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Coronavirus: updated guidelines for verifying the compliance and suitability of surgical face masks

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.

Coronavirus: relaxation of paracetamol measures for pharmacists and patients

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.

Making COVID-19 tests available in Belgium

The FAMHP no longer provides specific validation or verification procedures for COVID-19 tests, nor are there any restrictions for making these tests available on the Belgian market.

Coronavirus: new version of Alternative Test Protocol (ATP) for surgical face masks

An Alternative Test Protocol (ATP) has been developed for surgical face masks that do not have the necessary declarations, certificates and test reports. In the event of a positive result, this protocol still allows them to be used as a surgical mask or comfort mask. Test results are now also made public.

Coronavirus: Belgian guideline for the management of clinical trials during the coronavirus pandemic

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

Directive on the direct dispensing of medicinal products to patients in the context of clinical trials

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.

COVID-19: electronic files submission

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.

Give us your opinion on genetically modified vaccines against HPV infections (Human Papilloma Virus)

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.

Pilot project on simultaneous national scientific advice starts 1 February 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.

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