An applicant for a parallel import authorisation of a medicine must now submit to the famhp the PIL draft accompanied by a form containing the information required by the regulation. This information no longer needs to be included in the PIL itself which must correspond to the latest version of the reference medicine leaflet. The PIL to which the completed form is attached on the first page shall, after approval, be attached to the parallel import authorisation.
The European Medicines Agency (EMA) does not recommend long-term use of calcitonin-containing medicines (MIACALCIC and STEOCALCIN) due to an increased risk of cancer. Moreover, the benefits of these medicines do not outweigh their risks in the treatment of postmenopausal osteoporosis. Only the nasal spray is used for this indication; EMA recommends removing this presentation from the market. The Belgian authorities will take the necessary action when the European Commission has made a decision about it.
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.
Counterfeit and illegal medicines are potentially dangerous to health because they offer no guarantee of quality, safety and efficiency. Recently melanotan-containing products are available on the internet to give an artificial tan. These products are fraudulent and represent a real risk to health. FAMHP warns people against buying these products and reminds them of the message of its campaign: "Medicines via the internet! Do not surf with your health! ".
The European Medicines Agency informs doctors that the currently recommended dose of DORIBAX for the treatment of nosocomial pneumonia may be not sufficient in severe cases. A letter for the attention of health professionals will be sent to prescribers informing them of these new recommendations.
The framework law of 29th March 2012 contains an adaptation of the tax system to finance the missions of the Federal Agency for Medicines and Health Products. These changes are in line with the new requirements for pharmacovigilance at the European level. Circulars 588 and 589 provide practical information about it.
New circular 586 on the reporting of adverse events observed in clinical trials and submission of annual safety reports.
A new version of the "Detailed guidance on the collection, verification and presentation of adverse event / reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)" was published in June 2011. More information on the way these guidelines will be put into practice in Belgium is now published in circular 586.
Suitable candidates for this function can apply, via Selor, until 18th June 2012. All the required information can be found in the call for applications on the Selor website.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency continues to regularly evaluate all available data concerning the risk of serious bleeding following administration of Pradaxa. The benefit of this anticoagulant medicine continues to outweigh the risks, but the CHMP considers it necessary to give clearer recommendations for prescribers and patients to better control the risk of bleeding associated with the administration of this medicine.
The French authorities have reassessed the veterinary medicines used to prevent and / or combat ectoparasites (fleas and ticks), which have been authorized in France through the national marketing authorization procedure. A potential danger to children was highlighted if they have prolonged and repeated contact with a pet wearing an antiparasitic collar containing dimpylat, tertrachlorvinphos or propoxur. The Belgian authorities are waiting for a European decision on the matter and recommend caution.