(1)    This Order may be cited as the Medicines (Products Other than Veterinary Drugs) (General Sale List) Amendment Order 2002 and shall come into force on 1st April 2002.

(2)    In this Order, “the principal Order” means the Medicines (Products Other than Veterinary Drugs) (General Sale List) Order 1984.

The principal Order is amended as follows—

(a)    in paragraph (2)(a) of article 1 (interpretation), after the definition of “irrigation” there shall be inserted the following definition—

““marketing authorization” means a marketing authorization granted by—

(a)    the European Commission in accordance with Council Regulation (EEC) No 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products; or

(b)    the licensing authority under the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994;”; and

(b)    for article 2 (which specifies classes of medicines on a general sale list), there is substituted the following article—

There are hereby specified classes of medicinal products which in the opinion of the Ministers can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist, namely, medicinal products which are not prescription only medicines but which are—

(a)    medicinal products in respect of which a marketing authorization has been granted, which in the marketing authorization are classified as being general sale list medicines;

(b)    medicinal products in respect of which no marketing authorization has been granted, other than products the subject of a product licence of right, which fall within the class specified in Schedule 1 but which do not fall within a class specified in Schedule 3;

(c)    medicinal products which are products the subject of a product licence of right and which fall within the class specified in Schedule 2 but which do not fall within a class specified in Schedule 3; and

(d)    medicinal products which are for sale or supply either for oral administration as a food or for external use as a cosmetic, other than products which are eye drops or eye ointments or which contain either—

(i)    Vitamin A, Vitamin A acetate or Vitamin A palmitate with a maximum daily dose equivalent to more than 7500 international units of Vitamin A or 2250 micrograms of retinol, or

(ii)    Vitamin D with a maximum daily dose of more than 400 units of antirachitic activity.”.

Signed by authority of the Secretary of State for Health

Hunt

Parliamentary Under Secretary of State,

Department of Health

11th March 2002

Bairbre de Brún

Minister of Health,

Social Services and Public Safety

7th March 2002

This Order further amends the Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984 (“the principal Order”) which specifies classes of medicinal products which can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist (the general sale list).

Article 2 amends article 2 of the principal Order (which specifies classes of medicinal products on a general sale list) to provide that medicinal products which have been granted a marketing authorization will be available on general sale if so classified in their marketing authorization. Medicinal products for which no marketing authorization has been granted, or for which there is a product licence of right, will continue to be classified as general sale if they fall within the class specified in Schedule 1 or 2 and are not specified in Schedule 3.

A Regulatory Impact Assessment in relation to this Order has been placed in the libraries of both Houses of Parliament. Further copies may be obtained from the Department of Health, Medicines Control Agency, Information Centre, Room 10–202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.