News FAMHP

Tc-99m is a radioisotope used in nuclear medicine for diagnosing many diseases. The majority of reactors producing mainly Mo-99 parent-isotope of Tc-99m, have been shut down for maintenance or due to technical problems. The two reactors that are still active are fully utilized. However, the amount of Tc-99m is not currently sufficient to meet all needs. Priorities have been defined.

Since the founding in 1976 of its Belgian Centre for Pharmacovigilance (CBPH), the Federal Agency for Medicines and Health Products (FAMHP), which is the competent authority regarding medicines, received more than 50,000 notifications, mainly serious adverse effects, from health care providers and the pharmaceutical industry (legal requirement since 1995). On its own initiative, Test-Achats created in 2006 a contact point for patients to report adverse reactions and other problems concerning medicines. In 2007 the FAMHP and Test-Achats concluded a collaboration agreement for the exchange of information on adverse events reported by the patients.

The Federal Agency for Medicines and Health Products (FAMHP) announces the availability of its electronic newsletter "VIG-NEWS" for the attention of health professionals. The VIG-NEWS is a selection of recent news of pharmacovigilance from different sources.

L’Agence Fédérale des Médicaments et des Produits de Santé (AFMPS) annonce la mise à disposition de sa newsletter électronique « VIG-NEWS » à l’attention des professionnels de la santé. Le VIG-NEWS est une sélection de communiqués récents de pharmacovigilance émanant de différentes sources.

The Federal Agency for Medicines and Health Products (FAMHP) and the Federal Public Service Health, Food Chain Safety and Environment (FPS Health) have noticed that more and more so-called « electronic » cigarettes, cigars and pipes are available on the market. The FAMHP and the FPS Health wish to, once again, warn people about the potential danger of this type of electronic device and the problems they can cause.

The EU's Better Regulation policy aims notably at simplifying and improving existing regulation. In this context, the “e-submission guidelines" concerning the electronic submission of dossiers for variation of marketing authorization of medicines for human use has been updated. The date of implementation of this new version has been set at 01.06.2010.

The FAMHP would like to bring to the attention of the Marketing Authorisation (MA) or registration holders of medicines the publication of a new version of the document concerning the application of measures relating to the sunset clause in Belgium for medicinal products authorised at the national level. This document outlines the basic rules of the sunset clause and provides all the information on exemptions.

In view of the incidents reported with the use of breast implants manufactured by the company PIP in France, the « Agence Française de Sécurité Sanitaire des Produits de Santé » (AFSSAPS) conducted an inspection. This has highlighted the use in the manufacture of these implants of a silicone gel different from the one approved. As a precaution, the FAMHP, like the AFSSAPS, asked distributors of these implants, pharmacists, physicians and persons who use them, to stop the distribution, delivery, use and export, waiting for the results of controls carried out by the AFSSAPS.

The FAMHP in its statement this Wednesday, 24th March reported the opinion of the European Medicines Agency (EMA) that the presence of DNA of a non-pathogenic strain in batches of the oral vaccine Rotarix, does not present a public health threat. The Committee for Medicinal Products for Human Use (CHMP) of the EMA, at its extraordinary meeting on 25th March, based on the available data, confirmed that this vaccine is safe and may therefore continue to be used as before.

The European Medicines Agency (EMA) has been informed by the manufacturer of Rotarix, GlaxoSmithKline Biologicals, about the unexpected presence of DNA of a non-disease causing viral strain in batches of this oral vaccine used to prevent gastro-enteritis due to rotavirus infection. The Committee for Medicinal Products for Human Use (CHMP) of EMA, after evaluation of available information, concluded that the presence of this DNA does not present a public health threat and that no action should be undertaken at this point. However, the CHMP has asked the manufacturer to provide additional information.