News FAMHP

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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The current postbox address of the FAMHP is no longer applicable.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.

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