News FAMHP

The results for 2017 confirm the trends of previous years with a reduced use of -7.4% mg active substance/kg biomass compared to last year. This is the biggest annual drop since 2011. Compared to the reference year 2011 it represents a total decrease of -25.9%.

CESP (Common European Submission Portal), the European online system to exchange information between applicants of authorisations and competent authorities will have an update on 29 June 2018 to conform to the new General Data Protection Regulation (GDPR).

The Antimicrobials Working Party from the European Medicines Agency (EMA) has published an important reflection paper on off-label use and the application of the cascade system for antibiotic therapy in animals.

On 30th June 2017 the eighth BelVet-SAC (Belgian Veterinary Surveillance on Antibiotic Consumption) report was published, containing the results of antibiotic use in cattle breeding.

The FAMHP launches PharmaStatus, the new online application that collects information about the availability of medicines in Belgium and makes it public. Current information will help patients, doctors, pharmacists and the pharmaceutical industry to limit the impact of unavailable medicines.

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 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.

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.

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.

Depuis la suspension de l’AMM du vaccin Pregsure BVD décidée par la Commission européenne le 07/10/2010 en raison de l’apparition de cas de pancytopénie bovine néonatale rapportés après l’utilisation de ce vaccin, la firme Pfizer Animal Health, titulaire de l’AMM, n’a pas encore été en mesure de générer des données qui permettraient à la Commission européenne de modifier sa décision. La firme a donc décidé de retirer volontairement l’AMM de ce vaccin en Europe.