News FAMHP

In the context of vaccination against bluetongue disease animal health professionals are encouraged to report any problems to the Federal Agency for Medicines and Health Products (FAHMP) and in particular the anaphylactic reactions. For these reactions a research programme is proposed: a clinical checklist associated with blood tests must be returned to ARSIA (Association Régionale de Santé et d'Identification Animale).

The Royal Decree (RD) of 10 March 2009 amending the Royal Decree of 18 June 1999 establishing fees to fund the missions of the administration relating to narcotic drugs and psychotropic substances was published in the “Moniteur belge” on 30 March 2009. This RD will enter into force 10 days after its publication. The new amounts will therefore take effect from Thursday 9 April 2009.

The Belgian Centre for Pharmacovigilance for drugs for Human use (BCPH) of the Federal Agency for Medicines and Health Products (FAMHP) has launched a new version of the well-known “yellow card”. The yellow card is destined to healthcare professionals for the confidential reporting of adverse drug reactions and this directly to the BCPH.

Après l’arrêté royal (AR) du 21.01.2009 relatif aux dispositifs médicaux implantables actifs, c’est au tour de l’AR du 17.03.2009 concernant les dispositifs médicaux d’être publié au moniteur belge ce vendredi 27.03.2009.

Following a decision of the Bristol-Myers Squibb Group, its Belgian subsidiary has asked the Federal Agency for Medicines and Health Products (FAMHP) to remove the MA for Corgard (nadolol). Corgard was the only drug containing nadolol approved in Belgium and can no longer be marketed in our country. This drug is still approved and marketed in other European countries. The removal of the MA for Corgard in Belgium, allows the Belgian pharmacists to import a drug containing nadolol in accordance with Article 105 of the Royal Decree of 14/12/2006 on medicinal products for human and veterinary use.

After a period of unavailability, the vaccine against Newcastle disease for pigeons, caused by avian paramyxovirus, will soon be available again.

The first meeting of the two chambers (one for products for human use and one for veterinary products) of the recently established Joint Commission took place on 17th February. This Commission is responsible for giving advice on the status of products for which there is some doubt as to the legislation to which they belong: is it a drug, a food product, a cosmetic, a medical device or a biocide? The final decision is taken by the Minister or his representative based on the advice of this Commission.

The European Medicines Agency (EMEA) has reviewed the available information on the two cases of status epilepticus with myoclonus reported in two girls vaccinated with the cervical cancer vaccine Gardasil.. The Committee for Medicinal Products for Human Use (CHMP) of the EMEA considers that the cases are unlikely to be related to vaccination with Gardasil. The CHMP is recommending that vaccination with Gardasil should continue in accordance with national vaccination programmes in Member States. Around three million girls in Europe have been vaccinated with this vaccine since it was first authorised.

European Medicines Agency (EMEA) recommends adding a contraindication to the summary of product characteristics and public information leaflet for aliskiren (Rasilez only is marketed in Belgium). Rasilez and any aliskiren-containing medicine must not be used in patients who have experienced angioedema when taking aliskiren in the past. Moreover, patients who develop signs of angioedema should stop treatment and seek medical attention.

The European Medicines Agency (EMEA) recommends the suspension of the European marketing authorization for Raptiva (efalizumab) from Serono because of safety concerns including the occurrence of progressive multifocal leukoencephalopathy in patients with psoriasis taking the medicine. RAPTIVA is not marketed in Belgium.