The Medicines (Exemption from Licences) (Wholesale Dealing) Order 1989

• Citation: S.I. 1989/2322
• Sections: 3

Section 1 Title, commencement and interpretation

(1) This Order may be cited as the Medicines (Exemption from Licences) (Wholesale Dealing) Order 1989 and shall come into force on 1st January 1990.

(2) In this Order, unless the context otherwise requires –

“ the Act ” means the Medicines Act 1968;

“intermediate feed” means a medicated feeding stuff sold, supplied or imported for use wholly or mainly as an ingredient in the preparation of a substance which is to be fed to one or more animals for a medicinal purpose or for purposes that include that purpose, with or without further processing;

“medicinal product” includes:

substances or articles specified in Orders made under section 104 or section 105 of the Act which are for the time being in force and which direct that Part II of the Act shall have effect in relation to such substances or articles as that Part has effect in relation to medicinal products within the meaning of the Act;

articles or substances described in paragraphs 2 and 3 of Schedule 1 to the Medicines (Specified Articles and Substances) Order 1976 ; and

intermediate feed;

“proprietary medicinal product” and “ready-made veterinary drug” have the same meanings as in sections 7(7) and 8(4) of the Act

and other expressions have the same meaning as in the Act.

(3) Except in so far as the context otherwise requires, any reference in this Order to any enactment or Order shall be construed as a reference to that enactment or Order as the case may be amended or extended by any other enactment or Order.

Section 2 Exemption from wholesale dealer’s licences

(1) The restrictions imposed by section 8(3) of the Act (restrictions as to wholesale dealing) shall not apply to the sale or offer for sale of a medicinal product by way of wholesale dealing where such sale or offer for sale is either –

(a) by the holder of a product licence which relates to that medicinal product, including such holder of such product licence who is the person who assembled that medicinal product, or

(b) by a person who, not being the holder of such a product licence, assembled that medicinal product, where such assembly was to the order of a person who is the holder of such a product licence,

provided that throughout the period until such sale that medicinal product has not left the premises of any person who either manufactured or assembled that medicinal product being premises which by virtue of the relevant manufacturer’s licence the person who so manufactures or, as the case may be, assembles that medicinal product is enabled or authorised to use for the purposes of that licence (hereinafter in this article referred to as “the authorised premises”).

(2) For the purposes of this article a medicinal product shall not be regarded as having left the authorised premises whilst that medicinal product is being moved from any of the authorised premises to another, or from one part of the authorised premises to another part, or whilst it is being moved from any of the authorised premises by way of delivery to the purchaser.

(3) The restriction imposed by section 8(3)(b) of the Act (wholesale dealer’s licences) shall not apply in relation to anything done in relation to a proprietary medicinal product or a ready-made veterinary drug which has been imported when it is done by a person who handles the medicinal product –

(a) in the course of the provision of facilities solely for the transport of the medicinal product, or

(b) in the course of a business carried on by him as an import agent where he imports the medicinal product solely to the order of another person who intends, in the course of a business carried on by him, to sell, or offer for sale the medicinal product by way of wholesale dealing or in any other way intends to distribute the medicinal product.

Section 3 Revocation

The Medicines (Exemption from Licences) (Wholesale Dealing) Order 1972 , the Medicines (Exemption from Licences) (Wholesale Dealing) Order 1977 and the Medicines (Exemption from Licences) (Wholesale Dealing) Amendment Order 1983 are hereby revoked.