The telephone contact point of the Marketing Authorisation Division (variations and renewals) will be discontinued as of Friday 16 July 2021. The division can still be contacted by email.

The FAMHP is organising two information sessions on 23 September 2021 and 25 November 2021 for sponsors and applicants of clinical trials about the new Clinical Trial Regulation (CTR). The first information session will take place virtually on 23 September 2021 from 9 a.m. to 12:30 p.m.

During its July 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded a safety signal of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) with COVID-19 vaccines Comirnaty and Spikevax and has recommended that people who have previously had capillary leak syndrome must not be vaccinated with COVID-19 vaccine Janssen.

The FAMHP reminds all sponsors they are obligated to publish the results of their clinical trials in the European Clinical Trials Database (EudraCT) within one year after the end of trial date (or six months for a paediatric trial). Publication on external sources or the transmission of reports to national competent authorities is not sufficient. The guideline applies retrospectively.

The FAMHP reminds marketing authorisation holders of the obligation to add recommendations on the use of contraception to the package leaflet of genotoxic medicines.