During its November 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has made un update on COVID-19 vaccines and concluded a safety signal for Imbruvica.
The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified vaccine VSV-GP128 to treat colorectal cancer. The public consultation will run from 1 November 2021 to 1 December 2021.
PRAC October 2021 – Nomegestrol containing products and chlormadinone containing products and update on COVID-19 vaccines
During its October 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a review of meningioma risk with nomegestrol- and chlormadinone-containing medicines. The PRAC also has reviewed data on venous thromboembolism and immune thrombocytopenia with COVID-19 vaccines.
Veterinarian? Register now for the online information session on the new European legislation on veterinary medicines on 22 October 2021
On 22 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 veterinarians and describes the impact and practical implementation in Belgium.
From 1 October 2021, the FAMHP uses a new invoicing method for applications for national scientific-technical advice of types I, II and III that are treated by the National Innovation Office and Scientific-Technical Advice Unit.
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.
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.
Coronavirus: new version of Belgian directive for management of clinical trials during coronavirus pandemic
A new version of the national directive is available to supplement the European guidelines (v3) for the management of clinical trials during the coronavirus pandemic.
Warning against online sales of counterfeit medicine Seresto®, an anti-flea and anti-tick collar for cats and dogs
A counterfeit version of the medicine Seresto® collar for cats and dogs is being sold through Dutch online stores. The FAMHP warns against pet health hazards.
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.