The Human Medicines Regulations 2012

Responding to a single assessment of PSUR under Article 107e of the 2001 DirectiveU.K.

This section has no associated Explanatory Memorandum

194.—(1) This regulation applies where PSURs relating to a medicinal product [F1authorised under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation] have been assessed under the EU single assessment procedure.

(2) The licensing authority must implement—

(a)the necessary measures that are consequent upon any agreement reached under Article 107g(2) of the 2001 Directive as part of the EU single assessment process, in accordance with the implementation timetable determined in the agreement; or

(b)any decision adopted under Article 107g(4)(a) of the 2001 Directive before the end of the period of 30 days beginning on the day after the day on which the licensing authority received notification of the decision.

(3) Paragraph (4) applies where—

(a)an agreement reached under Article 107g(2) of the 2001 Directive requires a variation to be made to an authorisation or registration; and

(b)the terms of the agreement are known to the holder of that authorisation or registration.

(4) A holder of an authorisation or registration referred to in paragraph (3)(a) must submit to the licensing authority in accordance with the implementation timetable determined in the agreement an appropriate application for a variation, including—

(a)an updated summary of the product characteristics; and

(b)an updated package leaflet.

(5) In this regulation, “EU single assessment procedure” means the single assessment procedure laid down in Article 107e of the 2001 Directive, which covers—

(a)medicinal products that are authorised in more than one member State; and

(b)medicinal products that contain the same active substance or the same combination of active substances and for which a harmonised EU reference date and frequency of submission of PSURs have been established under Article 107c of the 2001 Directive.

Textual Amendments