VIII.C.3. Changes to the marketing authorisation following results from a non-interventional post-authorisation safety study

The marketing authorisation holder shall submit a final study report to the national competent authority or the PRAC as applicable within 12 months of the end of data collection unless a written waiver has been granted [DIR Art 107p(1)].

The marketing authorisation holder shall evaluate whether the study results have an impact on the marketing authorisation and shall, if necessary, submit to the national competent authorities or the Agency an application to vary the marketing authorisation [DIR Art 107p(2)]. In such case, the variation should be submitted to the national competent authority or the Agency.

Following the review of the final study report, the PRAC or a national competent authority in a Member State may recommend variation, suspension or revocation of the marketing authorisation [REG Art 28b(2), DIR Art 107q(2)]. The recommendation by the PRAC shall mention any divergent positions and the grounds on which they are based [DIR Art 107q(1)].

Where at least one centrally-authorised product is concerned by the final study results, the recommendation made by the PRAC shall be transmitted to the CHMP which shall adopt an opinion taking into account the recommendation. When the opinion of the CHMP differs from the recommendation of the PRAC, the CHMP shall attach to its opinion a detailed explanation of the scientific grounds for the differences [REG Art 28b(2)].

Where nationally authorised products are concerned by the final study results, the Member States represented within the CMDh shall agree a position taking into account the PRAC recommendation and include a timetable for the implementation of this agreed position. When a consensus agreement is reached, the agreed position shall be sent by the CMDh to the marketing authorisation holder and Member States which should adopt necessary measures to vary, suspend or revoke the marketing authorisation in line with the implementation timetable of the CMDh. In case a variation is agreed upon, the marketing authorisation holder shall submit to the national competent authorities an appropriate application for a variation, including an updated summary of product characteristics (SmPC) and package leaflet within the determined timetable for implementation [DIR Art 107q(2)]. In case an agreement by consensus cannot be reached, the position of the majority of the Member States represented within the CMDh should be forwarded to the Commission who shall apply the procedure laid down in DIR Art 33 and 34 [DIR Art 107q(2)].

Where the agreement or position of the CMDh differs from the recommendation of the PRAC, the CMDh shall attach to the agreement or majority position a detailed explanation of the scientific grounds for differences together with the recommendation [DIR Art 107q(2)].

More urgent action may be required in certain circumstances, for example, based on interim results included in progress reports (see also VIII.B.4.3.1.). In such case, an appropriate procedure will be initiated (see GVP Module VI).