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The Human Medicines Regulations 2012, Section 203 is up to date with all changes known to be in force on or before 13 February 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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203.—(1) The licensing authority must set up and maintain a national medicines web-portal (“the UK web-portal”) F1...
(2) The licensing authority must make available publicly by means of the UK web-portal the following (at a minimum)—
(a)the assessment reports prepared or revised by the licensing authority under regulation 64(5) and (6) (duties of licensing authority in connection with determination), each with a summary;
(b)the summary of the product characteristics for the medicinal products concerned;
(c)the package leaflet for the medicinal products concerned;
(d)a summary of the risk management plan (if any) for the medicinal products concerned;
[F2(da)the list published by the licensing authority under, or which applies by virtue of, regulation 202A;]
(e)the list of medicinal products that are subject to additional monitoring referred to in Article 23 of Regulation (EC) No 726/2004; and
(f)information on the different ways of reporting suspected adverse reactions to medicinal products to the licensing authority by patients or their carers, health care professionals, coroners or procurators fiscal (including by way of the web-based structured forms referred to in Article 25 of Regulation (EC) No 726/2004).
Textual Amendments
F1Words in reg. 203(1) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 164(2); 2020 c. 1, Sch. 5 para. 1(1)
F2Reg. 203(2)(da) inserted (31.12.2020) by S.I. 2019/775, reg. 164(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 131)
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