After regulation 17 (manufacturing of medicinal products) insert—

“Manufacturing of MM medicinal products17A.

A person may not manufacture or assemble an MM medicinal product unless—

(a)

it is specified in a manufacturer’s licence (MM); and

(b)

there is an MM master file relating to that product and it is manufactured or assembled in accordance with that master file.

Manufacturing of POC medicinal products17B.

A person may not manufacture or assemble a POC medicinal product unless—

(a)

it is specified in a manufacturer’s licence (POC); and

(b)

there is a POC master file relating to that product and it is manufactured or assembled in accordance with that master file.”.