Regulation 31 Insertion of new Part 6AI1

After Part 6, insert—

“Part 6A

NON-INVESTIGATIONAL MEDICINAL AND NON-MEDICINAL PRODUCTS

Non-investigational medicinal and non-medicinal products

45A

(1)

A non-investigational medicinal product shall be manufactured or assembled in accordance with the principles and guidelines for good manufacturing practice which apply under these Regulations or the 2012 Regulations.

(2)

A product which is not a medicinal product but which is used or to be used in a clinical trial, as described in the protocol, must—

(a)

comply with safety standards applicable to that product; and

(b)

be listed in the investigational medicinal product dossier with information about its properties, labelling, manufacture and safety controls, appropriate to the product.”.