The Prescription Only Medicines (Human Use) Order 1997

Circumstances in which controlled drugs and medicinal products authorized by the European Community are not prescription only medicines

6.—(1) A medicinal product shall not be a prescription only medicine by reason that it is a controlled drug listed in Schedule 2 to the Misuse of Drugs Act 1971 where, it–

(a) contains not more than one of the substances listed in column 1 of Schedule 2 to this Order and no other controlled drug;

(b) contains that substance at a strength that does not exceed the maximum strength specified in column 2 of that Schedule; and

(c) is sold or supplied–

(i) in such pharmaceutical form as may be specified in column 3 of that Schedule, and

(ii) for use at a maximum dose which does not exceed that specified in column 4 of that Schedule.

(2) A medicinal product for human use in respect of which a marketing authorization has been granted under Council Regulation 2309/93/EEC(1) shall not be a prescription only medicine where that authorization does not classify the medicinal product as subject to medical prescription.

(1)

OJ No. L214, 24.8.93, p. 1.