1994 No. 104
The Medicines (Labelling and Leaflets) Amendment Regulations 1994
Made
Laid before Parliament
Coming into force
The Secretaries of State respectively concerned with health in England, in Wales and in Scotland and the Department of Health and Social Services for Northern Ireland, acting jointly, in exercise of powers conferred upon them by sections 85(1), 86(1) and 91(3) of the Medicines Act 19681 or, as the case may be, those conferred by the said provisions and now vested in them2, and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations3, hereby make the following Regulations:
Citation, commencement and interpretation1
1
These Regulations may be cited as the Medicines (Labelling and Leaflets) Amendment Regulations 1994, and shall come into force on 14th February 1994.
Amendment of regulation 3(1) of the Labelling Regulations2
In regulation 3(1) of the Labelling Regulations (interpretation)—
a
after the definition of “homoepathic product”, there shall be inserted the following definition—
“homoeopathic product to which Council Directive 92/73/EEC6 applies” means a medicinal product for human use (which may contain a number of principles) prepared from products, substances or compositions called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a member State, other than one—
i
prepared in accordance with a magistral or officinal formula as defined in Article 1(4) and (5) of the 1965 Directive, or
ii
which satisfies the criteria laid down in Article 2(4) of the 1965 Directive;
b
in the definition of “product to which Chapters II to V of the 1965 Directive apply”7 for “and Article 1 of Council Directive 89/381/EEC(e)” there shall be substituted “, Article 1 of Council Directive 89/381/EEC(e) and Article 9(1) of Council Directive 92/73/EEC”.
Insertion of regulation 4F into the Labelling Regulations3
After regulation 4E of the Labelling Regulations, there shall be inserted the following regulation—
Standard labelling requirements for containers and packages of certain homoeopathic products4F
1
Containers and packages of homoeopathic products to which Council Directive 92/73/EEC applies shall be labelled in clear and legible form to show a reference to their homoeopathic nature, in particular by clear mention of the words “homoeopathic medicinal product”, in addition to any particulars required by any other provision of these regulations.
2
Where products referred to in paragraph (1) above are placed on the market in accordance with a certificate granted under the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 19948, containers and packages of such products shall be labelled to show the particulars set out in Schedule 9 to these regulations and no other particulars.
3
Regulations 5, 11, 14A to E, 15 and 16 of these regulations shall not apply in relation to products referred to in paragraph (2) above.
Insertion of Schedule 9 into the Labelling Regulations4
After Schedule 8 to the Labelling Regulations, there shall be inserted the following Schedule—
SCHEDULE 9STANDARD LABELLING REQUIREMENTS FOR CONTAINERS ANDPACKAGES OF HOMOEOPATHIC PRODUCTS MARKETED UNDER ACERTIFICATE GRANTED UNDER THE MEDICINES (HOMOEOPATHICMEDICINAL PRODUCTS FOR HUMAN USE) REGULATIONS 1993
1
The scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in relation to the homoeopathic manufacturing procedure described therein for that stock or stocks.
2
The name and address of the holder of the certificate of registration and, where different, the name and address of the manufacturer.
3
The method of administration and, if necessary, route.
4
The expiry date of the product in clear terms, stating the month and year.
5
The pharmaceutical form.
6
The contents of the sales presentation.
7
Any special storage precautions.
8
Any special warning necessary for the product concerned.
9
The manufacturer’s batch number.
10
The registration number allocated by the licensing authority preceded by the letters “HR” in capital letters.
11
The words “homoeopathic medicinal product without approved therapeutic indications”.
12
A warning advising the user to consult a doctor if the symptoms persist during the use of the product.
Amendment of regulation 2(1) of the Leaflets Regulations5
1
Regulation 2(1) of the Leaflets Regulations (interpretation) shall be amended in accordance with the following paragraphs of this regulation.
2
After the definition of “the Act”there shall be inserted the following definition—
“certificate of registration” means a certificate granted under the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994;
3
After the definition of “generator” there shall be inserted the following definitions—
“homoeopathic medicinal product” means a medicinal product (which may contain a number of principles) prepared from products, substances or compositions called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a member State;
“homoeopathic product to which Council Directive 92/73/EEC10 applies” means a homoeopathic medicinal product for human use other than one—
- i
prepared in accordance with a magistral or officinal formula as defined in Article 1(4) and (5) of the 1965 Directive, or
- ii
which satisfies the criteria laid down in Article 2(4) of the 1965 Directive;
4
In the definition of “product to which Chapters II to V of the 1965 Directive apply”11 for “and Article 1 of Council Directive 89/381/EEC(e)” there shall be substituted “, Article 1 of Council Directive 89/381/EEC(e) and Article 9(1) of Council Directive 92/73/EEC”.
5
In the definition of “proprietary medicinal product”, for “but does not include a homoeopathic medicinal product or” there shall be substituted “including a homoeopathic product to which Council Directive 92/73/EEC applies, but does not include a”.
Amendment of regulation 3 of the Leaflets Regulations6
In paragraph (1) of regulation 3 of the Leaflets Regulations (standard requirements relating to leaflets), after “relevant medicinal products” there shall be inserted “or homoeopathic products to which Council Directive 92/73/EEC applies”.
Insertion of regulation 3B into the Leaflets Regulations7
After regulation 3A of the Leaflets Regulations, there shall be inserted the following regulation—
Standard requirements relating to leaflets for homoeopathic products 3B
Subject to the following provisions of these regulations, any leaflet which is enclosed in or supplied with the packaging of a proprietary medicinal product which is a homoeopathic product to which Council Directive 92/73/EEC applies and which is placed on the market in the United Kingdom in accordance with a certificate of registration, shall, in addition to clear mention of the words “homoeopathic medicinal product”, contain the particulars set out in Schedule 3 to these regulations and no other particulars.
Amendment of regulation 4 of the Leaflets Regulations8
In paragraph (1) of regulation 4 of the Leaflets Regulations (general provisions) after the words “Part II of the Act” there shall be inserted “or any certificate of registration”.
Amendment of regulation 5 of the Leaflets Regulations9
In regulation 5 of the Leaflets Regulations (approval of contents of leaflets)—
a
in paragraph (1), after “product licence” there shall be inserted “or of a certificate of registration”;
b
in paragraph (2), after the words “product licence” there shall be inserted “or of a certificate of registration” and after “holder of the licence” there shall be inserted “or certificate”.
Insertion of Schedule 3 into the Leaflets Regulations10
After Schedule 2 to the Leaflets Regulations, there shall be inserted the following Schedule—
SCHEDULE 3PARTICULARS REQUIRED TO BE INCLUDED IN LEAFLETS RELATING TO HOMOEOPATHIC PRODUCTS MARKETED UNDER A CERTIFICATE OF REGISTRATION
1
The scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in relation to the homoeopathic manufacturing procedure described therein for that stock or stocks.
2
The name and address of the holder of the certificate of registration and, where different, the name and address of the manufacturer.
3
The method of administration and, if necessary, route.
4
The expiry date of the product in clear terms, stating the month and year.
5
The pharmaceutical form.
6
The contents of the sales presentation.
7
Any special storage precautions.
8
Any special warning necessary for the product concerned.
9
The manufacturer’s batch number.
10
The registration number allocated by the licensing authority preceded by the letters “HR” in capital letters.
11
The words “homoeopathic medicinal product without approved therapeutic indications”.
12
A warning advising the user to consult a doctor if the symptoms persist during the use of the product.
Signed by authority of the Secretary of State for Health
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on 17th December 1993.
(This note is not part of the Regulations)