competent for all activities following approval of the first marketing authorisation for a medicine or health product
In 2022, we observed that the statutory deadline for concluding IA/IB variations of mutual recognition procedures, with or without a minor impact on the official documents, once again could not be met as effectively. This year once again and in total, fewer case files concerning variations and renewals of marketing authorisations for medicinal products for human use have been concluded than were received. The contact centre answered fewer questions in 2022 than in 2021.
The number of reports of adverse events involving medicinal products for human use is lower than in 2021. In that year, we observed the effect of the national vaccination campaign to combat COVID-19. The number of reports is still greater than in 2020 (before the COVID-19 crisis).
In 2022, Belgium participated in a European working group on the signal management process and the following up of signals in accordance with Regulation (EU) 2019/6 on veterinary medicinal products.
In the context of pharmacovigilance applied to veterinary medicinal products, the signal management process has become “the gold standard” with regard to the following up of the benefits-risks evaluation. The signal management process can actually lead to a recommendation that certain measures be taken.
The number of reports of serious incidents increased in 2022 by 10 % compared to 2021. This confirms the rising trend observed in preceding years.
In 2022, we observed a slight decrease in the number of reports of serious adverse events and of incidents involving cells and tissues.
The number of reports of incidents and serious adverse events involving blood and labile blood components is increasing. In 2022, the FAMHP received the highest number of reports since the reporting system began in 2006.
(manufacturers, legal representatives, distributors, importers) were registered via the online registration system
Since 2022, we have observed a significant increase in the number of case files being submitted to the new internal advisory body known as the “advisory board”, which has replaced the former Evaluation Committee for Medical Aids.
The advisory body handles various types of case files, such as applications for derogation from the CE marking; decisions regarding the status, classification and validation of clinical studies; the need to conduct a product recall. Various divisions of the FAMHP work together on the advisory body.
In 2022, a total of 26 meetings took place, during which various case files were handled.
Follow us
