Medicinal Products (Licensing and Sale) Regulations, 1998

• Jurisdiction: Ireland
• Year: 1998
• Citation: IR SI 142/1998

S.I. No. 142 of 1998.
MEDICINAL PRODUCTS (LICENSING AND SALE) REGULATIONS, 1998
The Minister for Health and Children, in exercise of the powers conferred on him by Section 32 of the Irish Medicines Board Act, 1995 (No. 29 of 1995), hereby makes the following Regulations:—
	1 Citation	1. These Regulations may be cited as the Medicinal Products (Licensing and Sale) Regulations, 1998.
	2 Interpretations	2. (1) In these Regulations —
"the Act" means the Irish Medicines Board Act, 1995 ;
"the Board" means the Irish Medicines Board;
"certificate of registration" means a certificate issued under Article 8;
"homoeopathic medicinal product" means any medicinal product prepared from preparations, substances or compositions called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described in the European Pharmacopoeia or, in the absence of a manufacturing procedure for homoeopathic medicinal products in that pharmacopoeia, in accordance with a homoeopathic manufacturing procedure in any pharmacopoeia in official use in a Member State of the European Communities;
"import" includes procure the importation, and cognate words shall be construed accordingly;
"the Minister" means the Minister for Health and Children;
"manufacture" includes:
— total and partial manufacture,
— the various processes of dividing up, packaging or presentation,
— assembling, compounding, filling, formulation, labelling, packaging, processing, and or
— the importation of a medicinal product 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 licence granted or renewed by the Board in accordance with Article 7 of these regulations;
"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;
"retail sale" means sale to a person buying otherwise than for the purpose of resale;
"sale by wholesale" means sale or supply for the purposes of sale in the course of a business or for administration to patients in the course of a professional practice and cognate words shall be construed accordingly;
"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 and 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.
(3) In these Regulations, except in article 7, every reference to a product authorisation shall include reference to a certificate of registration issued under article 8.
	3 Requirement that medicinal products be licensed	3. (1) Subject to article 4, a person shall not, in the course of a business carried on by him
(a) import, place on the market or otherwise sell any medicinal product, or
(b) procure the manufacture for sale of any medicinal product,
except such product is the subject of a licence granted or renewed by the Board under these Regulations, hereinafter referred to as a "product authorisation" or an authorisation granted or renewed in accordance with Council Regulation No. (EEC) 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of medicinal products (OJ No. L214 of 24 August, 1993) (hereinafter referred to as a marketing authorisation) and such importation, placing on the market or sale is in accordance with the terms of such product authorisation or marketing authorisation as the case may be.
	4 Exemptions from the requirement that medicinal products be licensed	4. The provisions of article 3 shall not apply as respects —
(a) the sale of a medicinal product 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 product is extemporaneously compounded by or under the supervision of a pharmacist for such particular sale;
(b) the importation or sale of a medicinal product 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 medicinal product 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 medicinal product solely for the purpose of its being exported;
(e) the manufacture or importation of a medicinal product which is intended for use in the conducting of a clinical trial, in accordance with a permission granted under section 4 of the Control of Clinical Trials Act, 1987 (No. 28 of 1987).
	5 Applications and criteria of assessment for the grant of product authorisations	5. (1) An application for a product authorisation shall be made to the Board and shall be in such form and be accompanied by such information, documents, samples and other materials, as the Board may require in accordance with the provisions of Council Directives 65/65/EEC (O.J.No.22 of 9.2.65), 75/318/EEC (O.J.No.L147 of 9.6.75) and 75/319/EEC (O.J.No.L147 of 9.6.75), as amended, together with the appropriate fee provided for under article 11.
(2) In the examination and determination of an application for a product authorisation the Board shall take into consideration such criteria as appear 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 medicinal product to which the application relates and the purpose for which the medicinal product is intended by the applicant to be administered, and
(b) the quality of the medicinal product.
	6 Applicant other than manufacturer	6. Where the applicant for a product authorisation is not the manufacturer of the medicinal product or where the medicinal product is to be imported into the State, the Board may require the applicant to furnish a written undertaking in a form approved by the Board and signed by or on behalf of the manufacturer of the product 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 Board of the premises where the product 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 product 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 product is to be manufactured.
	7 Product authorisations	7. (1) The Board may grant or renew a product authorisation to any person who applies for such authorisation in accordance with Article 5.
(2) A product authorisation granted under this article shall:—
(a) incorporate a summary of product characteristics containing the information set out in Part I of the First Schedule to these Regulations, and
(b) be subject
(i) to the general conditions specified in Part II of the said First Schedule, and
(ii) to the special conditions, if any, specified in the product authorisation.
(3) Unless sooner revoked by the Board a product authorisation shall normally remain in force for a period of five years and may be renewed on application made by the holder thereof not later than three months before the date of expiry of the authorisation concerned.
	8 Homeopathic medicinal product	8. (1) The Board may grant or renew a certificate of registration in respect of any homoeopathic medicinal product which satisfies the conditions set out in sub-article (2) to any person who makes application in writing for such certificate and for such purpose the information, documents, samples and other material required by the Board shall be as specified in the Third Schedule.
(2) Subject to sub-article (3), the conditions to be met for the purpose of registration under sub-article (1) are that the homoeopathic medicinal product shall be such that-
(i) it is intended to be administered orally or externally;
(ii) no specific therapeutic indication appears on the labelling of the product or in any information relating thereto; and
(iii) there is a sufficient degree of dilution to guarantee safety.
(3) The homoeopathic medicinal product shall not be considered to have a sufficient degree of dilution to guarantee safety if -
(i) in the case of a medicinal product containing an active principle the presence of which in an allopathic medicinal product would, by virtue of the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 (S.I. Nos. 256 and 309 of 1993), require the presentation of a prescription issued by a registered medical practitioner in order that...