The Medicines (Labelling) Amendment (No. 2) Regulations 1977

• Citation: S.I. 1977/2168
• Sections: 3

Section 1 Citation and interpretation

These regulations, which may be cited as the Medicines (Labelling) Amendment (No. 2) Regulations 1977, shall be read as one with the Medicines (Labelling) Regulations 1976 as amended (hereinafter referred to as “ the principal regulations ”) and shall come into operation on 1st February 1978.

Section 2 Amendment of regulation 14D of the principal regulations

Regulation 14D of the principal regulations shall be amended as follows—

(1) The existing paragraph shall be numbered paragraph “(1)” ;

(2) The following paragraphs shall be inserted after paragraph (1)—

(2) Subject to the following provisions of these regulations, where a medicinal product (not being a dispensed medicinal product) which is a veterinary drug specified in Schedules 1, 2 or 3 to the Medicines (Exemptions from Restrictions on the Retail Sale or Supply of Veterinary Drugs) Order 1977 is sold by retail or supplied in circumstances corresponding to retail sale or is offered or exposed for sale by retail, every container and every package immediately enclosing a container of such product—

(a) shall be labelled to show—

(i) where the veterinary drug is one which is specified in Schedule 1 or 2 to the above order, the letters “PML”;

(ii) where the veterinary drug is one which is specified in Schedule 3 to the above order, the letters “ POM ”;

such letters to be in capitals within a rectangle within which there shall be no other matter of any kind,

(b) shall, where the veterinary drug is described in paragraph 6 or 7 of Schedule 6 to these regulations, be labelled to show the words and particulars set out in such paragraph or paragraphs as the case may be,

(c) shall be labelled in accordance with the provisions of regulation 14A of these regulations as if such provisions applied to such containers and packages as they apply to containers and packages of medicinal products on a general sale list.

(3) The requirements of paragraph (2)(a) above shall apply to every package immediately enclosing a container of a veterinary drug which is sold by way of wholesale dealing and which is not on a general sale list.

(4) Where a container or package is required by this regulation to be labelled to show any of the words or particulars contained in paragraph 6 or 7 of the said Schedule 6, such words or particulars shall be within a rectangle within which there shall be no other matter of any kind, except that where words or particulars set out in both of those paragraphs appear on the container or package then they may together be within a rectangle within which there shall be no other matter of any kind.

Section 3 Amendment of Regulation 14E of the principal regulations

Regulation 14E(1) of the principal regulations shall be amended by the addition of the words “or 14D(2)” after the words “provisions of regulations 14A to 14C” .