Paragraph 1

United Kingdom

The following medicinal products shall be available only on prescription—

(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 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 F5UK 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 F8UK 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 M1F10; 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.

Annotations

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.