When reporting side effects in the product information, one can now refer to the FAMHP’s post box address.
Marketing authorization (MA) holders can now also use the FAMHP’s post box address in product information
The FAMHP is updating the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials in Belgium.
Implants and certain invasive medical devices: as of June 3, 2019, the FAMHP takes over the RIZIV notification database.
Every company selling implants and certain invasive medical devices in Belgium must report the data for these in a notification database. The notification of these medical devices applies as a condition for reimbursement of the obligatory insurance for health care. From June 3, 2019 the notification of these medical devices in the database will occur via a new online application at the Federal Agency for Medicines and Health Products (FAMHP).
Give your opinion on a clinical trial with a genetically modified medicinal product in Pediatric Subjects With Advanced Noncentral Nervous System Tumors That are Amenable to Direct Injection.
The FPS Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified medicinal product Talimogene Laherparepvec from the company Amgen. The purpose of this trial is to determine the safety and efficacy of talimogene laherparepvec in pediatric subjects with advanced non-central nervous system (CNS) tumors that are amenable to direct injection. The public consultation runs from 24 March to 24 April 2019 inclusive.
The FAMHP is updating the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials in Belgium, with the introduction of a new option for sponsors willing to participate : the VHP plus.
The FPS Public Health and the FAMHP invite you to participate in the public consultation on two clinical trials with the genetically modified medicinal product AAV5-hFVIII-SQ (BMN 270) against hemophilia A. The public consultation runs from 27 February 2019 to 29 March 2019 inclusive.
Notifications about anti-tampering device (ATD) or devices to prevent tampering on packaging of existing drugs that do not fall under the Falsified Medicines Directive
Within the framework of the Falsified Medicines Directive, FMD) which is effective as of February 9, 2019, all drug packaging falling under this legislation must be equipped with an anti-tampering device (ATD). Packaging of these drugs not subject to this obligation may also have an ATD. The marketing authorization holder must submit a request for this to the FAMHP.