From 31 January 2025, only the Clinical Trials Regulation (EU) 536/2014 and its delegated acts will apply, as stipulated in Article 98 of the regulation. The FAMHP calls on sponsors to transfer clinical trials to Regulation 536/2014 as soon as possible.
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Deadlines for the submission of dossiers during the end-of-year period
During the end-of-year period, the FAMHP will be closed from Wednesday 25 December 2024 to Wednesday 1 January 2025. Deadlines have been set for the submission of different types of dossiers.
The FAMHP once again takes part in the global campaign for safer use of medicines
Today sees the start of the ninth edition of #MedSafetyWeek, a global campaign running from 4 to 10 November 2024, bringing together 107 organisations from 94 countries. This year's theme is the importance of using medicines correctly in order to prevent adverse effects and to report them if they occur.
PRAC October 2024 – The EMA started safety review of medicines containing finasteride and dutasteride
During its October 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency started safety review of medicines containing finasteride and dutasteride, to assess data related to suicidal thoughts and behaviours. Furthermore the PRAC formulated new safety information intended to healthcare professionals (DHPC) regarding a risk of medication errors due to change of dosing syringe for Keppra oral solution 150ml 100mg (levetiracetam)/1ml (with dosing syringe of 3 ml).
Import of medicinal products by wholesalers in case of special needs: publication of notification forms
On 1 November 2024, the new Article 105/1 came into force. Wholesalers will be allowed to distribute medicinal products that are not authorised in Belgium in our country if they meet a special need in Belgium due to a critical unavailability. The notification forms are now available.
Give your opinion on a genetically modified vaccine for the treatment of hepatitis B
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified vaccine LAV-YF17D/HBc (AVX70371) for the treatment of hepatitis B. The public consultation runs from 30 October 2024 to 29 November 2024.
Publication of Article 105/1: import of medicinal products by wholesalers in case of special needs
Wholesalers will be allowed to distribute medicinal products that are not authorised in Belgium in our country if they meet a special need in Belgium due to a critical unavailability, as determined by the Federal Agency for Medicines and Health Products (FAMHP).
Flash VIG-news: European review of finasteride and dutasteride-based medicinal products
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is going to evaluate data relating to suicidal ideation and behaviour.
Vaccine against epizootic haemorrhagic disease virus: authorisation for use in Belgium
The FAMHP authorises the use of the immunological veterinary medicinal product Hepizovac (suspension for injection from the company CZ Vaccines S.A.U.) intended for cattle.
PRAC September 2024 – Recommendation for metamizole and to minimise the risk associated with medroxyprogesterone acetate
The PRAC recommends measures to minimise serious outcomes of known side effect with the painkiller metamizole and formulated new recommendations to minimise the risk of meningioma with medicines containing medroxyprogesterone acetate. During its September 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended measures to minimise serious outcomes of known side effect with painkiller metamizole and formulated new recommendations to minimise the risk of meningioma with medicines containing medroxyprogesterone acetate.