Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked all marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution. The result of this risk assessments must be reported via the particular web form, before 31 March 2021 for chemical medicinal products and before 1 July 2021 for biological medicinal products. MA (marketing authorisation) variations must be submitted before 26 September 2022 (chemical medicinal products) and before 1 July 2023 (biological medicinal products).
The European Commission negotiated the contract with AstraZeneca for the purchase of their candidate vaccine against COVID-19. In Belgium, the advisory committee responsible for the analysis of the purchase files for COVID-19 has previously given a positive opinion.
The European Commission is negotiating on behalf of the Member States for the purchase procedures of vaccines against COVID-19 and submitting contracts to the Member States. An advisory committee has been set up to analyse purchase dossiers on the basis of various criteria. A first dossier has now been treated.
COVID-19 makes it important to be able to vaccinate at-risk groups to the maximum extent possible in order to avoid overburdening the healthcare sector. Therefore, influenza vaccination for 2020-2021 will be phased in, giving priority to those at risk.
Recent articles in the media have once again questioned the reliability of the serological tests bought by the government, in particular the DiaSorin test. The FAMHP is clear: on the basis of current scientific knowledge, this test meets all requirements and can be used without any problems.
Because of the benefits to both patients and healthcare professionals, a study on the use of saliva samples as an alternative to sampling via a deep nasal swab (nasopharyngeal) to detect SARS-CoV-2 using molecular detection tests (PCR) was launched on 28 May 2020.
On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. Following new information from scientific research, the FAMHP has added dexamethasone-based medicines and raw materials to the list of medicinal products subject to emergency measures.