Follow-up of final study reportsU.K.
202.—(1) This regulation applies [F1in respect of a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation] where—
(a)the Pharmacovigilance Risk Assessment Committee has made recommendations concerning an authorisation or registration or a class of authorisations or registrations based on a final study report under Article 107q(1) of the 2001 Directive; and
(b)an agreement on the action to be taken in respect of the authorisation or registration or the class of authorisations or registrations has been reached by the co-ordination group under the procedure laid out in Article 107q(2) of the 2001 Directive (“the agreement”).
(2) The licensing authority must implement the measures set out in the agreement in accordance with the implementation timetable determined in the agreement.
(3) Paragraph (4) applies where—
(a)the agreement requires a variation to be made to one or more authorisation or registration; and
(b)the terms of the agreement are known to the holder or holders for the product or products which is, or which are, the subject of the agreement.
(4) Where this paragraph applies, each holder must submit to the licensing authority in accordance with the terms of the agreement (including its implementation timetable) an application for a variation including—
(a)an updated summary of the product characteristics; and
(b)an updated package leaflet.
(5) This regulation is subject to regulation 212 (transitional arrangements).
Textual Amendments
F1Words in reg. 202(1) inserted (31.12.2020) by S.I. 2019/775, reg. 162 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 130)