The Human Medicines Regulations 2012

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1.  The following medicinal products shall be available only on prescription—U.K.

(a)a product for parenteral administration;

(b)a product that is a controlled drug [F1as defined in section 2(1)(a) of the Misuse of Drugs Act 1971], unless it is covered by a [F2UK] marketing authorisation in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale;

(c)cyanogenic substances, other than preparations for external use;

(d)medicinal substances that on administration emit radiation, or contain or generate any substance which emits radiation, in order that radiation may be used;

(e)a product that—

(i)is covered by a [F3UK marketing authorisation, EU marketing authorisation, Article 126a authorisation or parallel import licence] in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale, and

(ii)consists of or contains aloxiprin, aspirin or paracetamol in the form of non-effervescent tablets or capsules;

(f)a product that—

(i)is covered by a [F4UK marketing authorisation, EU marketing authorisation, Article 126a authorisation or parallel import licence] in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale, and

(ii)consists of or contains (in any pharmaceutical form) pseudoephedrine salts or ephedrine base or salts; F5...

(g)a product that—

(i)is not covered by a [F6UK marketing authorisation, EU marketing authorisation, Article 126a authorisation or parallel import licence], and

(ii)is a prescription only medicine by virtue of articles 5 and 10 of, and Schedules 1 and 2 to, the Prescription Only Medicines (Human Use) Order 1997 M1 [F7; and]

[F8(h)a product which is authorised by the licensing authority on a temporary basis under regulation 174, in circumstances where the licensing authority has attached a condition to that authorisation to the effect that, for the duration of the temporary authorisation, the product is classified as a prescription only medicine.]

Textual Amendments

F1Words in Sch. 1 para. 1(b) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 10 and words in Sch. 1 para. 1(b) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 10

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