Once it is authorised on the market, a chemical medicinal product may be subject to laboratory testing. The aim is to check the product’s quality. It is tested whether the medicinal product complies with the specifications for, for instance, the active ingredient content as registered in the marketing authorization application or in the legal requirements of the European Pharmacopoeia for pharmacy compounded medicines. The laboratory testing takes place at RIVM.
RIVM communicates the results to the enforcement authority, which is the Health and Youth Inspectorate (for human medicines), and the Ministry of Agriculture, Fisheries, Food Security and Nature (for veterinary medicines).
Testing of medicinal products is carried out based on:
- signals or doubts about the product’s quality
- Associated risks of medicinal products selected through the preferential policy (not applicable to veterinary medicinal products)
- The Centrally Authorised Products programme of the EMA
- The Market Surveillance Study programme of the EDQM (not applicable to veterinary medicines)
Medicinal products are usually tested for:
- content and purity of the active substance(s)
- and, where relevant, specific characteristics of the dosage form (such as a tablet or injection fluid).
In addition to these products that RIVM is investigating, pharmaceuticals that are on the market in the Netherlands can also be tested by other laboratories in the OMCL network.
This takes place within the framework of the MRP/DCP marketing testing scheme.
More than 95 percent of the human medicines tested have met the required quality standards. About 5 percent have out-of-specification (OOS) defects. Tables 1 and 2 provide an overview of the total number of medicinal products examined in relation to the number of abnormalities.
Table 1 Overview of Human Medicine
Year | Total products examined | OOS results (number (%)) |
|---|---|---|
2020 | 522 | 4 (0,8%) |
2021 | 663 | 7 (1,3%) |
2022 | 722 | 17 (2,4%) |
2023 | 803 | 37 (4,6%) |
Table 2 - Overview of Veterinary Medicines tested in within the OMCL network
Year | Total products examined | OOS results (number (%)) |
|---|---|---|
2020 | 107 | 1 (0,9%) |
2021 | 158 | 4 (2,5%) |
2022 | 156 | 2 (1,3%0 |
2023 | 182 | 11 (6,0%) |
2024 | 212 | 6 (2,8%) |