The FAMHP Medication errors working group has received 112 notifications of proven or potential errors since 2016. Thanks to these notifications, corrective or preventive measures were put in place, in collaboration with the pharmaceutical industry. The Agency encourages healthcare professionals and patients to report any actual or potential medication error.
Coronavirus: EMA receives first two applications for conditional marketing authorisation of COVID-19 vaccines
The European Medicines Agency (EMA) received applications for a conditional marketing authorisation (MA) for Pfizer/BioNTech's candidate vaccine and Moderna's candidate vaccine. The evaluation of the candidate vaccines will be performed under accelerated assessment. An evaluation on the marketing authorisation could be issued within weeks, depending on whether the submitted data are sufficiently robust and complete to prove the quality, safety and effectiveness of the vaccines.
Priority for category A has been extended, but vaccines already distributed to category B can be administered.
Coronavirus: the Inter-Ministerial Conference on Public Health agrees on the European procurement procedure for Moderna vaccine candidate and finalizes COVID-19 vaccination strategy
The Inter-Ministerial Conference (IMC) on Public Health held another meeting today to discuss the different aspects of approach of the COVID-19 pandemic.
Flash VIG-news: Trisenox (arsenic trioxide): risk of medication errors due to the introduction of a new concentration of 2 mg/ml
The FAMHP warns healthcare professionals prescribing, delivering and administering Trisenox about the risk of dosing errors as a new presentation of the medicine is launched on the market.
Based on the risk to the consumer, the Joint Commission’s Chamber for products for human considers Killapods nicotine pouches medicinal product by function.
The European Medicines Agency will organise a public meeting on 11 December 2020 to inform European citizens about the EU regulatory processes for the approval of COVID-19 vaccines and the Agency’s role in their development, evaluation, approval and safety monitoring. The public will also have the opportunity to express their views.
Brexit: the FAMHP reminds marketing authorisation holders of the end of the transition period for submitting variations
Marketing authorisation holders (MAHs) are reminded that it is their responsibility to make the necessary changes to their dossiers and to submit the necessary variations before 31 December 2020.
Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages
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.
The European Commission is conducting negotiations on behalf of the Member States for procurement procedures for COVID-19 vaccines and is submitting contracts to the Member States. In Belgium, the Advisory Committee responsible for the analysis of the procurement files issued a positive recommendation for CureVac vaccine candidate. The Inter-ministerial Conference (IMC) on Public Health of 24 November 2020 then made a decision. Belgium will buy the vaccine if a marketing authorisation is granted.