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The Royal Decree of 21/01/2009 (“Moniteur belge” 30/01/2009) giving instructions for pharmacists, replaces the Royal Decree of 31/05/1885 and it introduces new regulations for pharmacists in public pharmacies. These aim to improve the management of pharmaceutical work, the responsibility of pharmacists, the accessibility of pharmacies, the delivery of medicines and they also specify good officinal practice. Article 29 of this decree also regulates the sale of medicines on the internet. In this context Circular 536 draws the attention of pharmacists in public pharmacies to a few key points related to this issue.

The Royal Decree (RD) of 21.01.2009 (“Moniteur Belge”, 30.01.2009) amending the Royal Decree of 15.07.1997 relating to active implantable medical devices transposes into Belgian law the Directive 2007/47/EC which refines, improves and completes some rules.

The European Medicines Agency (EMEA) has recommended that Fareston (toremifene) should not be used in patients at risk of prolonged QT intervals or other heart problems.

The European Medicines Agency (EMEA) has concluded that methylphenidate-containing medicines remain suitable for the treatment of children aged six years or older and adolescents with attention deficit/hyperactivity disorder (ADHD). It has also recommended that the product information be made consistent across the European Union (EU) so that all patients, carers and prescribers have the same information for safer and more appropriate use of these medicines.

The Federal Agency for Medicines and Health Products (FAMHP) celebrates two years of existence with the launch of its new and first website but also with the introduction of its new structure and the appointment of the three General Directors.

The Federal Agency for Medicines and Health Products (FAMHP) draws attention to the release of the European Medicines Agency (EMEA) recommending priority access for children during the Myozyme expected supply shortage.

Following the indexing of the fees of payments due for the missions of the Federal Agency of Medicines and Health Products (FAMHP), the tables have been adapted and applied since 01/01/2009.

The FAMHP wrote a circular concerning the pharmacovigilance inspections for the attention of holders of marketing authorization of medicines for human and veterinary use and for the persons responsible for pharmacovigilance

Newsletter @ctua