News FAMHP

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The FAMHP launches the Medicinal Product Management database: updating data in existing medicinal product databases temporarily not possible

On 4th of July 2022, the FAMHP launches the Medicinal Product Management database, a new internal database for medicinal products. Due to the launch, it will be temporarily impossible to update the data in the existing medicinal product databases.

PRAC June 2022 –Update of COVID-19 vaccins and new safety information for Xalkori.

During its June 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is continuing its assessment of cases of heavy menstrual bleeding (heavy periods) with the COVID-19 mRNA vaccines and the PRAC finds no link between mRNA COVID-19 vaccines and absence of menstruation. The PRAC also discussed a direct healthcare professional communication (DHPC) containing important safety information for Xalkori.

Request to marketing authorisation holders to send the approved version of the risk management plan

The Vigilance Division of the FAMHP requests marketing authorisation holders to send the approved version of the risk management plan for medicinal products for human use with a national marketing authorisation.

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: the Belgian guideline for the management of clinical trials during the coronavirus pandemic no longer applies

Due to the ending of the epidemiological emergency situation on 10 March 2022, the Belgian guideline to assist sponsors in the management of clinical trials during the coronavirus pandemic no longer applies. From now on, the rules in force will be applied and any deviation must be requested by providing a clear description of the situation.

PRAC May 2022 – Discussion regarding a direct healthcare professional communication (DHPC) containing important information for Defitelio

During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) discussed a direct healthcare professional communication (DHPC) containing important information for Defitelio.

Call for tender by the European Commission: reservation of manufacturing capacities and priority right to manufacture vaccines

The European Commission has launched a call for tender to conclude single (consortium) framework contracts to reserve manufacturing capacities and obtain a priority right to manufacture vaccines in case of a future public health emergency. The project is called EU FAB.

Symposium on vaccines on 10 and 12 May 2022: the importance of lifelong immunisation, lessons from the COVID-19 pandemic, and future prospects

The FAMHP and pharma.be are organising two half-day symposia on vaccines on 10 and 12 May 2022. The first day will focus on the FAMHP and the VACCINES spearhead. This will cover topics such as clinical trials, regulatory activities, pharmacovigilance, and inspections. The second day will focus on effective vaccination, before closely examining the way vaccination campaigns are organised and implemented, vaccine hesitancy, and data collection. You can register now.

Impact of war in Ukraine on clinical trials

The current war in Ukraine has had a huge impact on clinical trials in Ukraine, Russia and Belarus. Due to the war, a large number of patients in these countries participating in clinical trials are no longer able to participate. There are also problems with the supply of medicinal products and other supplies for conducting clinical trials. The relevant authorities in countries within the European Union are making every effort to ensure the continuity of treatment for patients in ongoing clinical trials by providing the option to continue their treatment at trial sites abroad.

PRAC April 2022 – No causal association found between the COVID-19 vaccines Comirnaty and Spikevax and autoimmune hepatitis

During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that available evidence does not support a causal link between COVID-19 vaccines Comirnaty and Spikevax and very rare cases of autoimmune hepatitis.

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