S.I. No. 333/1974:

MEDICAL PREPARATIONS (WHOLESALE LICENCES) REGULATIONS, 1974.

MEDICAL PREPARATIONS (WHOLESALE LICENCES) REGULATIONS, 1974.

The Minister for Health, in exercise of the powers conferred on him by sections 5 and 65 of the Health Act, 1947 (No. 28 of 1947), as amended by section 39 of the Health Act, 1953 (No. 26 of 1953), hereby makes the following Regulations :

1. These Regulations may be cited as the Medical Preparations (Wholesale Licences) Regulations, 1974.

2. In these Regulations--

"the Minister" means the Minister for Health;

"sale by wholesale" means sale or supply to a person for the purposes of resale or for administration to patients in the course of a business or profession conducted by that person or for a hospital, clinic or similar institution.

3. Subject to the exemptions provided for in article 4 of these Regulations, no person shall sell any medical preparation by wholesale except in accordance with a licence (hereinafter called a wholesaler's licence) granted by the Minister.

4. (1) The provisions of article 3 of these Regulations shall not apply to--

( a ) the 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, 1974 ( S.I. No. 225 of 1974 ), 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 these 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.

5. 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.

6. (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 not sell by wholesale any medical preparation other than those to which the licence relates,

( b ) 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,

( c ) shall, on being informed by the Minister or the manufacturer that any batch or part of a batch of a medical preparation to which the licence relates has been found not to conform as regards strength, quality or purity with the appropriate specification of that medical preparation, if so directed by the Minister, immediately withdraw from sale any supplies of that batch held by him and immediately recall all supplies already sold or distributed from that batch,

( d ) shall, on being informed by the Minister that a medical preparation to which the licence relates has been found to give rise to unacceptable adverse reactions, if so directed by the Minister, immediately withdraw any supplies held by him of that medical preparation from sale and, so far as may be practicable, immediately recall all supplies of it already sold or distributed by him,

( e ) shall keep available records, and, in particular, such records as may be specified in the licence, of the distribution of the medical preparation sold by him as will facilitate its withdrawal or recall as mentioned in paragraphs (c) and (d) of this sub-article.

(3) The holder of a licence granted under sub-article (1) of this article shall--

( a ) from time to time, permit such inspections and make available such information as may be required to satisfy the Minister that the conditions of the licence are being complied with, and

( b ) give without payment, an adequate sample of the medical preparation to any person authorised to take such a sample.

7. A wholesaler's licence shall remain in force for a period of three years, or such shorter period as may be specified in the licence, unless it is sooner revoked by the Minister.

8. There shall be paid to the Minister an annual fee of £50 in respect of each wholesaler's licence.

9. (1) The Minister may refuse to grant an application for a licence under these Regulations or he may revoke a licence already granted.

(2) If the Minister proposes to refuse or to revoke a wholesaler's licence, he shall notify the applicant or the holder as the case may be, of the reasons for such proposal and invite him to make representations in the matter to him within one month of the giving of such notice, and the Minister shall consider any such representations.

(3) The Minister shall inform the applicant or licence holder in writing of his decision regarding such proposed refusal or revocation as mentioned in sub-article (2) of this article within two months of the notice referred to in that sub-article.

10. These Regulations shall be enforced and executed by officers of the Minister.

11. These Regulations shall come into operation on the 1st day of January, 1976.

GIVEN under the Official Seal of the Minister for Health this 19th day of

November, 1974.

BRENDAN CORISH,

Minister for Health.

The Minister for Finance consents to article 8 of these Regulations.

Dated this 19th day of November, 1974.

RICHIE RYAN,

Minister for Finance.

EXPLANATORY NOTE.

The effect of these Regulations is to prohibit the sale or supply of medical preparations by wholesale except under licence granted by the Minister for Health, with certain exceptions.