The Medicines (Products Other Than Veterinary Drugs) (General Sale List) Amendment Order 2002

Amendments of the principal Order

2.  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(1); or

  (b)

  the licensing authority under the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(2);”; and

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

“General sale list

2.   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.”.

(1)

OJ No. L 214, 24.8.1993, p.1.

(2)

S.I. 1994/3144, amended by S.I. 1998/3105, 2000/292, 2001/795 and 2002/236.