PART 11Pharmacovigilance

Post-authorisation safety studies

Follow-up of final study reports202

1

This regulation applies 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).