Medicines (Labelling) Amendment Regulations 1977
| Jurisdiction | UK Non-devolved |
| Citation | SI 1977/996 |
1977 No. 996
MEDICINES
The Medicines (Labelling) Amendment Regulations 19772ndJune 1977
10thJune 1977
1stJuly 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 85(1), 85(4) 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 and interpretation
1. These regulations, which may be cited as the Medicines (Labelling) Amendment Regulations 1977, shall be read as one with the Medicines (Labelling) Regulations 1976(c) (hereinafter referred to as "the principal regulations").
Commencement
2. These regulations shall come into operation on 1st July 1977 and in the case of regulations 9 and 10 shall, subject to the provisions of regulation 19 of the principal regulations (temporary provisions), have effect—
(a) in relation to a dispensed medicinal product, on 1st July 1977 in the case of regulation 9 and on 1st July 1979 in the case of regulation 10;
(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 section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c.28).
(c) S.I. 1976/1726 (1976 III, p. 4570).
(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 1st July 1977, or
(ii) a product licence which has been granted before 1st July 1977 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 1st July 1977, except where the provisions of the product licence, as so varied, include a provision 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 paragraphs (a), (b), (d) or (e) of this regulation apply, on 1st January 1978;
(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 the principal 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 July 1979, or
(ii) where such medicinal product is not such a product as is mentioned in the preceding sub-paragraph, on 1st July 1980;
(e) in relation to such a medicinal product as is mentioned in regulation 14 of the principal regulations (medicinal products for incorporation in animal feeding stuffs), on 1st January 1978,
and, in the case of paragraph (2) of regulation 13 and paragraph (1) of regulation 14 shall, subject to the provisions of regulation 19 of the principal regulations, have effect—
(f) in relation to a medicinal product which is assembled in the same labelled container in which the product is to be sold or supplied in circumstances corresponding to retail sale, on 1st July 1979, or
(g) in relation to a medicinal product which is not such a product as is mentioned in sub-paragraph (f) above, on 1st July 1980.
Amendment of regulation 2 of the principal regulations
3.—(1) Regulation 2 of the principal regulations (commencement) shall be amended in accordance with the following paragraphs of this regulation.
(2) In paragraph (c), for the words "1st July 1977" there shall be substituted the words "1st January 1978".
(3) In paragraph (d), for the words "1st January 1979" there shall be substituted the words "1st July 1979" and for the words "1st January 1980" there shall be substituted the words "1st July 1980".
(4) In paragraph (e), for the words "1st July 1977" there shall be substituted the words "1st January 1978".
Amendment of regulation 3 of the principal regulations
4. In regulation 3(1) of the principal regulations (definitions)—
(a) immediately after the definition of "appropriate non-proprietary name", for the words "appropriate quantitive particulars" there shall be substituted the words "appropriate quantitative particulars" and in paragraph (iv) of the said definition of "appropriate quantitative particulars" the word "active" shall be omitted in the second place where it occurs;
(b) for the definition of "expiry date" there shall be substituted the definition—
" "expiry date" means the date after which, or the month and year after the end of which, the medicinal product should not be used, or the date before which, or the month and year before the beginning of which, the medicinal product should be used;";
(c) immediately after the definition of "medicinal product" there shall be inserted the definition—
" "medicinal product on a general sale list" has the same meaning as in section 51(2) of the Act;";
(d) in the definition of "unit preparation", for the words "inert liquid diluent" there shall be substituted the words "inert diluent" and for the words "in liquid form or" there shall be substituted the words "in this diluted form or, where applicable,".
Amendment of regulation 9 of the principal regulations
5.—(1) Regulation 9 of the principal regulations (dispensed medicinal products) shall be amended in accordance with the following paragraphs of this regulation.
(2) After paragraph (2) there shall be inserted the following two paragraphs:—
"(3) Where a number of containers or packages, or of containers and packages, of dispensed medicinal products all of the same description are enclosed in a package, paragraph (1)(f) of this regulation shall be deemed to have been complied with if such of the particulars referred to in that paragraph as would, apart from this paragraph, be required to be shown on each container or package, or on each container and package so enclosed are shown either on one or more of such containers or packages or on the package which immediately encloses such containers or packages or such containers and packages as the case may be.
(4) Where a medicinal product is a dispensed medicinal product by reason only of its being a medicinal product falling within the definitions in sub-paragraphs (iv) or (v) of the definition of "dispensed medicinal product" in paragraph (1) of regulation 3 of these regulations, the container or package of such product shall not be required to be labelled in accordance with the provisions of this regulation if and so long as such container or package is labelled in accordance with the provisions of...
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