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 [F1; F2...]
[F3(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 [F4; and]]
[F5(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
F1Word 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)
F2Word 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)
F3Sch. 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)
F4Word 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)
4. The following medicinal products shall be available only from a pharmacy unless they are the subject of a [F6UK marketing authorisation, EU marketing authorisation, 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
F6Words 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)
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.