S.I. No. 439/1994:

MEDICAL PREPARATIONS (LICENSING, ADVERTISEMENT AND SALE) (AMENDMENT) REGULATIONS, 1994.

MEDICAL PREPARATIONS (LICENSING, ADVERTISEMENT AND SALE) (AMENDMENT) REGULATIONS, 1994.

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), section 36 of the Misuse of Drugs Act, 1977 (No. 12 of 1977) and by section 7 of the Health (Family Planning) (Amendment) Act, 1992 (No. 20 of 1992) hereby makes the following Regulations:--

1. (1) These Regulations may be cited as the Medical Preparations (Licensing, Advertisement and Sale) (Amendment) Regulations, 1994.

(2) These Regulations shall be construed as one with the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 ( S.I. No. 210 of 1984 ) (hereinafter referred to as "the Principal Regulations"), the Medical Preparations (Licensing, Advertisement and Sale) (Amendment) Regulations, 1989 ( S.I. No. 347 of 1989 ) and the Medical Preparations (Licensing, Advertisement and Sale) (Amendment) Regulations, 1993 ( S.I. No. 70 of 1993 ) and may be cited together with those Regulations as the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 to 1994.

2. These Regulations, other than article 3 (c) shall come into operation on the 1st day of October, 1995 and the said article 3 (c) of the regulations shall come into operation on the 1st day of January, 1995.

3. The Principal Regulations are hereby amended by:--

( a ) the insertion of the following definitions in sub-article (1) of Article 3--

"'certificate of registration' means a certificate issued under article 6A;";

"'homoeopathic medical preparation' means any medical preparation prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described in the European Pharmacopoeia or, in the absence of a manufacturing procedure for homeopathic medical preparations in that pharmacopoeia, in accordance with a homeopathic manufacturing procedure in any pharmacopoeia in official use in a Member State of the European Communities;".

( b ) the insertion in article 3 of the following new sub-article--

"(3) In these Regulations, except in article 6, every reference to a product authoristion shall include reference to a certificate of registration issued under article 6A.".

( c ) the substitution of the following sub-article for sub-article (1) of article 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 manufcture 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' 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)."

( d ) the insertion after article 6 of the following new article--

"6A (1) the Minister may grant or renew a certificate of registration in respect of any homeopathic medical preparation which satisfies the conditions set our in sub-article (2) to any person who makes application in writing for such certificate in accordance with article 7 (1) and for such purpose the information, documents, samples and other materials required by the Minister shall be as specified in the fourth Schedule.

(2) Subject to sub-article (3), the conditions to be met for the purposes of registration under sub-article (1) are that the homeopathic medical preparation 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 preparation or in any information relating thereto; and

(iii) there is a suficient degree of dilution to guarantee safety.

the homeopathic medical preparation shall not be considered to have a suficient degree of dilution to guarantee its safety if--

(i) in the case of a medical preparation containing an active principle the presence of which in an allopathic medical preparation would, by virtue of the Medical Preparations (Prescription and Control of supply) Regulations, 1993 ( S.I. No. 69 of 1993 ), require the presentation of a prescription issued by a registered medical practitioner in order that the sid preparation may be supplied, if it contains either more than one part per 10,000 of the mother tincture or nmore than one-hundredth of the smallest dose of the said active principle as used in allopathy, or

(ii) in any other case, if it contains more than one part per 10,000 of the mother tincture.

(4) The registration referred to in sub-article (1) shall be subject to the conditions specified in the Fifth Schedule.

(5) Unless sooner revoked by the Minister, the aforementioned registration shall remain in force for a period of five years and may be renewed on application made by the holder thereof in the manner provided for in sub-article (1) not later than three months before the date of expiry of the certificate concerned.

(6) (i) The provisions of articles 7, 8 and 9 shall apply to the homeopathic medical preparations to which this article relates as if the references in those articles to efficacy and therapeutic efficacy had been omitted.

(ii) Subparagraph (v) of article 9 (1) (b) (as inserted by article 2 (b) of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1993 ( S.I. No. 70 of 1993 ) ) shall not apply to a homeopathic medical preparation to which this article applies.".

( d ) the deletion of paragraph (a) in article 12;

( e ) the insertion after the Third Schedule of the following two new Schedules--

"FOURTH SCHEDULE

Information, Samples, Documents and other Materials Required in Applications for Certificates of Registration

1. The name and permanent address of--

( a ) the person responsible for placing the product on the market in Ireland; and

( b ) the manufacture and the locations involved in the different stages of manufacture. Such shall include the manufacturers of the homeopathic stock or stocks and of the finished product;

2. Details of the scientific name or other name in a pharmacopoeia of the homeopathic stock or stocks;

3. A statement of the various routes of administration, pharmaceutical forms and the degree of dilution to be registered;

4. A dossier describing how the homeopathic stock or stocks is or are to be obtained and controlled and justifying its or their homeopathic nature on the basis of an adequate bibliography;

5. A manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation;

6. A copy of the manufacturers licence held under Article 7 (1) of the Medical Preparations (Licensing of Manufacture) Regulations, 1993 ( S.I. No. 40 of 1993 ) (as amended), or a corresponding manufacturing authorisation granted in another Member State of the European Communities in respect of the homeopathic medical preparation concerned;

7. Copies of any registrations or authorisations obtained for the same homeopathic medical preparation in another Member State of the European Communities;

8. One or more specimens or mock-ups of the sales presentation of the homeopathic medical preparation to be registered; and

9. Data concerning the stability of the homeopathic medical preparation concerned."; and

"FIFTH SCHEDULE

Conditions subject to which homeopathic medical preparations are registered under article 6A.

1. The holder of the certificate of registration (hereinafter referred to as the registration holder) shall report to the Minister any change in his name and address an in any address at which there is carried on a business to which the registration relates.

2. The registration holder shall ensure that any preparation to which the registration relates is manufactured only in accordance with the methods set out in, or furnished in connection with, his application for registration and that the specifications of the constituents and of the finished preparation are in accordance with the information contained in, or furnished in connection with the said application except in so far as may otherwise be approved by the Minister.

3. The registration holder shall inform the Minister of any material change that has been made, or is proposed to be made in the particulars contained in or furnished in connection with his application, in relation to any preparation to which the registration relates, that is to say--

( a ) in the composition of the preparation, or of any of its constituents,

( b ) in the specification of the preparation or of any of its constituents,

( c ) in the methods of manufacture of the preparation or of any of its constituents,

( d ) in the methods and procedures described in the application for ensuring compliance with such specifications,

( e ) in the arrangements described in the application for storge of the preparation,

( f ) in the route(s) of administration or in the dosage schedules, or

( g ) in the method of retail sale or supply.

4. The registration holder shall keep a record of reports of adverse effects associated with the use of the preparation to which the registration relates. The record shall be available for inspection by a person authorised by the Minister who may take copies thereof. The registration holder shall furnish to the Minister a copy of any such report of which he has a record or of which he is aware.

5. The registration holder shall keep available for inspection by a person authorised by the Minister durable records of his arrangements--

( a ) for obtaining materials for the purpose of the manufacture by him or on his behalf of any preparation to which the registration relates, and

( b ) for procuring the manufacture, importation, storage, sale or supply of any such preparation, and

( c ) for the tests to be carried out on any such preparation or on the materials used for its manufacture

and shall permit the person so authorised to take copies of, or to make extracts from, such records. The records shall be retained for a period of five years from the date on which the relevant batch of the preparation was released for sale.

6. The registration holder shall keep such documents as will facilitate the withdrawal or recall from sale or supply of any preparation to which the registration relates.

7. (1) The registration holder, on being informed by the Minister that any preparation to which the registration relates has been found--

( a ) to be harmful under normal conditions of use, or

( b ) not to be in accordance with the information contained in or furnished in connection with the application for such registration, or furnished in compliance with any of the conditions set out in this Schedule, as regards the qualitative or quantitative composition of the preparation,

shall, if so directed by the Minister, withhold from sale all batches of the preparation or such batch as may be specified by the Minister, and so far as may reasonably be practicable, immediately recall all supplies of the preparation or of such batch of the preparation as has already been issued.

(2) The registration holder shall comply with the conditions set out in sub-paragraph (1) where the controls on the preparation to which registration relates, or on any of its constituents, in the course of its manufacture as indicated in or in connection with his application for the product registration or in compliance with the conditions set out in this Schedule, have not been carried out.

8. The registration holder shall notify the Minister of any decision to withdraw from sale or supply any preparation to which the registration relates and shall state the reason for that decision.

9. The registration holder shall ensure--

( a ) that the preparation to which the registration relates is not sold unless it has been manufactured in the premises in respect of which any undertaking has been given pursuant to article 8.

( b ) that such preparation has been manufactured in such premises and in such circumstances as to comply with any conditions specified in such undertaking.

10. The registration holder shall in the event of the registration being revoked surrender it to the Minister.".

GIVEN under the Official Seal of the Minister for Health this 20th

day of December, 1994.

MICHAEL NOONAN,

Minister for Health

EXPLANATORY NOTE.

These regulations amend the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 ( S.I. no. 210 of 1984 ) so as to give effect to--

(1) EC Council Directive 92/73/EEC of 22 September 1992 (O.J. No. L297 of 13.10.91) widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down additional provisions on homeopathic medicinal products.

(2) EC Council Regulation No. (EEC) 2309/93 of 22 July 1993 (O.J. No. L214 of 24.8.93) with particular regard to licences for medicinal products for human use granted in accordance therewith.