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The Human Medicines Regulations 2012, PART 8 is up to date with all changes known to be in force on or before 31 August 2024. 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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156.—(1) The licensing authority may grant an Article 126a authorisation for [F1sale or supply of] a medicinal product [F2in Northern Ireland only,] if the following conditions are met.
(2) Condition A is that no United Kingdom marketing authorisation, certificate of registration or traditional herbal registration is in force [F3in Northern Ireland] for the product.
(3) Condition B is that no application is pending in the United Kingdom for a marketing authorisation, certificate of registration or traditional herbal registration [F4to be in force in Northern Ireland] for the product.
(4) Condition C is that the licensing authority considers that the placing of the product on the market in [F5Northern Ireland] is justified for public health reasons.
(5) Condition D is that the product is imported from [F6an EU member State] that has, in accordance with the 2001 Directive, authorised the placing on the market of the product in that member State.
(6) Condition E is that the person to whom the authorisation is granted is established in the European Union.
(7) Before granting an Article 126a authorisation, the licensing authority must notify the authorisation holder in the member State mentioned in paragraph (5) of the proposal to grant the Article 126a authorisation.
(8) Before granting an Article 126a authorisation, the licensing authority may request the competent authority in the member State mentioned in paragraph (5) to provide in accordance with Article 126a(3)(b) of the 2001 Directive a copy of—
(a)the assessment report for that product as mentioned in Article 21(4) of the 2001 Directive; and
(b)the authorisation in force for that product.
(9) An Article 126a authorisation remains in force for the period specified in it unless revoked before the end of that period.
(10) That period may be specified by reference to the occurrence or non-occurrence of a particular event or events.
Textual Amendments
F1Words in reg. 156(1) inserted (31.12.2020) by S.I. 2019/775, reg. 132(a)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
F2Words in reg. 156(1) inserted (31.12.2020) by S.I. 2019/775, reg. 132(a)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
F3Words in reg. 156(2) inserted (31.12.2020) by S.I. 2019/775, reg. 132(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
F4Words in reg. 156(3) inserted (31.12.2020) by S.I. 2019/775, reg. 132(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
F5Words in reg. 156(4) substituted (31.12.2020) by S.I. 2019/775, reg. 132(d) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
F6Words in reg. 156(5) substituted (31.12.2020) by S.I. 2019/775, reg. 132(e) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
157.—(1) Paragraph (2) applies where the licensing authority [F8, in relation to a UKMA(NI),] is requested by the competent authority of [F9a member State] to provide in accordance with Article 126a(3)(b) of the 2001 Directive a copy of—
(a)the assessment report for a medicinal product as mentioned in regulation 64(5) (duties of licensing authority in connection with determination); and
(b)the marketing authorisation in force for that product.
(2) The licensing authority must supply those documents to the competent authority before the end of the period of thirty days beginning on the day after the request is received.
Textual Amendments
F7Words in reg. 157 heading substituted (31.12.2020) by S.I. 2019/775, reg. 132A(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
F8Words in reg. 157(1) inserted (31.12.2020) by S.I. 2019/775, reg. 132A(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
F9Words in reg. 157(1) substituted (31.12.2020) by S.I. 2019/775, reg. 132A(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
158. The following provisions of Part 5 (marketing authorisations) apply to an Article 126a authorisation as they apply to a marketing authorisation—
(a)regulation 62 (classification of marketing authorisation);
(b)regulation 63 (frequency of periodic safety update reports);
(c)regulation 68 (revocation etc of marketing authorisation) and Schedule 11 (advice and representations in connection with revocations etc) so far as relating to that regulation;
(d)regulation 69 (suspension of use etc of medicinal product);
(e)regulation 71 (withdrawal of medicinal products from the market);
(f)regulation 72 (sale etc of suspended medicinal product);
(g)regulation 80 (urgent safety restrictions); and
(h)regulations 98 (general offence of breach of provision of this Part), 99 (penalties) and 101(1) and (2) (defences), so far as relating to the regulations mentioned in sub-paragraphs (a) and (e) to (f).
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