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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.

Recommendations for suppliers of prescription software about the order of presentation and selection of medicinal products and non-medicinal products

The FAMHP and the NIHDI wish to remind prescription software suppliers of a number of homologation requirements for the order of presentation and selection of medicinal products and non-medicinal products.

End of the validation procedure for SARS-CoV-2 antigen self-tests

The validation procedure for SARS-CoV-2 antigen self-tests with a CE-marking ceased to apply since 23 January 2023. The associated list of recommended SARS-CoV-2 antigen self-tests with a CE-marking is therefore no longer available.

Point of contact at authorisation holders for the supply and availability of medicinal products

The FAMHP reminds marketing authorisation holders for medicinal products for human use to register a single point of contact (i-SPOC) for the supply and availability of medicinal products through the IRIS platform of the EMA.

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