The American Food and Drug Administration (FDA) has recognised the FAMHP as its Belgian counterpart under the mutual recognition agreement (MRA) between the European Union and the United States.
Product recall of batches of Durex Natural Feeling Extra Lubricated and Durex Real Feeling latex-free polyisoprene condoms
The FAMHP would like to remind consumers and patients about a recall by Reckitt Benckiser of Durex Natural Feeling Extra Lubricated condoms and Durex Real Feeling latex-free polyisoprene condoms. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.
The FAMHP would like to relay safety information concerning two types of ear thermometer to consumers and patients. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.
Medical devices: autocontrol and administrative simplification. End of the transition period on 17th June 2018.
As a result of the changes in the legislation on medical devices, the FAMHP has set up a web portal in order to facilitate registration. The transition period ends on 17th June 2018. From then on, all the operators that fail to register will no longer be able to legally carry out their activities.
Following an alert from the United Kingdom's National Health Service (NHS), the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) analysed reports of incidents linked to the extraction of insulin from prefilled pens and cartridges for reusable pens with the aid of a syringe. This practice can increase the risk of medication error and lead to dysglycaemia. However, until today, only the package leaflets of certain insulins mentioned the possibility of such extraction.