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Follow-up of the Marketing Authorisation dossiers for medicinal products

A steering committee was established to develop an action plan to improve the performance of the Federal Agency of Medicines and Health Products (FAMHP) in managing the marketing authorisation (MAAMM) for medicines for human use. Circular 542 for the attention of MA-holders presents this action plan. Among the 8 actions proposed, 4 come into force on 01/07/2009.

Dextropropoxyphene: recommendation of the European Medicines Agency (EMEA)

Following the identified risk of potentially fatal overdose of dextropropoxyphene, the Committee for Medicinal Products for Human Use (CHMP) of the EMEA recommends the gradual withdrawal of the marketing authorizations for medicines containing dextropropoxyphene. They are currently available in Belgium under the names Depronal (dextropropoxyphene alone) and Algophène (dextropropoxyphene and paracetamol). The recommendation of the EMEA has been forwarded to the European Commission for a decision. Once the decision is made, a timetable for withdrawal of the Belgian market of these drugs will be determined and communicated.

eSubmission of the marketing authorisation (MA) dossiers for medicines

The national « guideline » concerning the electronic submission of the MA dossiers for medicines for human use has been updated. The new version (2.8) of the document « eSubmission guideline » is now available.

Validation of the registration files for medicines for human use: new version of the checker

In the previous version of the checker some small errors have been detected. They have been solved in the new version 2.6.a.

Clopidogrel (PLAVIX): possible interaction with proton pump inhibitors

Studies suggest that clopidogrel, authorised and marketed in Belgium as PLAVIX, may be less effective in patients receiving proton pump inhibitor (PPI) (esomeprazole, lansoprazole, omeprazole, pantoprazole ou rabeprazole).

Validation of the registration files for medicines for human use: checker installation kit

The installation kit of the new checker released 8 May 2009, contains a wrong Java version (1.5). The correct version (1.6) has been installed in the kit today. This allows you to install the checker without problems.

Information session for applicants for marketing authorisation (MA) for medicinal products for human use (General Association of Pharmaceutical Manufacturers) and FeBelGen (Federation of Belgian generic drugs companies)are oranising, in collaboration with the Federal Agency for Medicines and Health products (FAMHP) an information session on how to manage applications for Marketing Authorisation for medicinal products for human use. This will take place in Evere on Tuesday 19 May 2009.

Public consultation on the use of a genetically modified organism in a clinical study

The Federal Agency for Medicines and Health Products and the Federal Public Service Health, Food Chain Safety and Environment inform the population of a clinical study with a genetically modified drug against cancer of the cervix by the firm Roche.

Registration file validation : New release of checker

The checker currently used within the FAMHP for technical validation of all submitted registration dossiers concerning medicinal products for human use has been adapted in order to comply with new legislation.

Launch of the new service for national scientific-technical advice (STA)

The Directorate-General (DG) PRE-Authorisation of the Federal Agency for Medicines and Healthcare Products (FAMHP) has implemented a new, centralized service to address requests for national scientific and/or technical (eg. regulatory) advice (STA) related to the research and development of human or veterinary drug products in view of potential clinical trial applications (CTA’s), marketing authorization applications (MAA’s) or introduction of variations to marketed drug products.

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