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.
Discontinuation of the telephone contact point of the Marketing Authorisation Division (variations and renewals)
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.
FAMHP organises two information sessions, in collaboration with its stakeholders, for sponsors and applicants on 23 September 2021 and on 25 November 2021 on the new Clinical Trial Regulation (CTR).
The medicinal product Bleomycine Sanofi 15,000 IU, used in the treatment of certain cancers (testis, throat, mouth, Hodgkin's disease and non-Hodgkin's lymphoma), is currently in limited availability. While waiting for a sufficient quantity of the medicinal product to return to the market, the FAMHP experts recall the recommendations for the rational use of stocks of Bleomycine Sanofi 15,000 IU that may still be available.
The FAMHP has once again renewed a number of measures in a new decision by the Chief Executive Officer of the FAMHP. This decision has once again been taken to avoid medicine shortages in the context of the coronavirus pandemic (COVID-19).
PRAC June 2021 – EMA advises on Vaxzevria (COVID-19 Vaccine AstraZeneca) and update on ongoing evaluation of COVID-19 vaccines
During its June 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) advises against use of Vaxzevria in people with history of capillary leak syndrome. The PRAC is also continuing its assessment of reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) in a small number of people following vaccination with COVID-19 vaccines.
During its May 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) reviewed a number of safety signals related to COVID-19 vaccines. The evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks.
Close monitoring of medicine stocks proved particularly useful during the COVID-19 pandemic. The FAMHP managed to act proactively and find solutions in time. The monitoring was done manually, but is now automated using a new Stock Monitoring Tool.
PRAC April 2021 – Conclusions and additional review on Vaxzevria (AstraZeneca’s COVID-19 vaccine), and new investigations on COVID-19 Vaccine Janssen
During its April 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded on very rare cases of unusual blood clots with low blood platelets reported with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) and started reviewing a safety signal of capillary leak syndrome in patients vaccinated Vaxzevria. Furthermore, the PRAC is also investigating thromboembolic events reported following vaccination with COVID-19 Vaccine Janssen.
Pilot project on Clinical Trial Regulation (CTR): webinar on the new temporary procedure for submission of initial dossiers
From mid-February 2021, a reservation system with time slots will be used for the submission of initial dossiers for the Clinical Trial Regulation (CTR) pilot project. This procedure will be explained during a webinar on 4 February 2021 at 2 PM.