SCHEDULES

SCHEDULE 1U.K.Further provisions for classification of medicinal products

PART 1U.K.Descriptions of certain medicinal products to be available only on prescription

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; F8...]

[F9(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 [F10; and]]

[F11(i)an EAMS medicinal product, in circumstances where the licensing authority has attached a condition to the EAMS scientific opinion in respect of that product to the effect that, for the duration of that opinion, 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

Marginal Citations