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May employees of companies making, importing or distributing medical devices be present in the surgical area? Yes, but only under certain conditions.

L’Amérique du Nord connait depuis plusieurs années une « épidémie » d’abus, de surdosages et de décès liés aux opioïdes. Dans une moindre mesure, ces dernières années l’utilisation d’opioïdes en Europe a fortement augmenté, entre autres pour faire face au syndrome de la douleur chronique. Bien que s’inscrivant dans le cadre de l’amélioration de la prise en charge de la douleur, l’utilisation accrue d’opioïdes est remise en question au vu des risques associés à leur abus. L’accent est donc mis sur la prévention de la dépendance et des abus, et sur l’importance de l’usage rationnel des opioïdes.

The European Medicines Agency (EMA) is performing further research after a recombinant strain containing two living attenuated Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) vaccines was identified in Denmark. The recombinant strain was associated with clinical symptoms of PRRS, such as reduced fertility in sows, increase in the number of rejections, increased in piglet mortality, reduced appetite and respiratory conditions in young pigs.

Quality defects in medicinal products can impact patients’ health or make it difficult for healthcare professionals to administer them. Quality defects can be reported via the FAMHP website.

Based on the evolution of the pilot project for the new Clinical Trial Regulation, the FAMHP made an update on the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials.

During the meeting of 28- 31 October 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) implemented measures to minimise risk of serious side effects with Lemtrada. Furthermore, the PRAC recommended Xeljanz to be used with caution for all patients at high risk of blood clots.

The FAMHP asked more than 12,000 francophone university students about the use of stimulant drugs. 5% of them said to use stimulant medicines for non-medical use, in order to study better.

The European Medicines Agency (EMA) and the competent medicine authorities of the European member states, including the FAMHP, have been notified that in a small number of diabetes medicines based on metformin outside of the European Union, a nitrosamine contamination (NDMA, N-nitrosodimethylamine) has been detected. Currently, analyses are being performed on the medicines within the European Union.

As of 1 January 2020, medicines with only one active ingredient can be sold for treating coughs and colds.

The FAMHP launches PharmaStatus, the new online application that collects information about the availability of medicines in Belgium and makes it public. Current information will help patients, doctors, pharmacists and the pharmaceutical industry to limit the impact of unavailable medicines.