The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
4 Amendment of regulation 8
In regulation 8(1) (general interpretation), at the appropriate places insert— “manufacturer’s licence (MM)” means a manufacturer’s licence that relates to the manufacture or assembly of MM medicinal products specified in that licence; ; “manufacturer’s licence (POC)” means a manufacturer’s licence that relates to the manufacture or assembly of POC medicinal products specified in that licence; ; “MM” means modular manufacture; ; “MM control site” means the premises at which the holder of a manufacturer’s licence (MM) supervises and controls the manufacture or assembly of MM medicinal products; ; “MM master file” means a detailed description of the arrangements for the manufacture or assembly of an MM medicinal product; ; “MM medicinal product” means a medicinal product that, for reasons relating to deployment, the licensing authority determines it necessary or expedient to be manufactured or assembled in a modular unit; ; “modular unit” means a relocatable manufacturing unit; ; “POC” means point of care; ; “POC control site” means the premises at which the holder of a manufacturer’s licence (POC) supervises and controls the manufacture or assembly of POC medicinal products; ; “POC master file” means a detailed description of the arrangements for the manufacture or assembly of a POC medicinal product; ; “POC medicinal product” means a medicinal product that, for reasons relating to method of manufacture, shelf life, constituents or method or route of administration, can only be manufactured at or near the place where the product is to be used or administered; ; and “POC site” means a site at which the manufacture or assembly of a POC medicinal product takes place; .
4 Amendment of regulation 8
In regulation 8(1) (general interpretation), at the appropriate places insert— “manufacturer’s licence (MM)” means a manufacturer’s licence that relates to the manufacture or assembly of MM medicinal products specified in that licence; ; “manufacturer’s licence (POC)” means a manufacturer’s licence that relates to the manufacture or assembly of POC medicinal products specified in that licence; ; “MM” means modular manufacture; ; “MM control site” means the premises at which the holder of a manufacturer’s licence (MM) supervises and controls the manufacture or assembly of MM medicinal products; ; “MM master file” means a detailed description of the arrangements for the manufacture or assembly of an MM medicinal product; ; “MM medicinal product” means a medicinal product that, for reasons relating to deployment, the licensing authority determines it necessary or expedient to be manufactured or assembled in a modular unit; ; “modular unit” means a relocatable manufacturing unit; ; “POC” means point of care; ; “POC control site” means the premises at which the holder of a manufacturer’s licence (POC) supervises and controls the manufacture or assembly of POC medicinal products; ; “POC master file” means a detailed description of the arrangements for the manufacture or assembly of a POC medicinal product; ; “POC medicinal product” means a medicinal product that, for reasons relating to method of manufacture, shelf life, constituents or method or route of administration, can only be manufactured at or near the place where the product is to be used or administered; ; and “POC site” means a site at which the manufacture or assembly of a POC medicinal product takes place; .
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