The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

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

(2) In subsection (2)—

(a) for “subsection (2A)” substitute “subsections (2A) and (2C)”;

(b) for “manufacture or assemble”, substitute “manufacture, assemble or import from a third country”.

(3) After subsection (2B), insert—

“(2C) The prohibition in subsection (2) does not apply to a person who, in connection with the importation of a medicinal product from a third country—

(a) provides facilities solely for transporting the product, or

(b) in the course of a business carried on by him as an import agent, imports the medicinal product solely to the order of another person who holds a manufacturer’s licence authorising the importation of the product.

(2D) The Ministers may prescribe requirements (either generally or in relation to a prescribed class of medicinal product or activity)—

(a) with which the holder of a manufacturer’s licence must comply, and

(b) which are to have effect as if they were provisions of the licence.”.

(4) After subsection (3D), insert—

“(3E) The Ministers may prescribe requirements (either generally or in relation to a prescribed class of medicinal product or activity)—

(a) with which the holder of a wholesale dealer’s licence must comply, and

(b) which are to have effect as if they were provisions of the licence.”.

(1)

Section 8 was amended by S.I. 1977/1050, 1992/604/ 1993/834, 2002/236 and 2004/1031.