Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984.

• Jurisdiction: Ireland

S.I. No. 210 of 1984.

MEDICAL PREPARATIONS (LICENSING, ADVERTISEMENT AND SALE) REGULATIONS, 1984.

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) and by 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, Advertisement and Sale) Regulations, 1984. 2. (1) Subject to sub-article (2) these Regulations shall come into operation on the 1st day of October, 1984.

(2) Article 4 of these Regulations shall come into operation, in the case of each category of medical preparation specified in the first column of the Second Schedule, with effect from the commencement date specified in the third column of that Schedule in respect of each sub-category of such preparation specified in the second column thereof.

(3) A person who on the 1st day of October, 1984, in circumstances to which article 4 applies, is responsible for the sale of any medical preparation or for procuring the manufacture for sale of any medical preparation specified in sub-category (2) of category 2 of the Second Schedule shall by the 1st day of December, 1984 notify the Minister in respect of such preparation, giving the name of the preparation its dosage form and its active constituents in qualitative and quantitative terms. 3. (1) In these Regulations—

"the Act" means the Health Act, 1947 ;

"import" includes procure the importation, and cognate words shall be construed accordingly;

"the Minister" means the Minister for Health:

"manufacture" includes processing, compounding, formulating, assembling, filling, packaging, labelling and importing from countries other than Member States of the European Economic Communities;

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

"registered dentist" means a person registered in the register established under the Dentists Act. 1928 (No. 25 of 1928):

"registered dispensing chemist and druggist" means a person registered in the register of dispensing chemists and druggists established under the Pharmacy Act, 1951 (No. 30 of 1951);

"registered medical practitioner" means a person registered in the register established under the Medical Practitioners Act, 1978 (No. 4 of 1978):

"registered pharmaceutical chemist" means a person registered in the register of pharmaceutical chemists for Ireland established under the Pharmacy Act (Ireland), 1875:

"sell" includes distribute or offer or keep for sale or distribution or procure the sale or distribution, and cognate words shall be construed accordingly.

(2) In these Regulations any reference to an article or Schedule shall be construed as a reference to an article contained in these Regulations or as the case may be, to a Schedule thereto, any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article and any reference in a Schedule to a paragraph shall be construed as a reference to a paragraph of that Schedule. 4. (1) A person shall not. in the course of a business carried on by him and in the circumstances to which this article applies—

( a ) sell any medical preparation, or

( b ) procure the manufacture for sale of any medical preparation,

except in accordance with a licence granted or renewed by the Minister under these Regulations, hereinafter referred to as a "product authorisation".

(2) This article shall apply in each of the following circumstances:—

( a ) where the person selling the preparation or procuring the manufacture for sale of the preparation has imported the preparation;

( b ) where the person selling the preparation or procuring the manufacture for sale of the preparation is responsible for the composition of the preparation and has not imported the preparation.

(3) For the purposes of sub-article (2) (b) a person shall be taken to be responsible for the composition of a medical preparation where he either:—

( a ) manufactures the preparation to his own order or specification, or

( b ) procures, to his own order or specification, the manufacture of the preparation by another person.

(4) Subject to article 5 a person shall not import a medical preparation except in accordance with a product authorisation. 5. The provisions of article 4 shall not apply as respects:—

( a ) the sale of a medical preparation by a person lawfully keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons under the Pharmacy Acts, 1875 to 1977 where such sale is carried out and the preparation is extemporaneously compounded by or under the supervision of a pharmacist for such particular sale;

( b ) the importation or sale of a medical preparation by or to the order of a registered medical practitioner or registered dentist for the treatment of a patient under his care;

( c ) the importation of a medical preparation by any person for his own personal use, not being an importation resulting directly from a mail order advertisement directed to members of the public;

( d ) the importation or sale of a medical preparation solely for the purpose of its being exported. 6. (1) The Minister may grant or renew a product authorisation to any person who applies for such authorisation in accordance with article 7.

(2) A product authorisation shall be subject to the general conditions specified in the First Schedule to the Regulations and to such special conditions as may be specified in the authorisation.

(3) Unless sooner revoked by the Minister a product authorisation shall remain in force for a period of five years and may be renewed on application by the holder. 7. (1) An application for a product authorisation shall be made to the Minister and shall be in such form and be accompanied by the appropriate charge provided for under article 10 and by such information, documents, samples and other materials, as the Minister may require.

(2) An application for a product authorisation for a medical preparation in sub-category (2) of category 2 of the Second Schedule shall be made to the Minister at least twelve months before the commencement date applicable to medical preparations listed in the said sub-category.

(3) In the examination and determination of an application for a product authorisation the Minister shall take into consideration such criteria as appear to him to be relevant in the case of the application and, in particular, the information supplied by the applicant in relation to:—

( a ) the safety and efficacy of the medical preparation to which the application relates and the purpose for which the medical preparation is intended by the applicant to be administered, and

( b ) the quality of the medical preparation. 8. Where the applicant for a product authorisation is not the manufacturer of the medical preparation or where the medical preparation is to be imported into the State, the Minister may require the applicant to furnish a written undertaking in a form approved by the Minister and signed by or on behalf of the manufacturer of the preparation that in the event of the product authorisation being granted or renewed the manufacturer will comply with such conditions as may be specified in such undertaking and, in particular, that he will:—

( a ) permit the inspection by or on behalf of the Minister of the premises where the preparation is to be manufactured and of the operations to be carried out in the course of manufacture;

( b ) comply with any conditions relating to the manufacture of the preparation subject to which the authorisation is granted or renewed;

( c ) comply with any requirements imposed by or under the law of the country in which the preparation is to be manufactured. 9. (1) The Minister may refuse an application for a product authorisation where:—

( a ) the applicant fails to submit information, documents, samples or other materials in accordance with article 7 (1), or

( b ) the Minister is satisfied, following examination of such information, documents, samples or other materials that:—

(i) the information contained in or furnished in connection with the application is found to be incorrect in any material respect, or

(ii) the preparation is harmful under normal conditions of use, or

(iii) the therapeutic efficacy of the preparation is lacking or is insufficiently substantiated by the applicant, or

(iv) the qualitative or quantitative composition of the preparation to which the application relates is not as declared by the applicant.

(2) The Minister may revoke a product authorisation with the written consent of the holder thereof, or where he is satisfied that:—

( a ) the preparation to which the authorisation relates is harmful under normal conditions of use, or

( b ) the therapeutic efficacy of such preparation is lacking, or

( c ) the qualitative or quantitative composition of such preparation is not in accordance with the information declared by the holder, or

( d ) the controls on the preparation, or on any of its constituents, in the course of its manufacture as indicated in or in connection with the application or in compliance with any conditions subject to which the authorisation was granted or renewed have not been carried out, or

( e ) the requirements of the Medical Preparations (Licensing of Manufacture) Regulations, 1974 and 1975 have not been complied with, or

( f ) the information contained in or furnished in connection with the application for the authorisation is incorrect in any material respect, or

( g ) any condition subject to which the authorisation was granted or renewed has not been complied with. 10. A charge shall be paid to the Minister in respect of an application made to him pursuant to article...