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Updated guidelines for the labelling and packaging of medicinal products for human use

Marketing authorisation holders of a medicinal product for human use are required to follow certain guidelines for the labelling and packaging of medicinal products. These guidelines have recently been updated.

Evaluation of European regulations on medical devices: the European Commission launches a public consultation

The European Commission has launched a public consultation to assess Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) on medical devices and in vitro diagnostic medical devices. The aim of this initiative is to gather stakeholders' opinions on the effectiveness of the current regulations and to identify any shortcomings.

Applications for revisions to the register of pharmacies can from now on be done online

In Belgium, any authorisation for the opening, merger, transfer, temporary and permanent closure of a pharmacy open to the public must be registered in the FAMHP's register of pharmacies. In addition, any change, such as a different pharmacist in charge, an additional cadastral plot or the acquisition of a pharmacy, must be reported to the FAMHP. From now on, the FAMHP's new online application can be used for this purpose.

Notification procedure for advertising of medicinal products for veterinary use to the public

On 1 January 2025, the Royal Decree of 22 September 2024 on advertising of medicinal products for veterinary use will come into force. That Decree describes the mandatory notification procedure prior to the distribution of any advertisement for a medicinal product for veterinary use to the general public.

Important call to clinical trial sponsors: transfer clinical trials to the CTR as soon as possible

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.

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.

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).

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.

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.

Call to professionals responsible for materiovigilance: take part in European Commission survey on electronic instructions for use

The European Commission is considering allowing the use of electronic instructions for use for all devices for professional use. The Commission is therefore launching a survey for healthcare professionals.

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