S.I. No. 302/1975:

MEDICAL PREPARATIONS (LICENSING OF MANUFACTURE) (AMENDMENT) REGULATIONS, 1975.

MEDICAL PREPARATIONS (LICENSING OF MANUFACTURE) (AMENDMENT) REGULATIONS, 1975.

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. In these Regulations--

"the Principal Regulations" means the Medical Preparations (Licensing of Manufacture) Regulations, 1974 ( S.I. No. 225 of 1974 );

"qualified person" means a person as defined in the Schedule to these Regulations;

"the Minister" means the Minister for Health.

2. The provisions of the Principal Regulations in relation to manufacture for sale shall also apply to importation from countries other than Member States of the European Economic Community.

3. (1) Subject to the provisions of sub-article (2) of this article, the holder of a licence granted under article 6 of the Principal Regulations who is not himself a qualified person shall have permanently and continuously at his disposal the services of at least one qualified person.

(2) The holder of a licence who is a qualified person or the qualified person referred to in sub-article (1) shall be responsible for carrying out the duties specified in article 4 of these Regulations.

4. (1) Subject to the provisions of sub-article (2) of this article, the duties of the qualified person shall be

( a ) to ensure, in the case of a medical preparation manufactured within the State, that each batch thereof has been manufactured and checked in accordance with the conditions of any authorisation to place that preparation on the market granted under the European Communities (Proprietary Medicinal Products) Regulations, 1975 ( S.I. No. 301 of 1975 );

( b ) to ensure, in the case of a medical preparation coming from a country other than a Member State of the European Economic Community, that each batch of that preparation has undergone a full qualitative analysis, a quantitative analysis of at least all the active constituents and all the other tests or checks necessary to ensure the quality of a medical preparation, in accordance with the conditions of any authorisation granted under the European Communities (Proprietary Medicinal Products) Regulations, 1975, to place that medical preparation on the market;

( c ) to certify in a register or equivalent document provided for that purpose, which shall be kept up to date as operations are carried out and which shall be available for inspection for a period of not less than five years, that each production batch of a medical preparation satisfies the provisions of this article.

(2) Nothing in this article shall require the further checking of a batch of a medical preparation which has been manufactured and checked in another Member State of the European Economic Community where such batch is imported accompanied by control reports signed by a qualified person in such Member State.

5. (1) Subject to the provisions of sub-article (2) 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) 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.

6. (1) These Regulations may be cited as the Medical Preparations (Licensing of Manufacture) (Amendment) Regulations, 1975.

(2) These Regulations shall be construed as one with the Principal Regulations and may be cited with the Principal Regulations as the Medical Preparations (Licensing of Manufacture) Regulations, 1974 and 1975.

7. These Regulations shall come into operation on the 2nd day of February, 1976.

SCHEDULE.

A qualified person is a person who--

1. Fulfils the following minimum conditions of qualification:

( a ) possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognised as equivalent by the Minister, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology. However:

--the minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of a minimum duration of one year and including a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level;

--where two university courses or two courses recognised by the State in question as equivalent coexist in a Member State of the European Economic Community and where one of these extends over four years and the other over three years, the three-year course leading to a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course or its recognised equivalent shall be considered to fulfil the condition of duration referred to in this sub-paragraph in so far as the diploma certificates or other evidence of formal qualifications awarded on completion of both courses are recognised as equivalent by the State in question.

The course shall include theoretical and practical study bearing upon at least the following basic subjects and shall be so balanced as to enable the person concerned to fulfil the obligations specified in article 4 of these Regulations:

Applied physics

General and inorganic chemistry

Organic chemistry

Analytical chemistry

Pharmaceutical chemistry, including analysis of medicinal products

General and applied biochemistry (medical)

Physiology

Microbiology

Pharmacology

Pharmaceutical technology

Toxicology

Pharmacognosy (medical aspects) study of the composition and effects of the active principles of natural substances of plant and animal origin).

In so far as certain diplomas, certificates or other evidence of formal qualifications mentioned in the first paragraph do not fulfil the criteria laid down above, the person concerned shall provide evidence to the Minister of adequate knowledge of the subjects involved.

( b ) practical experience for at least two years, in one or more undertakings which are authorised to manufacture medical preparations, in the activities of qualitative analysis of medical preparations, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medical preparations provided that the duration of practical experience may be reduced by one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six years; or

2. was engaging in the activities of the person referred to in article 3 of these Regulations at the time the Regulations came into force; or

3. is the holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course--or a course recognised as equivalent by the Minister--in a scientific discipline allowing him to engage in the activities of the person referred to in article 3 of these Regulations, if he began his course prior to the commencement of these Regulations and provided that he has previously engaged in the following activities for at least two years before the end of the tenth year following the commencement of these Regulations in one or more authorised undertakings pursuant to article 6 of the Principal Regulations: production supervision and/or qualitative analysis, quantitative analysis of active substances, and the necessary testing and checking under the direct authority of the person referred to in article 3 to ensure the quality of the medical preparations;

(If the person concerned has acquired the practical experience referred to more than 10 years prior to the commencement of these Regulations, a further one year's practical experience in accordance with the conditions referred to will be required to be completed immediately before he engages in such activities); or,

4. who, at the time when these Regulations came into force, and for a period of five years thereafter, is engaged in direct collaboration with a person referred to in article 3 in production supervision activities and/or in qualitative and quantitative analysis of active substances and the testing and checking necessary to ensure the quality of the proprietary medicinal products, provided that the person shows evidence of adequate theoretical and practical knowledge and has engaged in the activities mentioned for at least five years.

GIVEN under the Official Seal of the Minister for Health this 15th day of December, 1975.

BRENDAN CORISH,

Minister for Health.

EXPLANATORY NOTE

The effect of these Regulations is to bring the provisions to be satisfied by manufacturers of medical preparations into line with the recently adopted EEC Council Directive 75/319 approximating the provisions of the various Member States in regard to the manufacture of such products. They require that there should be available a qualified person in each unit manufacturing medical preparations and specify duties and set down the qualifications and experience which such qualified person must possess. They also provide that the importation of medical preparations from countries other than Member States of the Community should be treated as manufacture for the purposes of the licensing of manufacture arrangements.