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Marketing authorisation holders: mandatory update of contact details in product information for reporting adverse reactions to the FAMHP

The current postbox address of the FAMHP is no longer applicable. The contact details for reporting adverse reactions to the FAMHP should be changed by marketing authorisation holders in the product information of medicinal products for human use as soon as possible.

Give your opinion on a genetically modified medicine for the treatment of hemophilia B

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine PF-06838435 for the treatment of hemophilia B. The public consultation runs from 28 February 2024 to 28 March 2024.

Give your opinion on a genetically modified medicine for the treatment of limb girdle muscular dystrophy

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine SRP-9003 for the treatment of limb girdle muscular dystrophy. The public consultation runs from 14 February 2024 to 14 March 2024.

Reminder - Deadline for registration of annual sales volume data for veterinary medicinal products

Marketing authorisation holders have until 29 February 2024 to submit annual sales volume data for veterinary medicinal products for 2023.

Update of the Belgian regulatory guidance on the use of GMOs in clinical trials

The FAMHP and Sciensano are making available a Belgian regulatory guidance on the use of genetically modified organisms in clinical trials.

Give your opinion on a genetically modified vaccine for the prevention of rabies

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified vaccine PLLAV-YF17D/RabG for the prevention of rabies. The public consultation runs from 20 December 2023 to 19 January 2024.

Deadline for registration of annual sales volume data for veterinary medical products

Marketing authorisation holders have until the end of February 2024 to submit annual sales volume data for veterinary medical products for 2023.

Hugues Malonne is the FAMHP's new Chief Executive Officer

Hugues Malonne appointed new FAMHP Chief Executive Officer by the federal government

New system for financing the surveillance of the medical devices market

A new system for financing the surveillance of the medical devices market applies from 2023. This system aims to make fees fairer between the different stakeholders in the sector, as each one must pay a fee that is consistent with its turnover and with the level of risk involved in its activity and in the workload it represents for the FAMHP.

Give your opinion on a genetically modified medicinal product for the treatment of the eye disorder geographic atrophy

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicinal product JNJ-81201887 (AAVCAGsCD59) for the treatment of geographic atrophy secondary to age-related macular degeneration. The public consultation runs from 22 March 2023 to 21 April 2023.

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