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Symposium on the new European legislation on veterinary medicines.

Europe has approved new legislation on veterinary medicines and medicated animal feeds. What does this mean and what will change concretely for the industry or veterinarian?

Save the date: Symposium on the new European legislation on veterinary medicines. What will change for you?

Europe has approved new legislation on veterinary medicines and medicated animal feeds. What does this mean and what will change concretely for the industry or veterinarian? Learn everything at the FAMHP symposium on November 19.

Holders of marketing authorizations must check their data in the EMA’s article 57 database

The Vigilance Division of the FAMHP has found encoding errors in the article 57 database of the EMA. The FAMHP is asking holders of a marketing authorization for a medicine to carefully check that their registered data are correct.

Recognition of the FAMHP by the American Food and Drug Administration (FDA)

The American Food and Drug Administration (FDA) has recognised the FAMHP as its Belgian counterpart under the mutual recognition agreement (MRA) between the European Union and the United States.

New ESVAC report: European monitoring of antibiotic use in animals. Reduced usage but Belgium must continue to make efforts

The European Medicines Agency (EMA) published the eighth ESVAC (European Surveillance of Veterinary Antimicrobial Consumption) report on the sale of antibacterials for veterinary use in 2016.

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.

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