Sign up for our webinar on the new clinical trials regulation (CTR) on 23 September 2021. Register now at CTRpilot@fagg-afmps.be.
You will learn more about the implementation of the CTR and the CTR pilot project. 

 

 

News

Register now for the online information session on the new European veterinary medicines legislation on 15 October 2021

On 15 October 2021, the FAMHP is organising an online information session on the European Regulation 2019/6 regarding veterinary medicines. The information session is intended for people working in the Belgian pharmaceutical industry.

Nicotine pouches are no longer considered to be a medicinal product

In its new advice the Joint Commission states that nicotine pouches are no longer considered to be a medicinal product. When used normally, the usual doses (around 10 mg) do not pose a risk of poisoning. However, there are some recommendations for manufacturers. These concern the nicotine yield and the maximum daily dose, the use by children and therapeutic claims.

IUB™ Ballerine (intrauterine device)®: temporary suspension of CE marking

The FAMHP has been informed of the temporary suspension of the CE marking (proof of conformity) of the IUB™ Ballerine® (intrauterine device) from the manufacturer Ocon Medical ltd as of 16 July 2021, due to the unsatisfactory results of the assessment of the device. Taking into account this suspension and in line with the monitoring of vigilance data, there are no arguments to date to justify the recall of the devices still on the market.

PRAC August 2021 – Recommendation and review of safety issues related to COVID-19 vaccines

During its August 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended updating the product information of COVID-19 Vaccine Janssen. Furthermore, the PRAC continues to closely review reports of Guillain-Barré syndrome with Vaxzevria and discussed other safety issues occurring after vaccination against COVID-19.