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The FAMHP Distribution division updates the list of questions and answers on rules of Good Distribution Practices (GDP) of medicinal products for human use.
The FAMHP was confronted with a case of identity theft whereby company details where abused for the illegal obtention of drug precursors.
These experts will form panels, providing advice and evaluating new devices that present a risk.
Brexit is coming very shortly. And it will have great consequences for many Belgian companies.
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.
On Tuesday, October 15, 2019, the Vigilance Division of the Federal Agency for Medicines and Health Products (FAMHP) is organising a Vigilance Day in Brussels for the sixth time.
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.
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.