The current war in Ukraine has had a huge impact on clinical trials in Ukraine, Russia and Belarus. Due to the war, a large number of patients in these countries participating in clinical trials are no longer able to participate. There are also problems with the supply of medicinal products and other supplies for conducting clinical trials. The relevant authorities in countries within the European Union are making every effort to ensure the continuity of treatment for patients in ongoing clinical trials by providing the option to continue their treatment at trial sites abroad.
Over the past few weeks, more than three hundred thousand citizens have obtained iodine tablets from their pharmacies as a result of the conflict in Ukraine. The FAMHP has listed a few recommendations.
The FAMHP encourages non-profit organisations and academia to apply for the pilot project for the repurposing of authorised medicines
The FAMHP takes part in the European pilot project for the repurposing of medicines to support non-profit organisations and academia. The project was launched by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA).
On 28 January 2022, the European Regulation on medicinal products for veterinary use has entered into force. Among other things, this implies that veterinarians have the obligation to use a new model format for veterinary prescriptions. These changes will take place in several phases.
As of 28 January 2022, Regulation 2019/6 became effective. From that moment onwards, European Member States must comply with all rules from this regulation.
Register now for the online information session on the new European veterinary medicines legislation on 15 October 2021
On 15 October 2021, the FAMHP is organising an online information session on the European Regulation 2019/6 regarding veterinary medicines. The information session is intended for people working in the Belgian pharmaceutical industry.
In its new advice the Joint Commission states that nicotine pouches are no longer considered to be a medicinal product. When used normally, the usual doses (around 10 mg) do not pose a risk of poisoning. However, there are some recommendations for manufacturers. These concern the nicotine yield and the maximum daily dose, the use by children and therapeutic claims.
Coronavirus: new version of Belgian directive for management of clinical trials during coronavirus pandemic
A new version of the national directive is available to supplement the European guidelines (v3) for the management of clinical trials during the coronavirus pandemic.
Unavailability of Visudyne 15 mg (powder for solution for infusion) : recommendations for (hospital) pharmacists and physicians-specialists
The medicinal product Visudyne 15 mg, used in ophthalmology, has been unavailable in Belgium since 30 May 2020. The FAMHP is therefore making recommendations.
The medicinal product Bleomycine Sanofi 15,000 IU, used in the treatment of certain cancers (testis, throat, mouth, Hodgkin's disease and non-Hodgkin's lymphoma), is currently in limited availability. While waiting for a sufficient quantity of the medicinal product to return to the market, the FAMHP experts recall the recommendations for the rational use of stocks of Bleomycine Sanofi 15,000 IU that may still be available.