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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.

Modified invoicing for applications for national scientific-technical advice

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.

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.

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.

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.

End of submissions for initial CTR pilot files on 14 October 2021

The pilot project for the new Clinical Trial Regulation (CTR) will end when the CTR Regulation enters into force. All initial dossiers under the CTR pilot procedure must be submitted by 14 October 2021.

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