The Medicines (Labelling and Leaflets) Amendment Regulations 1994

• Citation: S.I. 1994/104
• Sections: 10

Section 1 Citation, commencement and interpretation

(1) These Regulations may be cited as the Medicines (Labelling and Leaflets) Amendment Regulations 1994, and shall come into force on 14th February 1994.

(2) In these Regulations, “the Labelling Regulations ” means the Medicines (Labelling) Regulations 1976 and “the Leaflets Regulations ”means the Medicines (Leaflets) Regulations 1977 .

Section 2 Amendment of regulation 3(1) of the Labelling Regulations

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/ EEC 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” 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 ”.

Section 3 Insertion of regulation 4F into the Labelling Regulations

After regulation 4E of the Labelling Regulations, there shall be inserted the following regulation—

Standard labelling requirements for containers and packages of certain homoeopathic products

(4F)

(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 1994 , 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.

Section 4 Insertion of Schedule 9 into the Labelling Regulations

After Schedule 8 to the Labelling Regulations, there shall be inserted the following Schedule—

STANDARD 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.

Section 5 Amendment of regulation 2(1) of the Leaflets Regulations

(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/EEC applies” means a homoeopathic medicinal product for human use other than one—

prepared in accordance with a magistral or officinal formula as defined in Article 1(4) and (5) of the 1965 Directive, or

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” 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”.

Section 6 Amendment of regulation 3 of the Leaflets Regulations

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”.

Section 7 Insertion of regulation 3B into the Leaflets Regulations

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.

Section 8 Amendment of regulation 4 of the Leaflets Regulations

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”.

Section 9 Amendment of regulation 5 of the Leaflets Regulations

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”.

Section 10 Insertion of Schedule 3 into the Leaflets Regulations

After Schedule 2 to the Leaflets Regulations, there shall be inserted the following Schedule—

PARTICULARS 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.