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New nomenclature for incidents with medical devices

From January 2020 there is a new nomenclature applicable for manufacturers reporting an incident with a medical product to the FAMHP. The FAMHP advises manufacturers of medical devices to already change their internal codes to the new nomenclature codes.

11 and 17 December 2019: final date for submitting dossiers during Christmas holidays

During the Christmas holidays, the FAMHP will be closed from Wednesday 25 December 2019 until Wednesday 1 January 2020 included.

As of November 1, 2019, the duration of validity of a medical prescription will be a standard three months

The pharmacist can now only deliver medications up to three months after the prescription date, with the exception of when the prescriber indicates a date of delivery. For reimbursed medications, the reimbursement date is also three months from the date on which the prescriber issued the prescription.

Marketing authorization (MA) holders can now also use the FAMHP’s post box address in product information

When reporting side effects in the product information, one can now refer to the FAMHP’s post box address.

Update on the new Clinical Trial Regulation pilot project

The FAMHP is updating the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials in Belgium.

New Company Code requires marketing authorisation holders to amend their documents

The new Belgian Company Code, which concerns companies and associations, and which came into force on 1 May 2019, refers to only 4 corporate forms. This will have implications for some authorisations and registrations in the sense that holders thereof are now required to amend their documents.

Amendments as a result of the new financing law of 2019

On 20 May 2019, the law changing provisions regarding providing scientific and technical advice by the Federal Agency for Medicines and Health Products and regarding the financing of the Federal Agency for Medicines and Health Products (financing law of 2019) has been published in the Belgian Official Gazette. The new law changes a number of aspects of the function and financing of the Federal Agency for Medicines and Health Products (FAMHP).

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).

Brexit: application of European drug precursors legislation

When the United Kingdom (UK) leaves the European Union (EU) this will have consequences for the trade in drug precursors. Different scenarios are possible.

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.

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