Medicines (Leaflets) Regulations 1977
| Jurisdiction | UK Non-devolved |
1977 No. 1055
MEDICINES
The Medicines (Leaflets) Regulations 1977
Made 21th June 1977
Laid before Parliament 24th June 1977
Coming into Operation 15th July 1977
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 86(1) and 91(2) of the Medicines Act 1968 and now vested in them1and 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 regulations, hereby make the following regulations:—
Citation and commencement
1. These regulations may be cited as the Medicines (Leaflets) Regulations 1977 and shall come into operation on 15th July 1977.
Interpretation
2.—(1) In these regulations, unless the context otherwise requires—
“” means
“”
“” means—
(a) a ready-prepared medicinal product placed on the market in the United Kingdom under a special name and in a special pack,
(b) for the purposes of paragraph (a) “” does not include—
(i) vaccines, toxins or serums,
(ii) medicinal products based on human blood or blood constituents or radioactive isotopes,
(iii) homoeopathic medicinal products, or
(iv) veterinary drugs;
and other expressions have the same meanings as in the Act or in the Medicines (Labelling) Regulations 19762 as amended3
(2) Except in so far as the context otherwise requires, any reference in these regulations to any enactment, order or regulations shall be construed as a reference to that enactment or order or those regulations, as the case may be, as amended, extended or re-enacted by any other enactment, order or regulations.
(3) The rules for the construction of Acts of Parliament contained in the Interpretation Act 1889 shall apply for the purposes of the interpretation of these regulations as they apply for the purposes of the interpretation of an Act of Parliament.
Standard requirements relating to leaflets
3. Subject to the following provisions of these regulations, all leaflets relating to proprietary medicinal products which are supplied, or are intended to be supplied, with proprietary medicinal products shall contain the particulars set out in the Schedule to these regulations.
General provisions
4.—(1) All particulars contained in such a leaflet as is described in regulation 3 above, including the particulars required to be so contained by these regulations, shall be consistent with the provisions of any product licence granted under Part II of the Act in respect of the proprietary medicinal product which relates to such particulars.
(2) All particulars required by these regulations to be contained in such a leaflet shall, except with respect to numerals, be given in the English language.
(3) Except as provided in paragraph (4) below no such leaflet shall contain any reference to a medicinal product of any description other than the proprietary medicinal product with which that leaflet is supplied or is intended to be supplied.
(4) Notwithstanding the provisions of paragraph (3) above such a leaflet which—
(a)
(a) contains instructions solely in respect of the use of an apparatus or appliance for the purpose of administration of the proprietary medicinal product to which the leaflet relates, being instructions that are capable of having equal application to other medicinal products having the same pharmaceutical form, or
(b)
(b) contains the particulars set out in paragraphs 4 to 8 of the Schedule to these regulations, being particulars that would be the same in all respects in relation to other medicinal products of a different description, or
(c)
(c) contains any reference to a medicinal product other than the proprietary medicinal product to which the leaflet relates in so far as such reference is necessary to explain the contra-indications or precautions or the action to be taken in the event of overdosage of the proprietary medicinal product to which that leaflet relates,
may contain references to such other medicinal products.
(5) The particulars required by these regulations to be contained in such a leaflet shall be clearly separate from the remainder of the contents of the leaflet.
(6) The particulars set out in paragraphs 4 and 5 of the Schedule to these regulations shall not be required to be included in such a leaflet where—
(...
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