News FAMHP

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Good manufacturing practices for medicinal products available in French and Dutch

Until today, the good manufacturing practices (GMP) for medicinal products were only available in English. As of now, the GMP will be available in French and Dutch on the FAMHP website.

A new BelVet-Sac report confirms the declining use of antibiotics in livestock farming. Two of the three reduction targets have already been achieved.

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: updated privacy notice for GDPR

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).

Off-label use of antibiotics in animals

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.

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.

Using antibiotics in cattle breeding: BelVet-SAC 2016 report

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.

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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