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.
Coronavirus: new version of Belgian directive for management of clinical trials during 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.
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.
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.
Updated guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP
A new version of the guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP is available.
Limited availability of RoActemra (Roche): recommendations for (hospital) pharmacists, general practitioners and physician specialists.
The stock of RoActemra, a medicinal product used for certain rheumatological and haematological disorders, is currently limited worldwide. The Federal Agency for Medicines and Health Products (FAMHP) therefore issues recommendations.
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 medicine PR006A to treat frontotemporal dementia with progranulin mutations (FTD-GRN). The public consultation will run from 28 July 2021 to 27 August 2021.
Unavailability of Visudyne 15 mg (powder for solution for infusion) : recommendations for (hospital) pharmacists and physicians-specialists
The medicinal product Visudyne 15 mg, used in ophthalmology, has been unavailable in Belgium since 30 May 2020. The FAMHP is therefore making recommendations.
Discontinuation of the telephone contact point of the Marketing Authorisation Division (variations and renewals)
The telephone contact point of the Marketing Authorisation Division (variations and renewals) will be discontinued as of Friday 16 July 2021. The division can still be contacted by email.