Regulation 36B Manufacture of POC investigational medicinal productsF1
No person shall manufacture or assemble a POC investigational medicinal product unless—
the activity and product type is specified in a manufacturing authorisation (POC); and
there is a POC (IMP) master file relating to the product and the product is manufactured and assembled in accordance with that master file.
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.
Annotations
Textual amendments
- F1
Regs. 36A, 36B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 42