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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.

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.

Recall of batches of COCUNE brand mitt-type body wipes

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.

Belgian Koenraad Norga elected as new chair of EMA’s Paediatric Committee

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.

Is the electronic patient information leaflet just as effective as the paper version? e-PIL pilot project evaluation

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.

The European Commission is looking for experts for panels on medical devices and in-vitro diagnostics

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.

EU and US reach milestone in mutual recognition of medicines manufacturers inspections

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.

Update on the new Clinical Trial Regulation pilot project

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

Flash VIG news: reassessment of risk of meningioma on cyproterone

The European Medicines Agency (EMA) is reassessing the risk of meningioma on medicines based on cyproterone, a risk that has long been known to medical professionals. A French study suggests that the risk of meningioma, even though small, can be greater in women who have taken high doses of cyproterone over long periods of time.

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