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Medicines containing zolpidem: revaluation

The European Medicines Agency (EMA: European Medicines Agency) has initiated a procedure of reassessment of zolpidem-containing medicines, used for the symptomatic treatment of insomnia (sleeping difficulty). This review has been made in response to concerns related to the onset in some patients of drowsiness and slow reactions the day after taking the medicine, and a potential increased risk of accidents during activities requiring alertness (e.g. when diving).

Solutions for infusion containing hydroxyethyl starch: new revaluation

In June 2013 the PRAC adopted recommendations on HES solutions under Article 31 of Directive 2001/83/EC. A number of marketing authorization holders called for a review of these recommendations. Following the suspension of the use of these medicines in the United Kingdom since 27th June, the EMA has launched a new "urgent" reassessment procedure in accordance with Article 107i of Directive 2001/83/EC. Pending the outcome of these procedures, the recommendations of the PRAC still apply (see press release of 18th June 2013).

Tetrazepam-containing medicines: suspension of the marketing authorization and withdrawal from the market

The famhp sent to the firms concerned the decision of the European Commission of 29th May 2013 to suspend the marketing authorizations (MA) of the tetrazepam-containing medicines throughout the European Union. A recall of all batches of the involved medicines marketed in Belgium (EPSIPAM, MYOLASTAN and TETRAZEPAM EG) must be made by 1st September 2013.

Derivatives of ergot-containing medicines: new restrictions

The Committee for Medicinal Products for Human Use of the European Medicines Agency has reviewed all available data on derivatives of ergot-containing medicines. This Committee believes that their benefit / risk balance is most favorable in the treatment of circulatory disorders, cognitive and neuro-sensory disorders as well as in the prevention of migraine. It recommends that physicians reassess the treatment of patients to whom these drugs are prescribed.

Organization charts of the DG’s at the famhp

The organization charts corresponding to each of the different Directorates General (DG’s) of the famhp has been drawn up. The three charts (DG PRE authorization, DG POST authorization and DG inspection) are now available on the famhp site.

Falsified medicines: new legislation

Directive 2011/62/EU aimed at ighting against falsified medicines was transposed into Belgian law: the law of 20th June 2013 amending the Law of 25th March 1964 on medicines was published in the Belgian Official Journal on 26th June. Many of these provisions come into force on 1st and 2nd July 2013.

Belgian participation in PANGEA VI, an international annual event aimed at fighting against the online sale of counterfeit and illegal medicines.

From 18th to 27th June 2013 a new action programme - Pangea VI - coordinated at the international level and aimed at the online worldwide sale of counterfeit medicines and illegal medicines took place once again. This action was coordinated by Interpol, conducted together with the World Customs Organization (WCO), the Permanent Forum on International Pharmaceutical Crime (PFIPC), the Heads of Medicines Agencies Working Group of Enforcement Officers (HMA WGEO), the Pharmaceutical Security Institute (PSI), Europol and supported by the Center for Safe Internet Pharmacies and private companies including Visa, Mastercard, PayPal and LegitScript.

Soumission électronique des dossiers d’AMM des médicaments à usage vétérinaire : nouvelle version du checker

A partir du 1er juillet 2013, la nouvelle guideline « vNeeS » et les nouvelles règles de validation entreront en vigueur pour les dossiers d’autorisation de mise sur le marché (AMM) des médicaments à usage vétérinaire. Le « checker » correspondant utilisé pour la validation technique de ces dossiers a fait l’objet d’un « release » de maintenance (v 2.2.a) pour en tenir compte.

Validation des dossiers électroniques d’AMM des médicaments à usage humain : version « intermédiaire « du « checker ».

Le checker utilisé pour la validation technique des dossiers d’autorisation de mise sur le marché (AMM) des médicaments à usage humain a été adapté pour tenir compte des nouvelles règles de validation du NeeS (non eCTD electronic Submission) qui seront d’application à partir du 01/09/2013 . Une version « intermédiaire » (v.4) du checker a été développée. Les demandeurs qui le souhaitent peuvent appliquer les nouvelles règles à partir du 1er juillet 2013 et doivent alors utiliser cette version intermédiaire du checker.

Validation of the electronic MA files for medicines for human use: “Intermediate” version of the "checker".

The checker used for the technical validation of market authorization files (MA) for medicines for human use has been adapted to reflect the new validation rules NeeS (non-eCTD electronic Submission) that will apply to from 01/09/2013. An "intermediate" (v.4) version of the checker has been developed. Applicants may wish to apply the new rules from 1st July 2013 and must then use this intermediate version checker.

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