S.I. No. 440/1994:

MEDICAL PREPARATIONS (LABELLING AND PACKAGE LEAFLETS) (AMENDMENT) REGULATIONS, 1994.

MEDICAL PREPARATIONS (LABELLING AND PACKAGE LEAFLETS) (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 (Labelling and Package Leaflets) (Amendment) Regulations, 1994.

(2) These Regulations shall be construed as one with the Medical Preparations (Labelling and Package Leaflets) Regulations, 1993 ( S.I. No. 71 of 1993 ) (hereinafter referred to as "the Principal Regulations") and may be cited together with those Regulations as the Medical Preparations (Labelling and Package Leaflets) Regulations, 1993 and 1994.

2. These Regulations shall come into operation on the 1st day of October, 1995.

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

( a ) the insertion of the following definitions in sub-article (1) of Article 2--

"'certificate of registration' means a certificate issued under article 6A of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 ( S.I. No. 210 of 1984 ) as amended;";

'"homeopathic 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;"; and

'"manufacturer' means the holder of the authorisation referred to in Article 16 of Council Directive 75/319/EEC (as amended) on behalf of whom the Qualified Person referred to therein has performed the specific obligations laid down in Article 22 of the said Directive;"

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

"6A. (1) The particulars which shall appear in clear and legible form on the containers and packages of a homeopathic medical preparation in respect of which a certificate of registration is granted shall be those set out in Schedule 3 and no other particulars.

(2) Any package leaflet which is enclosed in or supplied with a homeopathic medical preparation as aforesaid shall show in clear and legible form the particulars set out in Schedule 3 and no other particulars.

(3) Articles 4, 5, 7, 8, 9, 10 and 11 shall not apply to any homeopathic medical preparation to which this article applies.".

( c ) the insertion after Schedule 2 of the following new Schedule-

"SCHEDULE 3

Particulars required to appear on the containers, packages and on the package leaflets of homeopathic medical preparations.

( a ) the words 'homeopathic medicinal product';

( b ) the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia containing the description of the relevant homeopathic manufacturing procedure used for the manufacture of the preparation concerned;

( c ) the name and address of the person responsible for placing the product on the market and, where appropriate, of the manufacturer;

( d ) the method of administration and, where appropriate, the route of administration;

( e ) the expiry date stating the month and year;

( f ) the pharmaceutical form;

( g ) the contents of the sales presentation;

( h ) any special storage precautions;

( i ) any special warnings necessary for the medical preparation concerned;

( j ) the manufacturer's batch number;

( k ) the registration number specified in the certificate of registration;

( l ) the words 'homeopathic medical product without approved therapeutic indications';

( m ) a warning advising the user to consult a doctor if the symptoms persist during the use of the medical preparation.".

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

of December, 1994.

MICHAEL J. NOONAN,

Minister for Health.

EXPLANATORY NOTE.

These Regulations amend the Medical Preparations (Labelling and Package Leaflets) Regulations, 1993, ( S.I. No. 71 of 1993 ) in order to give effect to Article 7 (2) of the Council Directive 92/73/EEC of 22nd September, 1992 (O.J. No. L297 of 13.10.92) widening the scope of Directives 65/66/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.