competent for all inspection and control activities
The number of questions on the regulation of firms, human body material banks and blood establishments has increased. This is partly due to the recent proposal for a European regulation on quality and safety standards for substances of human origin intended for application to human beings. The Distribution Division inspection team supports the implementation of this regulation.
The royal decree of 16 January 2022 establishes the new regulations for the establishment and registration of pharmacies. The main objectives were administrative simplification and speeding up procedures. Since the royal decree became effective, we see that administrative simplification has reduced the number of registrations and increased the number of applications to establish a pharmacy.
Since the publication of the royal decree of 30 September 2020, the FAMHP is competent for the sterilisation of medical devices in hospitals. The first inspections of these sterilisation units took place in 2022.
Since the start of the COVID-19 crisis, the number of investigations into medical devices has decreased for the first time (from 562 to 243).
The number of inspections among manufacturers of medical devices has increased by 87 %.
The packages contained non-compliant medicines, medical devices and in vitro diagnostics.
In 2022, a large number of cases were handled concerning antiviral agents for the treatment of feline infectious peritonitis, an infectious peritonitis affecting cats that always ends fatally without treatment. It seems there is a lively trade in non-compliant (illegal) medicinal products of Chinese origin sold to cat owners at exorbitant profits.
Another novelty observed in 2022 is the international traffic of medicinal products that can be directly (tramadol) or indirectly (pregabalin) linked to an addiction problem.
In 2022, there was a large increase in foods containing pharmaceutically active substances. There was both an increase in the number of observations and in the diversity of foods containing such substances. These are mainly erectile stimulants and drugs used to lose weight. This trend started with alternative administration forms of sildenafil (in gel form) and has recently spread to coffee, tea, honey, jam, chocolate spread … without the substance being listed as an ingredient.