The Medicines Act 1968 (Amendment) Regulations 1993

Section 8 of the Act—manufacture and wholesale dealing

2.—(1) Section 8 of the Act (provisions as to manufacture and wholesale dealing) is amended as follows.

(2) At the beginning of subsection (3) there is inserted “Subject to subsection (3C) of this section,”.

(3) In subsection (3) for the words from “licence granted” onwards there is substituted “wholesale dealer’s licence”.

(4) After that subsection there is inserted—

“(3A) Without prejudice to the generality of subsection (3) of this section but subject to subsection (3C), no person shall, in the course of a business carried on by him, distribute by way of wholesale dealing a product to which Chapters II to V of the 1965 Directive apply except in accordance with a wholesale dealer’s licence.

(3B) Distribution of such a product by way of wholesale dealing shall not be taken to be in accordance with a wholesale dealer’s licence unless, in particular, it occurs in the course of a business which is carried on at a place or places specified in the licence.

(3C) The restrictions imposed by subsections (3) and (3A) of this section do not apply to anything done in relation to a product to which Chapters II to V of the 1965 Directive apply by the holder of a manufacturer’s licence in respect of it.”.

(5) After subsection (6) there is added—

“(7) In this section any reference to distribution of a product by way of wholesale dealing is a reference to—

(a) selling or supplying it, or

(b) procuring, holding or exporting it for the purposes of sale or supply,

to a person who receives it for the purposes of—

(i) selling or supplying it, or

(ii) administering it or causing it to be administered to one or more human beings,

in the course of a business carried on by that person.

(8) In this Act any reference to a wholesale dealer’s licence is a reference to a licence granted for the purposes of subsection (3) or (3A) of this section.”.