# The Medicines for Human Use (Clinical Trials) Regulations 2004, Regulation 36: Requirement for authorisation to manufacture or import investigational medicinal products


(1) Subject to paragraph (2) and regulations 37 and 37A, no person shall manufacture, assemble or import any investigational medicinal product except in accordance with an authorisation of the appropriate type granted by the licensing authority for the purposes of this regulation (“a manufacturing authorisation”).
(1A) For the purposes of paragraph (1), the appropriate type of authorisation is an authorisation that relates to whichever, or whichever combination, of the following that is appropriate—
(a) manufacture or assembly of investigational medicinal products, except for MM investigational medicinal products and POC investigational medicinal products;
(b) import of investigational medicinal products, except for MM investigational medicinal products and POC investigational medicinal products;
(c) manufacture or assembly of MM investigational medicinal products;
(d) manufacture or assembly of POC investigational medicinal products.
(2) The restriction in paragraph (1) shall not apply to the manufacture or assembly of a medicinal product to the extent that such manufacture or assembly is in accordance with the terms and conditions of a marketing authorization or marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC relating to that product.
(3) Regulation 36A sets out additional requirements in relation to the manufacture and assembly of MM investigational medicinal products.
(4) Regulation 36B sets out additional requirements in relation to the manufacture and assembly of POC investigational medicinal products.

---
Source: https://www.legislation.gov.uk/uksi/2004/1031/regulation/36 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-36
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.