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Soumission électronique des dossiers d’AMM des médicaments à usage vétérinaire : nouvelle version du checker

A partir du 1er juillet 2013, la nouvelle guideline « vNeeS » et les nouvelles règles de validation entreront en vigueur pour les dossiers d’autorisation de mise sur le marché (AMM) des médicaments à usage vétérinaire. Le « checker » correspondant utilisé pour la validation technique de ces dossiers a fait l’objet d’un « release » de maintenance (v 2.2.a) pour en tenir compte.

The antimicrobials for veterinary use: vigilance

The indiscriminate and excessive use of antibiotics in veterinary medicine presents a risk to public health and animal health because it promotes the emergence of resistant strains of bacteria. To promote a fair and reasonable use of these medicines and educate veterinary professionals to this problem, the famhp collaborates with the University of Gent to monitor the consumption rates of antibiotics in the veterinary sector based on distribution data. The fourth BelVet-Sac report (Belgian Veterinary Surveillance of Antibiotic Consumption) is now available.

Medicines for veterinary use: new QRD (Quality Review of Documents)

Within the European Medicines Agency, the Coordination group for Mutual Recognition and Decentralized Procedures – veterinary medicines (CMDv), and the "Quality Review of Documents "(QRD) Working Group reviewed at the end of 2012 the templates for the Summary of Product Characteristics (SPC), package leaflet and labelling of veterinary medicines. The "QRD" templates Version 8 are now available.

Survey of external satisfaction

The federal agency for medicines and health products (famhp) will soon launch a first satisfaction survey to assess the quality of its services and products. The results of this will be communicated at the end of 2013 and will be used to improve the delivery of FAMHP services.

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