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Circulaire 596 relative aux activités de production et de distribution des médicaments expérimentaux
Dans la circulaire 596, l’afmps rappelle aux professionnels de la santé concernés les exigences relatives aux activités de production et de distribution des médicaments expérimentaux et clarifie sa position sur les notions de dispensation, de conditionnement et de reconstitution de ces médicaments.
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Report de l’obligation, pour les grossistes et les pharmaciens, d'enregistrer le numéro de lot de chaque médicament distribué et délivré.
Pour lutter contre les médicaments falsifiés, une directive européenne prévoit de mettre sur les emballages des médicaments à usage humain des dispositifs de sécurité pour permettre de vérifier leur authenticité et d’assurer leur traçabilité. L’obligation pour les grossistes et les pharmaciens d’enregistrer le numéro de lot de chaque médicament distribué et délivré, actuellement prévue par la législation belge, est reportée jusqu’à ce que l’application des dispositifs de sécurité soit définie au niveau européen.
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Domperidone : réévaluation de la balance bénéfices/ risques
A l’initiative de l’agence belge des médicaments et des produits de santé (afmps), l’agence européenne des médicaments (EMA) a commencé la réévaluation de la balance bénéfices/ risques des médicaments contenant de la dompéridone. L’EMA va analyser toutes les données disponibles relatives aux effets indésirables cardiaques de la dompéridone afin de pouvoir formuler un avis sur les mesures éventuelles à prendre.
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VIG-NEWS: January 2013 Edition
The new edition of the electronic newsletter "VIG-NEWS" of the federal agency for medicines and health products (famhp) is now available. The VIG-NEWS is a selection of recent news concerning pharmacovigilance from different sources.
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Validation of registration dossiers: a new version of the checker
The checker currently used in the FAMHP for technical validation of submitted registration dossiers concerning medicines for human use has been adjusted to take account of restrictions and controls as specified in the "non e-CTD Electronic Submission” (Nees). The automated mails were also adapted.
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Electronic submissions of applications for marketing authorisations for human medicinal use through CESP
Starting on 29 October 2012 it will be possible to submit electronic applications for marketing authorisations in the national procedure, Mutual Recognition Procedure (MRP) or Decentralised procedure (DCP) through the improved Common European Submission Platform (CESP) .
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Publication of the new Royal Decree regarding requests for national scientific-technical advice (STA)
The Royal Decree of July 16th 2012 updates the definitions, procedures and fees that are applicable to requests for national scientific-technical (eg. regulatory) advice (STA). These requests are being treated by the unit for STA within the Directorate-General (DG) PRE-Authorisation of the famhp. This Royal Decree modifying the Royal Decree of March 31st 2009 in execution of Article 6sexies of the Belgian Medicines law of March 25th 1964, was published in the “Moniteur Belge” on October 8th 2012 and entered into force on October 18th 2012.
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Codeine: on-going reassessment at the European level
The European Medicines Agency (EMA) has decided to reassess the benefit / risk balance of codeine-containing medicines in the context of their use in postoperative pain relief among children. Rare cases of respiratory depression have indeed been observed in children who rapidly metabolize codeine into morphine.
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Transparency: active and passive public announcements
Since March 2012 the famhp has been publishing information on advisory committees that it has set up internally. Currently available information covers the mission, the composition, the house rules and the dates of the meetings of six commissions. As announced in the press release of 9th March 2012, agendas and reports are also published for three of these commissions. These are “active public announcements”. Any administrative document in the possession of the FAMHP may also be requested (passive public announcements) as long as they do not contain confidential information. The famhp has prepared a document setting out the rules applicable in this matter.
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Authorization for medicinal products: a new strategy for the decentralized procedure with Belgium as the reference member state
Firms wishing to submit an application for marketing authorisation (MA) of a medicine under the decentralised procedure by choosing Belgium as the reference member state must take into account the new strategy put in place by the FAMHP in order to book a timeslot for this type of file.
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Cette section présente les différentes nouvelles émises par l'AFMPS...
