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 - Derogation for COVID-19 clinical trials of medicinal products containing or consisting of 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.
In anticipation of the European regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), the FAMHP has updated the “My company” and “My activities” applications in its web portal.
Belgian manufacturers of COVID-19 tests for professional use and Belgian authorised representatives of foreign manufacturers must notify the FAMHP when placing their tests on the market. This notification does not constitute an offer of equipment to the Belgian state. Companies wishing to offer tests to the government must contact the FPS Public Health.
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.
International non-proprietary name (INN) prescriptions: version 8 of the “Operational rules for INN prescriptions in medical and pharmaceutical practice and in the electronic medical record”
The FAMHP's evaluators have finalised version 8 of the note “International non-proprietary name prescriptions – Operational rules for INN prescriptions in medical and pharmaceutical practice and in the electronic medical record”.
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.