Medicines (Labelling and Leaflets) Amendment Regulations 1994
| Jurisdiction | UK Non-devolved |
| Citation | SI 1994/104 |
| Year | 1994 |
1994No. 104
MEDICINES
The Medicines (Labelling and Leaflets) Amendment
Regulations 1994
19thJanuary1994
24thJanuary1994
14thFebruary1994
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 1968 ( a)or, as the case may be, those conferred by the said provisions and now vested in them ( b), 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 Regulations ( c), hereby make the following Regulations:
Citation, commencement and interpretation
1.-(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 ( d) and "the Leaflets Regulations" means the Medicines (Leaflets) Regulations 1977 ( e).
Amendment of regulation 3(1) of the Labelling Regulations
2. 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 ( f) 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(a) 1968 c.67. The expression "the appropriate Ministers" is defined in section 1(1)(a) and (2) of that Act as amended by S.I. 1969/388, Schedule 1.
(b) In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388); in the case of the Department of Health and Social Services for Northern Ireland by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c.36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c.28).
(c) See section 129(6) of the Medicines Act 1968.
(d) S.I. 1976/1726; relevant amending instruments are S.I. 1977/996 and 2168, 1978/41 and 1140, 1983/1729, 1985/1558, 1988/1009, 1992/3273.
(e) S.I. 1977/1055; the relevant amending instrument is S.I. 1992/3274.
(f) OJ No. L297, 13.10.92, p. 8.
(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" ( g) 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 Regulations
3. 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 ( h), 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 Regulations
4. After Schedule 8 to the Labelling Regulations, there shall be inserted the following Schedule-
"SCHEDULE 9 |
Regulation 4F(2) |
STANDARD LABELLING REQUIREMENTS FOR CONTAINERS ANDPACKAGES OF HOMOEOPATHIC PRODUCTS MARKETED UNDER ACERTIFICATE GRANTED UNDER THE MEDICINES...
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