The European Medicines Agency (EMA) published the ninth ESVAC report (European Surveillance of Veterinary Antimicrobial Consumption) about the sale of antibacterial agents for veterinary use in 2017.
New ESVAC report: antibiotics use falls again in animal breeding in Europe. Further efforts are necessary, in Belgium as well
Update - Unavailability and start or stop of commercialisation: no reporting possible between December 2 and 5, 2019
A new reporting system will be available on December 5, 2019. To avoid errors, reports may only be made through the current system until December 2, 2019.
Information session about PharmaStatus, the new application for reporting and consulting unavailability and start or stops of commercialisation
Via the new online application PharmaStatus, marketing authorization holders can notify the FAMHP of unavailability and start or stop of commercialization of a drug. Marketing authorization holders are invited to an information session on November 18, 2019.
The Federal Agency for Medicines and Health Products (FAMHP) is holding a symposium on vaccines on Friday 6 December 2019. The symposium will highlight certain current challenges in the development of new vaccines and the improvement of existing vaccines. Spekers will also talk about the role of various Belgian public institutions in bringing vaccines to market and monitoring them.
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?
A nitrosamine impurity (NDMA, N-nitrosodimethylamine) has been detected in medicines based on ranitidine. The European Medicines Agency (EMA) has started a review. As a precautionary measure, the companies involved are recalling the medicine or placing the medicines in quarantine.
The Falsified Medicines Directive (FMD), sets forth a number of measures to prevent the introduction of falsified medicines on the market. Thus, all packages of medicines that fall under this regulation must have a unique code and an anti-tampering device (ATD). On packages that do not fall under this obligation, marketing authorization holders can voluntarily attach an ATD. This information is now available in the online medicines database.
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.
At its July 2019 meeting, EMA’s paediatric committee (PDCO) elected Koenraad Norga from Belgium as its new chair, for a three-year mandate starting in September. Professor Norga will replace Dr Dirk Mentzer who is retiring as PDCO Chair, having served the maximum of two three-year mandates.
Marketing authorization (MA) holders can now also use the FAMHP’s post box address in product information
When reporting side effects in the product information, one can now refer to the FAMHP’s post box address.