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 [F2 UK] 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 [F3 UK marketing authorisation F4 ..., 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 [F5 UK marketing authorisation F6 ..., 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; F7 ...

(g) a product that—

(i) is not covered by a [F8 UK marketing authorisation F9 ..., 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 [F10 ; F11 ...]

[F12 (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 [F13 ; and]]

[F14 (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

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

F2 Word in Sch. 1 para. 1(b) inserted (31.12.2020) by S.I. 2019/775, reg. 8(a)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 5)

F3 Words in Sch. 1 para. 1(e)(i) substituted (31.12.2020) by S.I. 2019/775, reg. 8(a)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 5)

F4 Words in Sch. 1 para. 1(e)(i) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 134(a)(i)

F5 Words in Sch. 1 para. 1(f)(i) substituted (31.12.2020) by S.I. 2019/775, reg. 8(a)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 5)

F6 Words in Sch. 1 para. 1(f)(i) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 134(a)(ii)

F7 Word in Sch. 1 para. 1(f) omitted (6.11.2020) by virtue of The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 31(2)(a) and word in Sch. 1 para. 1(f) omitted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 31(2)(a)

F8 Words in Sch. 1 para. 1(g)(i) substituted (31.12.2020) by S.I. 2019/775, reg. 8(a)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 5)

F9 Words in Sch. 1 para. 1(g)(i) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 134(a)(iii)

F10 Word in Sch. 1 para. 1(g) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 31(2)(b) and word in Sch. 1 para. 1(g) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 31(2)(b)

F11 Word in Sch. 1 para. 1(g) omitted (15.4.2022) by virtue of The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(2)(a) (with reg. 19)

F12 Sch. 1 para. 1(h) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 31(2)(c) and Sch. 1 para. 1(h) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 31(2)(c)

F13 Word in Sch. 1 para. 1(h) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(2)(b) (with reg. 19)

F14 Sch. 1 para. 1(i) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(2)(c) (with reg. 19)

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 [F15 ; F16 ...]

[F17 (d) 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, it is only to be available from a pharmacy [F18 ; and]]

[F19 (e) 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, it is only to be available from a pharmacy.]

Textual Amendments

F15 Word in Sch. 1 para. 3(c) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 31(3)(a) and word in Sch. 1 para. 3(c) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 31(3)(a)

F16 Word in Sch. 1 para. 3(c) omitted (15.4.2022) by virtue of The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(3)(a) (with reg. 19)

F17 Sch. 1 para. 3(d) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 31(3)(b) and Sch. 1 para. 3(d) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 31(3)(b)

F18 Word in Sch. 1 para. 3(d) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(3)(b) (with reg. 19)

F19 Sch. 1 para. 3(e) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(3)(c) (with reg. 19)

4.  The following medicinal products shall be available only from a pharmacy unless they are the subject of a [F20 UK marketing authorisation F21 ..., Article 126a authorisation, parallel import licence] 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.

Textual Amendments

F20 Words in Sch. 1 para. 4 substituted (31.12.2020) by S.I. 2019/775, reg. 8(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 5)

F21 Words in Sch. 1 para. 4 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 134(b)

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.