The Human Medicines Regulations 2012

PART 8 Article 126a authorisations

Article 126a authorisations

156.—(1) The licensing authority may grant an Article 126a authorisation for a medicinal product 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 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 for the product.

(4) Condition C is that the licensing authority considers that the placing of the product on the market in the United Kingdom is justified for public health reasons.

(5) Condition D is that the product is imported from another 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.

Requests from other member States

157.—(1) Paragraph (2) applies where the licensing authority is requested by the competent authority of another 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.

Application of these Regulations

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).