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The transition period for the implementation the Falsified Medicines Directive (FMD) ends on September 1, 2019. From that time, alerts will be centrally evaluated and the FAMHP will start the monitoring activities through which violations and non-conformities will be followed up. 

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.

Certificates for Good Manufacturing Practice or Good Distribution Practice can be queried in the EudraGMDP database. The FAMHP will no longer automatically provide paper versions of these certificates, only upon request.

The FAMHP would like to inform consumers and patients of a recall by Stöpler Medical B.V. concerning COCUNE brand mitt-type body wipes. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.

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.

When reporting side effects in the product information, one can now refer to the FAMHP’s post box address.

Last year, the e-PIL pilot project on the electronic patient information leaflet started. Hospital pharmacists will soon receive a link to an online survey to evaluate the project, one year after its start.

Later this year, the European Commission will launch a call for experts in medical devices and devices for in-vitro diagnostics. They will form expert panels to provide advice and assess new risky devices. 

The U.S. Food and Drug Administration (U.S. FDA) has recognized all 28 EU member states. This means that starting 11 July 2019, the United States (US) and the European Union (EU) have fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories. 

The FAMHP is updating the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials in Belgium.