Medicines Act 1975 · 2020 Revised Edition · Part 2 · Licences and Certificates Relating to Medicinal Products
6. Provisions as to manufacture and wholesale dealing
Feedback & supportThis section has effect without affecting section 5.
A person must not manufacture or assemble any medicinal product except in accordance with a licence granted for the purposes of this subsection (called in this Act a manufacturer’s licence).
manufacture
“manufacture”, in relation to a medicinal product, includes any process carried out in the course of making the product, but does not include dissolving or dispersing the product in, or diluting or mixing it with, some other substance used as a vehicle for the purpose of administering it;
A person must not sell any medicinal product by way of wholesale dealing except in accordance with a licence granted for the purposes of this subsection (called in this Act a wholesale dealer’s licence).
sell
“sell” includes barter, and also includes offering or attempting to sell, or receiving for sale, or having in possession for sale, or exposing for sale, or sending or delivering for sale, or causing or allowing to be sold, offered or exposed for sale, and “sale” and “sold” have corresponding meanings;
A manufacturer’s licence does not have effect so as to authorise the manufacture or assembly of medicinal products of any description for sale or supply to any other person, or for export, unless —
the holder of the licence is also the holder of a product licence which is applicable to medicinal products of that description; or
the products are manufactured or assembled to the order of a person who is the holder of such a product licence,and the products are manufactured or assembled in accordance with that product licence.