Citation, commencement and interpretation

1.—(1) These regulations may be cited as the Medicines (Fluted Bottles) Regulations 1978 and shall come into operation on 1st February 1978.

(2) In these regulations—

“the Act” means the Medicines Act 1968;

“external use” means—

and other expressions have the same meanings as in the Act.

(3) Except in so far as the context otherwise requires, any reference in these regulations to any provision of any enactment or instrument shall be construed as a reference to that provision as amended or extended by any enactment or instrument and as including a reference to any provision which may re-enact or replace it.

(4) 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 an Act of Parliament.

Requirements for containers of certain medicinal products

2.  Subject to the provisions of these regulations, and for the purposes of promoting safety in relation to medicinal products and securing that medicinal products are readily identifiable, the sale or supply of liquid medicinal products for external use containing or consisting of any substance set out in the Schedule to these regulations shall be prohibited unless such products are contained in a bottle the outer surface of which is fluted vertically with ribs or grooves recognisable by touch.

Exceptions

3.  The prohibition imposed by regulation 2 above shall not apply in the following circumstances—

(a)where medicinal products are contained in bottles with a capacity greater than 1.14 litres;

(b)where a medicinal product is sold or supplied and an exception is specified in column 2 of the Schedule to these regulations in relation to a medicinal product containing or consisting of a substance specified in column 1 of such Schedule;

(c)where a substance specified in column 1 of the Schedule to these regulations is contained in a medicinal product which is of a description or falling within a class specified in any order made under section 58(1) of the Act (medicinal products on prescription only), unless sold or supplied by retail sale or in accordance with a prescription given by a practitioner;

(d)where medicinal products for use solely outside the United Kingdom are placed in containers for the purpose of export;

(e)where medicinal products are sold or supplied solely for the purpose of scientific education, research or analysis;

(f)where eye or ear drops are sold or supplied in a plastic container; or

(g)where a product licence, clinical trial certificate or animal test certificate, or any variation of any such licence or certificate, enables medicinal products to be contained in a bottle otherwise than in accordance with the requirements set out in regulation 2 above.

Offences

4.  Any person who contravenes these regulations or who contravenes the provisions of section 87(2) of the Act shall be guilty of an offence and—

(a)shall be liable on summary conviction to a fine not exceeding £400, and

(b)shall be liable on conviction on indictment to a fine or to imprisonment for a term not exceeding two years or to both.

Regulations 2 and 3

SCHEDULE

EXPLANATORY NOTE

These Regulations made under the Medicines Act 1968 impose a prohibition upon the sale or supply of certain medicinal products for external use except in bottles which are recognisable by touch. The Regulations, which contain exceptions and criminal offences, are made for the purpose of promoting safety in, and ready identification of, medicinal products. They supersede Rule 26 of the Poisons Rules.