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News
After a period of limited availability, the Gardasil 9 vaccine, used to prevent Human Papillomaviruses (HPV), is available to everyone again.
During its meeting of September 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended the revocation of marketing authorisation of ulipristal acetate for uterine fibroids.
At the initiative of the FAMHP, a consultation took place on 3 September 2020 with the representatives of the clinical laboratories and Sciensano, during which the FAMHP explained the method for the validation of all serological tests for COVID-19. After the consultation, all parties decide that it is advisable to organize better consultation and more intensive cooperation between government and clinical laboratories.
On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. These measures have now been extended by one month.
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.