The FPS Public Health and the FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified drug Nous-PEV (formed by the experimental drugs GAd-PEV and MVA-PEV) for the treatment of certain lung and skin cancers. The public consultation will run from 10 November 2020 to 10 December 2020.
Submission of dossiers during end-of-year period: final date is 15 December, except for COVID-19 dossiers
During the end-of-year period the FAMHP will be closed from Friday 25 December 2020 up to and including Sunday 3 January 2021. Deadlines have been set for the submission of different types of files.
Influenza vaccine: People aged 50 years and over can get the vaccine in pharmacies without prescription
Because of COVID-19, it is even more important to vaccinate at-risk groups, including older people, as widely as possible against seasonal flu. All people aged 50 years and older can get the flu vaccine in pharmacies without a prescription issued by the doctor (general practitioner).
EMA’s human medicines committee (CHMP), in which the FAMHP takes part, has started the first ‘rolling reviews’ of COVID-19 vaccines. The review concerns the vaccine developed by AstraZeneca and the University of Oxford and the vaccine developed by BioNTech and Pfizer.
In April 2020, the Belgian Federal Agency for Medicines and Health Products (FAMHP) and Sciensano set up an extraordinary validation procedure for serological tests for SARS-CoV-2. The procedure turned out to be effective during the initial phase of the pandemic. The situation being experienced by the manufacturers and distributors of these tests and by the clinical laboratories carrying out the tests has now returned to normal. This is why a staged return to the conventional way of working is now being implemented.
Coronavirus - Derogation for COVID-19 clinical trials of medicinal products containing or consisting of genetically modified organisms
In the context of the COVID-19 crisis, the European Union adopted a regulation providing for a temporary derogation from European legislation on genetically modified organisms.
Coronavirus: the FAMHP is allowing an extension of the payment deadlines expiring before 01.07.2020.
In the context of the coronavirus crisis, the FAMHP is extending all payment periods expiring before 01.07.2020 for all its customers.
The FAMHP is keeping a close eye on the situation on the ground. Consequently, the Alternative Test Protocol (ATP) is being adapted. From now on, it will no longer be possible to sell surgical masks which do not comply with the ATP as comfort masks. One of the parameters has also been refined based on an evaluation of the new test results. Furthermore, masks that have been subject to the ATP must carry a warning on the packaging. The third version of the ATP is applicable from 04.06.2020.
The FAMHP has issued guidelines for checking the compliance and suitability of surgical face masks during the COVID-19 crisis. The guidelines are intended for companies, institutions and authorities that order, sell or use these masks.
Sales of paracetamol remain stable, which is why the restriction of only one box per patient is being lifted. The quotas for pharmaceutical companies and wholesalers have already been abolished. Only the intravenous form remains subject to restriction.