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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: good practices when changing consumables used with COVID-19 patient ventilators

In order to help healthcare professionals and support hospitals in their processes, the FAMHP is publishing guidelines on changing consumables (filters, etc.) used in the ventilation of COVID-19 patients.

Operation PANGEA XIII: Belgian customs and the FAMHP seize 203 packages containing over 23 000 illicit or counterfeit products

The FAMHP, in collaboration with Belgian customs, took part in the international Operation PANGEA XIII from 3 to 10 March 2020. This operation, coordinated by INTERPOL, specifically targets the interception of illicit and counterfeit medicinal products and devices. In Belgium, inspections were performed at the Zaventem and Bierset control points.

Recommendations for paclitaxel-coated balloons and paclitaxel-eluting stents in the treatment of peripheral arterial disease

A scientific article has raised concerns about paclitaxel-coated balloons and paclitaxel-eluting stents used in the treatment of peripheral arterial disease (PAD). In response, the Federal Agency for Medicines and Health Products (FAMHP) hereby makes its recommendations.

Flash VIG-news : INSULINS in prefilled pens and cartridges for reusable pens: new recommendations

Following an alert from the United Kingdom's National Health Service (NHS), the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) analysed reports of incidents linked to the extraction of insulin from prefilled pens and cartridges for reusable pens with the aid of a syringe. This practice can increase the risk of medication error and lead to dysglycaemia. However, until today, only the package leaflets of certain insulins mentioned the possibility of such extraction.

Information sessions on auto control of the sector of medical devices - 8th September and 2nd October 2017

The Directorate-General INSPECTION of the FAMHP organises two information sessions on Friday 8th September and Monday 2nd October 2017 in the Storck room, SPF Emploi, 1 rue Ernest Blerotstraat, 1070 BRUSSELS.

Dispositifs de fermeture de communication interauriculaire fabriqués par NMT Medical, Inc. : recommandation

L’Agence Fédérale des Médicaments et des Produits de Santé (AFMPS) a été informée par les autorités suisses que l’entreprise américaine NMT Medical, Inc., qui fabriquait des dispositifs médicaux de fermeture des communication interauriculaire, a déposé son bilan en avril 2011. Suite à cette fermeture, les exigences légales, notamment en matière de surveillance du marché, ne sont plus respectées. Il est donc recommandé de ne plus utiliser ces dispositifs.

Implants mammaires de POLY IMPLANT PROTHESE : suivi et conclusions

En avril 2010, l’AFMPS a publié un communiqué relatif aux implants mammaires fabriqués par la société Poly Implant Prothèse (P.I.P.). Elle demandait alors aux distributeurs de ces implants, aux pharmaciens, aux médecins et aux personnes qui en détenaient d’en arrêter la distribution, la délivrance, l’utilisation et l’exportation, étant donné que le gel de silicone utilisé ne correspondait pas au gel approuvé. En novembre 2010, l’AFMPS a publié un nouveau communiqué pour relayer les premiers résultats des tests réalisés par l’Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS). Récemment, l’AFSSAPS a publié les derniers résultats et ceux-ci confirment les

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