal product to the extent that the manufacture or assembly is in accordance with the terms and conditions of a UK marketing authorisation or a marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC relating to that product. .
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