The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
15 Amendment of regulation 39
(1) Regulation 39 (further requirements for manufacturer’s licence) is amended as follows. (2) In paragraphs (4) and (5), at the beginning insert “Except in the case of an MM medicinal product or a POC medicinal product,”. (3) After paragraph (5) insert— (5A) The holder of a manufacturer’s licence (MM) must ensure that the medicinal products specified in the licence are not handled, controlled, stored or distributed on any premises other than the MM control site and the modular units specified in the MM master file. (5B) The holder of a manufacturer’s licence (MM) must inform the licensing authority before making a material alteration to the premises or facilities at the MM control site, or to any modular unit specified in the MM master file, or to the purposes for which those premises or facilities are used. (5C) The holder of a manufacturer’s licence (POC) must ensure that the medicinal products specified in the licence are not handled, controlled, stored or distributed on any premises other than the POC control site and those specified in the POC master file. (5D) The holder of a manufacturer’s licence (POC) must inform the licensing authority before making a material alteration to the premises or facilities at the POC control site, or to the purposes for which those premises or facilities are used. (5E) Paragraphs (5A) and (5C) do not apply to anything done in the course of the business of a hospital that consists of dealing with a medicine or making it ready for use for the purposes of its final supply or administration to a patient. .
15 Amendment of regulation 39
(1) Regulation 39 (further requirements for manufacturer’s licence) is amended as follows. (2) In paragraphs (4) and (5), at the beginning insert “Except in the case of an MM medicinal product or a POC medicinal product,”. (3) After paragraph (5) insert— (5A) The holder of a manufacturer’s licence (MM) must ensure that the medicinal products specified in the licence are not handled, controlled, stored or distributed on any premises other than the MM control site and the modular units specified in the MM master file. (5B) The holder of a manufacturer’s licence (MM) must inform the licensing authority before making a material alteration to the premises or facilities at the MM control site, or to any modular unit specified in the MM master file, or to the purposes for which those premises or facilities are used. (5C) The holder of a manufacturer’s licence (POC) must ensure that the medicinal products specified in the licence are not handled, controlled, stored or distributed on any premises other than the POC control site and those specified in the POC master file. (5D) The holder of a manufacturer’s licence (POC) must inform the licensing authority before making a material alteration to the premises or facilities at the POC control site, or to the purposes for which those premises or facilities are used. (5E) Paragraphs (5A) and (5C) do not apply to anything done in the course of the business of a hospital that consists of dealing with a medicine or making it ready for use for the purposes of its final supply or administration to a patient. .
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