The applicant or marketing authorisation holder for a generic medicine may decide not to include the patented indications or dosage forms in the marketing authorisation and not to mention them in the summary of product characteristics and package leaflet. Applicants/marketing authorisation holders must follow specific procedures to remove or reinsert the patented indication.

The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified vaccines ChAd155-hIi-HBV and MVA-HBV for the treatment of infections with the hepatitis B virus (HBV). The public consultation will run from 27 November 2021 to 27 December 2021.

In the context of the preparation of the implementation of the Clinical Trials Regulation (CTR), which will come into force on 31 January 2022, a specific webinar for SMEs and academic sponsors on key aspects of the CTR and the new processes via the Clinical Trials Information System (CTIS) for clinical trial application submissions will be organised on 29 November 2021.

Since 25 March 2020, shortened deadlines have been used for applications for clinical trials with medicinal products for the treatment or prevention of COVID-19. As the vaccination campaign has reached the majority of the population, these reduced timelines are extended to 15 calendar days.

During the end-of-year period, the FAMHP will be closed from Monday 27 December 2021 through Friday 31 December 2021. Deadlines have been set for the submission of different types of dossiers.

During its November 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has made un update on COVID-19 vaccines and concluded a safety signal for Imbruvica.

The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified vaccine VSV-GP128 to treat colorectal cancer. The public consultation will run from 1 November 2021 to 1 December 2021.

During its October 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a review of meningioma risk with nomegestrol- and chlormadinone-containing medicines. The PRAC also has reviewed data on venous thromboembolism and immune thrombocytopenia with COVID-19 vaccines.