Medical Preparations (Wholesale Licences) Regulations, 1993

• Jurisdiction: Ireland
• Citation: IR SI 39/1993
• Year: 1993

S.I. No. 39 of 1993.

MEDICAL PREPARATIONS (WHOLESALE LICENCES) REGULATIONS, 1993.

The Minister for Health, in exercise of the powers conferred on him by section 5 of the Health Act, 1947 (No. 28 of 1947) and section 65 of that Act as amended by section 39 of the Health Act, 1953 (No. 26 of 1953) and section 36 of the Misuse of Drugs Act, 1977 (No. 12 of 1977), hereby makes the following Regulations:— 1. These Regulations may be cited as the Medical Preparations (Wholesale Licences) Regulations, 1993. 2. The Medical Preparations (Wholesale Licences) Regulations, 1974 ( S.I. No. 333 of 1974 ), are hereby revoked. 3. In these Regulations—

" the Minister" means the Minister for Health;

"sale by wholesale" means sale or supply for the purposes of sale in the course of a business or for administration to patients in the course of a professional practice and cognate words shall be construed accordingly. 4. Subject to the exemptions provided for in article 5 of these Regulations, no person shall keep or offer for sale by wholesale or sell by wholesale, any medical preparation except in accordance with a licence (hereinafter called a wholesaler's licence) granted by the Minister. 5. (1) The provisions of article 4 of these Regulations shall not apply to—

( a ) the sale or supply or the keeping or offering for sale or supply of a medical preparation by a person who has manufactured it in accordance with a manufacturer's licence held by him under the Medical Preparations (Licensing of Manufacture) Regulations, 1993 ( S.I. No. 40 of 1993 ), or

( b ) the sale by retail of a medical preparation to a registered medical practitioner or a registered dentist for administration to his patients, or

( c ) arrangements for the distribution of medical preparations amongst themselves by one member of a group of persons not exceeding three in number who co-operate in the purchase by wholesale of those medical preparations.

(2) "Person" for the purposes of paragraph (c) of sub-article (1) of this article means a registered pharmaceutical chemist, a registered dispensing chemist and druggist or a registered druggist. 6. A wholesaler's licence may relate to medical preparations generally, to medical preparations of a class or description specified in such licence or to one or more medical preparations specified in such licence. 7. (1) The Minister may grant a wholesaler's licence to any person who applies in the form and manner required by the Minister and who satisfies the Minister in regard to the medical preparation or preparations which he proposes to sell by wholesale, that he has suitable premises, equipment and staff and suitable arrangements for record-keeping, handling, storage and distribution.

(2) A wholesaler's licence granted under sub-article (1) of this article shall be subject to such conditions as the Minister may specify and may, in particular, require that the holder of the licence—

( a ) shall supply a medical preparation only to a person who is in possession of a licence as referred to in sub-article (1) of this article or to a person carrying on a business of shopkeeping provided he has reasonable grounds for believing that the person is a person entitled to sell the medical preparation under and in accordance with the provisions of the Medical Preparations (Licensing, Advrtisement & Sale) Regulations, 1984 and 1989 ( S.I. No. 210 of 1984 and S.I. No. 347 of 1989 ) or the Poisons Regulations, 1982 ( S.I. No. 188 of 1982 ) as amended.

( b ) shall not sell by wholesale or keep or offer for sale by wholesale

(i) any medical preparation other than those to which the licence relates,

(ii) any medical preparation which requires a product authorisation under the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 and 1989 ( S.I. No. 210 of 1984 and S.I. No. 347 of 1989 ) and which is not the subject of such an authorisation for the time being in force,

(iii) any medical preparation otherwise than in conformity with the provisions of the aforementioned product authorisation,

( c ) shall provide and maintain such premises, equipment and staff, and have in operation such arrangements as are necessary to avoid deterioration of the medical preparation to which the licence relates and shall notify the Minister promptly of any material change in such premises, equipment, staff or arrangements,

( d ) shall undertake proceudres for storage, stock turnover and maintenance of records which are in compliance with the particulars furnished in connection with the application for the licence or with such other arrangements as may be approved by the Minister from time to time,

( e )...