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Flash VIG-news: ESMYA® (ulipristal acetate 5 mg): revocation of the marketing authorisation

After reviewing the benefit-risk ratio of the medicinal product ESMYA®, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the definitive revocation of its marketing authorisation (MA).

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.

Influenza vaccine: the FAMHP carries out a survey among all pharmacies

The FAMHP continues to closely monitor the distribution of influenza vaccines and is currently conducting a survey among all pharmacies to determine to what extent the planned supply will be enough.

Coronavirus: Belgium agrees on procurement of Janssen's (Johnson & Johnson) vaccine candidate

The European Commission is holding negotiations on behalf of the Member States for procurement procedures for COVID-19 vaccines and is presenting contracts to the Member States. In Belgium, the Advisory Committee responsible for the analysis of the procurement files issued a positive recommendation for Janssen's (Johnson & Johnson) vaccine candidate. The Interministerial Conference (IMC) for Public Health has followed the advice. Belgium will buy the vaccine if a marketing authorisation is granted.

Influenza vaccine: one million doses are still expected and will be distributed to pharmacies between late October and early November

The FAMHP will continue to closely monitor their distribution. In order to provide patients, doctors and pharmacists with the best possible information, the FAMHP collected the most up-to-date information from the three authorisation holders concerned (Sanofi, Mylan, GSK) on the planned delivery dates to wholesaler-distributors. According to this, approximately one third of the planned vaccines must still be delivered.

Influenza vaccine: 10% of the stocks already distributed to the patients, two thirds still to be distributed to (hospital) pharmacies

The FAMHP makes a first assessment of the situation regarding the distribution of flu vaccines. More than half of the vaccines have yet to be placed on the market.

Influenza vaccine: People aged 50 years and over can get the vaccine in pharmacies without prescription

Because of COVID-19, it is even more important to vaccinate at-risk groups, including older people, as widely as possible against seasonal flu. All people aged 50 years and older can get the flu vaccine in pharmacies without a prescription issued by the doctor (general practitioner).

Coronavirus: EMA starts first rolling reviews of COVID-19 vaccines

EMA’s human medicines committee (CHMP), in which the FAMHP takes part, has started the first ‘rolling reviews’ of COVID-19 vaccines. The review concerns the vaccine developed by AstraZeneca and the University of Oxford and the vaccine developed by BioNTech and Pfizer.

Central traceability register: the traceability of certain implants to become compulsory

From 1 May 2021, notification of the insertion or removal of implants will become compulsory for the implants listed in the annex to the Royal Decree of 27.09.2020 relating to the Central Traceability Register (RCT in French). This notification was already possible (but not compulsory) for all implants since 2014.

Coronavirus – a new validation procedure for serological tests

In April 2020, the Belgian Federal Agency for Medicines and Health Products (FAMHP) and Sciensano set up an extraordinary validation procedure for serological tests for SARS-CoV-2. The procedure turned out to be effective during the initial phase of the pandemic. The situation being experienced by the manufacturers and distributors of these tests and by the clinical laboratories carrying out the tests has now returned to normal. This is why a staged return to the conventional way of working is now being implemented.

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