Medicines (Labelling) Regulations 1976
| Jurisdiction | UK Non-devolved |
| Citation | SI 1976/1726 |
| Year | 1976 |
1976 No. 1726
MEDICINES
The Medicines (Labelling) Regulations 197614thOctober 1976
28thOctober 1976
22ndNovember 1976
The Secretaries of State respectively concerned with health in England and in Wales, the Secretary of State concerned with health and with agriculture in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred by sections 85(1), 85(4), 86(1), and 91(2) and (3) of the Medicines Act 1968(a) 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 the following regulations, hereby make the following regulations:—
Citation
1. These regulations may be cited as the Medicines (Labelling) Regulations 1976.
Commencement
2. These regulations shall come into operation on 22nd November 1976 and, subject to the provisions of regulation 19 of these regulations, shall have effect—
(a) in relation to a dispensed medicinal product, on 22nd November 1976;
(b) in relation to a medicinal product to which—
(i) a product licence, clinical trial certificate or animal test certificate relates which is granted or issued on or after 22nd November 1976, or
(ii) a product licence which has been granted before 22nd November 1976 relates, any of the provisions of which relating to the composition of the medicinal product, or particulars as to the uses and effect of, or warnings concerning, the product, are varied on or after 22nd November 1976, except where the provisions of the product licence, as so varied, include a provision
(a) 1968 c. 67.
(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 (1969 I, p. 1070)), and in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and paragraph 2(1)(b) of Schedule 1 to the Northern Ireland Act 1974 (c. 28).
that labelling on containers and packages of the product may continue to be used after the date on which the provisions of the licence are so varied,
on the date on which such licence or certificate is granted or issued or the provisions of such licence are varied, as the case may be;
(c) in relation to a medicinal product, not being a medicinal product to which the provisions of paragraph (a), (b), (d) or (e) of this regulation apply, on 1st July 1977;
(d) in relation to a medicinal product to which a product licence which is a licence of right relates, or a medicinal product in such a container as is mentioned in paragraph (3) or (4) of regulation 5 of these regulations (small containers, wrappers or sealed units), not, in either case, being a medicinal product to which the provisions of paragraph (a) or (b) of this regulation apply—
(i) where such medicinal product is assembled in the same labelled container in which the product is to be sold by retail or supplied in circumstances corresponding to retail sale, on 1st January 1979, or
(ii) where such medicinal product is not such a product as is mentioned in the preceding sub-paragraph, on 1st January 1980;
(e) in relation to such a medicinal product as is mentioned in regulation 14 of these regulations (medicinal products for incorporation in animal feeding stuffs), on 1st July 1977.
Interpretation
3.—(1) In these regulations, unless the context otherwise requires—
"the Act" means the Medicines Act 1968;
"animal feeding stuff" includes a complete feeding stuff, a feed supplement and a protein concentrate;
"appropriate non-proprietary name" in relation to a medicinal product or ingredient means—
(i) where the medicinal product or ingredient is described in a monograph in a specified publication any name, or abbreviation of such name, at the head of that monograph or, in the case of the European Pharmacopoeia, an approved synonym or, where such name consists of two or more words, any name derived from a suitable inversion of such words which is permitted by that specified publication, or
(ii) where the medicinal product or ingredient is not described in a monograph in a specified publication but has an approved name, such approved name, or
(iii) where the medicinal product or ingredient is not described in a monograph in a specified publication and does not have an approved name, but has an international non-proprietary name, such international non-proprietary name, or
(iv) where the medicinal product is not described in a monograph in a specified publication and does not have an approved name or an international non-proprietary name, the accepted scientific name or any other name descriptive of the true nature of the medicinal product or ingredient;
"appropriate quantitive particulars" means—
(i) the quantity of each active ingredient, or that part of the active molecule responsible for the therapeutic or pharmacological activity, identified by its appropriate non-proprietary name, in each dosage unit of the medicinal product expressed in terms of weight, volume, capacity, or units of activity, or, where the medicinal product consists of confectionery in the form of a pastille or lozenge, expressed as aforesaid or in terms of a percentage by weight or volume of such pastille or lozenge, or, where the medicinal product is a homoeopathic product, expressed in terms of the dilution of the unit preparation of that active ingredient, or
(ii) where there is no dosage unit, the quantity of each active ingredient or that part of the active molecule responsible for the therapeutic or pharmacological activity, identified by its appropriate non-proprietary name, in the container of the medicinal product expressed in terms of weight, volume, capacity, or units of activity, or percentage by weight or volume of the total quantity, or, where the medicinal product is a homoeopathic product, expressed in terms of the dilution of the unit preparation of that active ingredient, or
(iii) where the medicinal product contains any active ingredient that cannot be definitively characterised, the quantity of each ingredient or that part of the active molecule responsible for the therapeutic or pharmacological activity, identified by its appropriate non-proprietary name, expressed in terms of weight, volume, capacity, or units of activity or percentage by weight or volume, from which each dosage unit of the medicinal product, or, where there is no dosage unit, the quantity of the medicinal product in the container, has been prepared, or, where the medicinal product is a herbal remedy in solution in liquid form, the total quantity of the active ingredient which is in solid form in the container, or, where the medicinal product is a homoeopathic product, expressed in terms of the dilution of the unit preparation of that active ingredient or
(iv) where there are no active ingredients in the medicinal product, the quantity of the ingredient which is present in the highest proportion whether in weight, volume or capacity, identified by its appropriate non-proprietary name, expressed in terms of weight, volume, capacity, or percentage by weight or volume of the total quantity from which the medicinal product in the container has been prepared, except where such ingredient is a diluent, excipient, preservative, stabiliser or bulking agent or, where the medicinal product is a homoeopathic product, expressed in terms of the dilution of the unit preparation of that active ingredient, or
(v) where the medicinal product includes a biological substance to which an antimicrobial preservative has been added in addition to an active ingredient, the quantity of such antimicrobial preservative in the container of the medicinal product, expressed in terms of weight, volume, capacity or percentage by weight or volume of the total quantity;
"approved name" means the name which appears in the current edition (as defined in section 103(5) of the Act) of the list prepared and published under section 100 of the Act as in force at the time of sale or supply of the medicinal product by the person who has labelled the container of the medicinal product;
"approved synonym" has the same meaning as in section 65(8) of the Act;
"biological substance" includes an antigen, toxin, antitoxin, serum, antiserum or vaccine;
"business name" means a name or style under which any business is being carried on, being a name or style required to be registered under the Registration of Business Names Act 1916(a);
"complete feeding stuff" means a substance or a mixture of substances designed for feeding to animals without further mixing with other feeding stuffs;
"data sheet" has the same meaning as in section 96(6) of the Act;
"dispensed medicinal product" means—
(i) a medicinal product prepared or dispensed by a practitioner or prepared or dispensed in accordance with a prescription given by a practitioner, or
(ii) a medicinal product for use by being administered to human beings where that medicinal product has been sold or supplied by a doctor or dentist for administration to a particular patient of his and that doctor or dentist sells or supplies that medicinal product to that patient or to a person under whose care that patient is, or
(iii) a medicinal product for use by being administered to animals where that medicinal product has been sold or supplied by a veterinary surgeon or veterinary practitioner for administration to a particular animal or herd which is under the care of that veterinary surgeon or veterinary practitioner, to a person having the possession or control of that animal or herd, or
(iv) a medicinal product prepared or dispensed in a registered pharmacy by or under the supervision of a pharmacist...
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