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Destruction

Licence or registration holders of category 1 and 2 registered substances should contact FPS Finance - Customs and Excise, Precursors cell at da.investigation.precursors@minfin.fed.be for destruction of raw materials/ semi-finished products/ rejected batches.

There are no special requirements for the other categories (3 and 4). Medicines must be destroyed in accordance with the applicable waste legislation.

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Questions and answers about the online application for narcotic drugs order forms narcoreg.be

Questions and answers about the online application for narcotic drugs order forms narcoreg.be
Specific questions and answers for pharmacists
Specific questions and answers related to veterinary use

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

25/10/2023

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

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Sparsentan

Active substance	Sparsentan
Holder	Bionical Emas T/A Bionical Limited (on behalf of Vifor (International)AG)
Status	Running
Indication	Treatment in adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion >1g/day
Public documents	Read more about Sparsentan Deadlines for the submission of dossiers during the end-of-year period 19/10/2023 During the end-of-year period, the FAMHP will be closed from Monday 25 December 2023 to Monday 1 January 2024. Deadlines have been set for the submission of different types of dossiers. Read more about Deadlines for the submission of dossiers during the end-of-year period Health institutions and healthcare professionals Read more about Health institutions and healthcare professionals Reprocessing single-use medical devices General information Common specifications Notification on the FAMHP web portal Information to be provided with the reprocessed device Vigilance 1. General information Regulation 2017/745 on medical devices and the Law of 22 December 2020 on medical devices provides for the possibility for health institutions to reprocess single-use devices for further use. Read more about Reprocessing single-use medical devices Devices manufactured and used only within health institutions ('in-house' devices) General information Conditions for the manufacture and use of in-house devices Publication of the declaration of manufacture for in-house devices Vigilance Guidance documents and Q&A Read more about Devices manufactured and used only within health institutions ('in-house' devices) Data Tracking System: new application for the effective management of marketing authorisation and vigilance dossiers 16/10/2023 On 16 October 2023, the Data Tracking System (DTS) dossier will go live within the FAMHP. This application replaces four MeSeA applications. DTS provides additional functionalities that facilitate the effective management of dossiers in the context of marketing authorisation and vigilance. Read more about Data Tracking System: new application for the effective management of marketing authorisation and vigilance dossiers PRAC October 2023 – New safety information for Omega-3-acid ethyl esters 12/10/2023 During the October 2023 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency, recommends an update to the product information for medicines containing omega-3-acid ethyl esters, to inform healthcare professionals and patients of the risk of atrial fibrillation. Read more about PRAC October 2023 – New safety information for Omega-3-acid ethyl esters Go to first page Go to previous page … Go to page 4 Go to page 5 Go to page 6 Go to page 7 Current page 8 Go to page 9 Go to page 10 Go to page 11 Go to page 12 … Go to next page Go to last page Subscribe to © 2016 - FAMHP Privacy Disclaimer