News FAMHP

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.

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).

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.

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.

A national guideline is available to complement European guidelines for the management of clinical trials during the coronavirus pandemic.

Due to the coronavirus problem and potentially overloaded hospitals, it may be difficult or undesirable for a patient participating in a clinical trial to obtain their investigational medicinal product (IMP) at the hospital. The FAMHP provides guidelines on this subject.

Following the recommendations of the Belgian National Security Council regarding the coronavirus epidemic, the FAMHP encourages employees to work more from home. Therefore, we ask all our partners to submit their files to us electronically as much as possible.

The FPS Public Health and the FAMHP invite you to take part in the public inquiry on a clinical trial with genetically modified vaccines ChAdOx1-HPV and MVA-HPV against HPV infections (Human Papilloma Virus). The public inquiry runs from March 4, 2020 through April 3, 2020.

The EU-Innovation Network announces a pilot project for simultaneous national scientific advice (SNSA) to strengthen early regulatory support for innovation. The pilot project kicks off with developing a best practice model starting 1 February 2020.

When reporting side effects in the product information, one can now refer to the FAMHP’s post box address.