The Human Medicines Regulations 2012

Regulation 5

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

PART 1 U.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 [F1 as defined in section 2(1)(a) of the Misuse of Drugs Act 1971], unless it is covered by a 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 marketing authorisation 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 marketing authorisation 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; and

(g) a product that—

(i) is not covered by a marketing authorisation, 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 .

Textual Amendments

F1 Words 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

M1 S.I. 1997/1830, as amended by S.I. 1997/2044, S.I. 1998/108, S.I. 1998/1178, S.I. 1998/2081, S.I. 1999/1044, S.I. 1999/3463, S.I. 2000/1917, S.I. 2000/2899, S.I. 2000/3231, S.I. 2001/2777, S.I. 2001/3942, S.I. 2003/696 and S.I. 2006/915 and these Regulations. There are other amendments, but none is relevant.

2.  In this Part “ cyanogenic substances” means preparations which— U.K.

(a) are presented for sale or supply under the name of, or as containing, amygdalin, laetrile or vitamin B17; or

(b) contain more than 0.1 per cent by weight of any substance having the formula either—

(i) alpha-Cyanobenzyl -6-O-Beta-d-glucopyranosyl -Beta-d-glucopyranoside, or

(ii) alpha-Cyanobenzyl -Beta-d-glucopyranosiduronic acid.

PART 2 U.K. Descriptions of certain medicinal products to be available only from a pharmacy

3.  The following medicinal products shall be available only from a pharmacy— U.K.

(a) a product comprising eye ointment;

(b) a product that contains Vitamin A, Vitamin A acetate or Vitamin A palmitate, in each case with a maximum daily dose equivalent to more than 7500 international units of Vitamin A or 2250 micrograms of retinol;

(c) a product that contains Vitamin D with a maximum daily dose of more than 400 units of antirachitic activity.

4.  The following medicinal products shall be available only from a pharmacy unless they are the subject of a marketing authorisation or traditional herbal registration that classifies them as medicinal products subject to general sale— U.K.

(a) a product that is for use as an anthelmintic;

(b) a product that is for parenteral administration;

(c) a product that is for use as an enema;

(d) a product that is for use wholly or mainly for irrigation of—

(i) wounds, or

(ii) the bladder, vagina or rectum;

(e) a product that is for administration wholly or mainly to children being a preparation of aloxiprin or aspirin.

5.  A medicinal product shall be available only from a pharmacy if it is a medicinal product of a kind specified in Schedule 15 but is not presented for sale in accordance with the requirements specified in that Schedule for a product of that kind to be subject to general sale. U.K.