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.
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) .
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.
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.
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
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.
The reporting of adverse reaction contributes to the monitoring of the safety of medicines. Until now there was only a reporting form for physicians, pharmacists and dentists for direct reporting of adverse reactions to the famhp. As foreseen in the new European legislation on pharmacovigilance, a reporting form is now available for patients to enable them to report directly to the famhp any adverse effects after taking medicines.
New legislation on pharmacovigilance for medicinal products for human use: information for healthcare professionals and patients
The new European legislation, which aims at strengthening and rationalizing pharmacovigilance for medicinal products for human use, came into force in July 2012 in the European Union. In this context a number of texts about some concepts of pharmacovigilance are available.
New legislation on pharmacovigilance for medicinal products for human use: information for marketing authorisation holders
The new European legislation, which aims at strengthening and rationalizing EU pharmacovigilance for medicinal products for human use, came into force in July 2012 in the European Union. "Pharmacovigilance - New legislation”, which is accessible via the homepage of the famhp website, gives relevant documents for marketing authorisation holders for medicinal products for human use.
The marketing authorisation (MA) for Mabcampath has been withdrawn at the European level, on the initiative of the MA holder, Genzyme Europe BV, for commercial reasons. Mabcampath is a monoclonal antibody (alemtuzumab) used in some chronic lymphocytic leukaemia. Appropriate access to this medicine will be implemented in each Member State to ensure that patients who are currently benefiting from the treatment can continue.