On 1 January 2025, the Royal Decree of 22 September 2024 on advertising of medicinal products for veterinary use will come into force. That Decree describes the mandatory notification procedure prior to the distribution of any advertisement for a medicinal product for veterinary use to the general public.
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Call to professionals responsible for materiovigilance: take part in European Commission survey on electronic instructions for use
The European Commission is considering allowing the use of electronic instructions for use for all devices for professional use. The Commission is therefore launching a survey for healthcare professionals.
Improving the availability of in vitro diagnostics: European measures
New measures published in the European Union’s Official Journal come into effect to improve the availability of in vitro diagnostics, for patients and healthcare providers.
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.
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.
Call for Belgian laboratories to apply to become the European Union reference laboratory for in vitro diagnostic medical devices
The European Commission has launched a call for laboratories of Member States to apply to become European Union reference laboratories (EURLs) for in vitro diagnostic (IVD) medical devices. The possible designation of such EURLs is provided for in article 100 of the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
Update on the safety notifications about CPAP, BiPAP and ventilator devices manufactured by Philips
Extensive analyses of Philips' CPAP, BiPAP and ventilator devices have not revealed toxicologically relevant levels of volatile organic compounds. Nevertheless, no risk can be excluded at this time: patients are advised to consult their physician about the further course of their treatment.
Coronavirus: EMA gives positive opinion for Moderna vaccine
The European Medicines Agency (EMA) issued a positive opinion for “COVID-19 Vaccine Moderna”, making it the second COVID-19 vaccine to be authorised for marketing in the European Union. This recommendation still has to be confirmed by the European Commission. Belgium has purchased the vaccine and will use it in its vaccination campaign.
Coronavirus: the FAMHP again calls for rational use of oxygen
Due to the second wave of the COVID-19 pandemic, there is an increased need for oxygen in Belgium for patients with respiratory problems. The FAMHP asks all actors and users not to stockpile and return unused or empty material to the supplier as soon as possible.
Central traceability register: the traceability of certain implants to become compulsory
From 1 May 2021, notification of the insertion or removal of implants will become compulsory for the implants listed in the annex to the Royal Decree of 27.09.2020 relating to the Central Traceability Register (RCT in French). This notification was already possible (but not compulsory) for all implants since 2014.