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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?

Good distribution practices of medicinal products : update of questions and answers regarding GDP legislation

The FAMHP Distribution division updates the list of questions and answers on rules of Good Distribution Practices (GDP) of medicinal products for human use.

Watch out for identity theft for the illegal obtention of drug precursors

The FAMHP was confronted with a case of identity theft whereby company details where abused for the illegal obtention of drug precursors.

European Commission on the lookout for experts on medical devices and in-vitro diagnostic medical devices

These experts will form panels, providing advice and evaluating new devices that present a risk.

Brexit: European Commission reminds enterprises to be well prepared

Brexit is coming very shortly. And it will have great consequences for many Belgian companies.

Ranitidine: recall of medicines

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.

6th Vigilance Day on 15 October 2019

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.

Information on the Falsified Medicines Directive available in the online medicines database

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.

Falsified Medicines Directive: end of transition period and beginning of monitoring activities

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.

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