S.I. No. 225/1974:

MEDICAL PREPARATIONS (LICENSING OF MANUFACTURE) REGULATIONS, 1974.

MEDICAL PREPARATIONS (LICENSING OF MANUFACTURE) 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 (Licensing of Manufacture) Regulations, 1974.

2. In these Regulations--

"the Minister" means the Minister for Health;

"batch" means a quantity which is homogeneous in character and quality produced during a given cycle of manufacture;

"manufacture" includes processing, compounding, formulating, filling, packaging and labelling;

"pharmacist" means a registered pharmaceutical chemist or a registered dispensing chemist and druggist;

"retail sale" means sale to a person buying otherwise than for the purpose of resale.

3. Subject to the exemptions specified in article 5 of these Regulations, no person shall manufacture for sale any medical preparation except in accordance with a licence granted by the Minister, referred to in these Regulations as a "manufacturer's licence".

4. A manufacturer'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.

5. Article 3 of these Regulations shall not apply to the manufacture of a medical preparation--

( a ) by or under the supervision of a registered medical practitioner or a registered dentist for one of his patients, or

( b ) by a registered veterinary surgeon for any animal under his care, or

( c ) by or under the supervision of a pharmacist in accordance with a prescription given by a registered medical practitioner, a registered dentist, or registered veterinary surgeon, or

( d ) by or under the supervision of a registered druggist in accordance with a prescription given by a registered veterinary surgeon, or

( e ) on a premises by or under the supervision of a pharmacist or registered druggist for the purpose of retail sale exclusively on those premises otherwise than in accordance with a prescription mentioned in sub-articles (c) and (d) of this article, or

( f ) on premises not exceeding three in number, by or under the supervision of a pharmacist or registered druggist for the purpose of maintaining a stock of a medical preparation for dispensing exclusively on any of those premises as mentioned in sub-articles (c), (d) or (e) of this article, or

( g ) by or under the supervision of a person in charge of a laboratory which is engaged in recognised medical, pharmaceutical, dental or veterinary education, research or analysis and used for such purposes in such a laboratory.

6. (1) The Minister may grant a manufacturer's licence to any person who applies in the form and manner required by the Minister who satisfies the Minister in regard to the medical preparation which he proposes to manufacture, that he has suitable premises, equipment, staff and manufacturing operations and suitable arrangements for quality control, record-keeping, handling, storage and distribution.

(2) A manufacturer'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 manufacture any medical preparation or class of medical preparation other than that to which the licence relates without prior approval of the Minister;

( b ) shall notify the Minister promptly of any material change in his premises, equipment, or manufacturing or quality control procedures, or of any change in the expert staff specified on his licence as in charge of manufacturing or quality control;

( c ) shall provide and maintain such premises, equipment and staff, and carry out such procedures as the Minister considers necessary and suitable for good manufacturing practice to meet the appropriate specifications of the medical preparation or medical preparations manufactured by him;

( d ) shall provide and maintain such premises, equipment and staff as are necessary for carrying out the appropriate tests of strength, quality and purity of the medical preparation or medical preparations manufactured by him, or shall make such other suitable arrangements for such tests as may be approved by the Minister;

( e ) shall keep available for at least five years from the date of manufacture or for one year from the expiry date of the medical preparation, whichever is the longer period, adequate records of the complete manufacturing history of each batch of a medical preparation manufactured by him and of the persons to whom each such batch or part thereof was supplied;

( f ) shall keep an adequate sample of each batch of a medical preparation manufactured by him for at least five years from the date of manufacture or for one year from the expiry date of the medical preparation, whichever is the shorter period, and shall furnish on request, without payment, a sample of each such batch;

( g ) shall, on being informed by the Minister that any part of any batch of a medical preparation manufactured by him 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 the remainder of that batch from sale and, so far as may be practicable, immediately recall all supplies already sold or distributed from that batch;

( h ) shall, on being informed by the Minister that a medical preparation to which his 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 any supplies of it already sold or distributed by him.

(3) The holder of a licence granted under sub-article (1) of this article shall from time to time permit such inspections and make available promptly on request such information as may be required to satisfy the Minister that the conditions of the licence continue to be fulfilled.

7. A manufacturer'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 £200 in respect of each manufacturer'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 licence, in accordance with sub-article (1) of this article, 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 October, 1975.

GIVEN under the Official Seal of the Minister for Health this 12th day

of July, 1974.

BRENDAN CORISH,

Minister for Health.

The Minister for Finance consents to article 8 of these Regulations. Dated this 12th day of July, 1974.

RICHIE RYAN,

Minister for Finance.

EXPLANATORY NOTE.

The effect of these Regulations is to prohibit the manufacture of medical preparations except under licence granted by the Minister for Health, with certain exemptions covering the day-to-day activities of medical practitioners, dentists and pharmacists in dispensing for individual patients.