Medical Preparations (Licensing of Manufacture) Regulations, 1993

• Jurisdiction: Ireland
• Year: 1993
• Citation: IR SI 40/1993

S.I. No. 40 of 1993.

MEDICAL PREPARATIONS (LICENSING OF MANUFACTURE) 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 (Licensing of Manufacture) Regulations, 1993. 2. The Medical Preparations (Licensing of Manufacture) Regulations, 1974 ( S.I. No. 225 of 1974 ) and the Medical Preparations (Licensing of Manufacture) (Amendment) Regulations, 1975 ( S.I. No. 302 of 1975 ) are hereby revoked. 3. 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:

—total and partial manufacture,

—the various processes of dividing up, packaging or presentation,

—formulation, processing, compounding or filling, and

—the importation of a medical preparation from a country other than a Member State of the European communities;

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

"product authorisation" means a product authorisation granted under the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 ( S.I. No. 210 of 1984 ) as amended by the Medical Preparations (Licensing, Advertisement and Sale) (Amendment) Regulations, 1989 ( S.I. No. 347 of 1989 );

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

"qualified person" means a person as defined in Schedule 11 to these Regulations. 4. Subject to the exemptions specified in article 6 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". 5. 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. 6. Article 4 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 sales 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 these 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. 7. (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 arrangement for quality controls, 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, include the General Conditions set out in Schedule I. 8. 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. 9. There shall be paid ot he Minister an annual fee of £1,250 in respect of each manufacturer's licence. 10. (1) Subject to the provisions of sub-article (4) of this article the Minister shall, within 90 days of the receipt of the application, notify an applicant for a manufacturer's licence of his decision to grant or his proposal to refuse such licence.

(2) If the Minister proposes to refuse a licence, in accordance with sub-article (1) of this article he shall notify the applicant of the reasons for such proposal and invite him to make representations in the matter to him within 30 days of the giving of such notice and the Minister shall consider any such representations.

(3) The Minister shall inform the applicant in writing of his decision regarding such proposed refusal as mentioned in sub-article (2) of this article within 60 days of the notice referred to in that sub-article.

(4) Where the Minister requires further information from the applicant for the purpose of consideration of the application for a manufacturer's licence, the time limit referred to in sub-article (1) of this article shall be suspended until the information required has been supplied.

(5) The Minister may revoke a licence already granted under these regulations.

(6) If the Minister proposes to revoke a licence, in accordance with sub-article (5) of this article, he shall notify the holder of the reasons for such proposal and invite him to make representations in the matter to him within 30 days of the giving of such notice and the Minister shall consider any such representations.

(7) The Minister shall inform the licence holder in writing of his decision regarding such proposed revocation as mentioned in sub-article (6) of this article within 60 days of the notice referred to in that sub-article. 11. These Regulations shall be...