Substandard and falsified medical products
Substandard medical products are authorised medical products that do not meet the relevant quality standards and/or specifications.
Falsified medical products are medicines that intentionally or fraudulently misrepresent their identity, composition or origin. These medicines are not authorised by the competent authorities where they are marketed, distributed or used.
The use of substandard or falsified medical products can be detrimental to health, and in the worst case, fatal.
Risks and causes
Consequences
What can you do?
BEFORE
- Only buy medical products from approved pharmacies or reliable, accredited websites.
- Are you looking to buy a medical product from a pharmacy or online retailer? First check to see if you can find the green EU logo for registered sellers. For more information on how to recognise a reliable online pharmacy, visit PharmaInfo.
- Do you have doubts about the quality or authenticity of a product? Ask your pharmacist or GP and do not use the product.
- Prescription medicines can only be purchased from your pharmacist.
DURING
- Report any side effects, incidents or adverse events related to medicines or health products to the Federal Agency for Medicines and Health Products (FAMHP).
AFTER
- Get informed and warn your friends and family about substandard or falsified medical products. This can help prevent further spread.
Impact and probability
The figures relating to probability and impact describe a scenario of substandard and falsified medical products/medicines on a extreme scale. The BNRA theoretically describes such a scenario as follows:
A large number of people use, or could use, substandard or falsified medicines.
- The side effects of these drugs can sometimes be dangerous, even fatal, as they are not controlled and often contain harmful or unauthorised ingredients.
- This increases the risk of exposure to dangerous chemicals and pathogens.
- These fraudulent products are marketed as substitutes for essential medicines. They may have reduced efficacy, thereby disrupting any ongoing treatment.
How should you interpret these results?
Within the BNRA, experts assessed three scenarios for each risk: considerable, major or extreme. On each page, you will find the results of the scenario with the highest score based on the combination of likelihood and impact. This does not mean that this scenario will occur or is the most likely. Read more here about how to correctly interpret the results.
Probability
Strong
Human impact
Weak
Societal impact
Weak
Environmental impact
No impact
Financial impact
Weak
What do the authorities do?
The Federal Agency for Medicines and Health Products (FAMHP) oversees the quality, safety and efficacy of medicines, from development to use.
The European Falsified Medicines Directive has been in force since 9 February 2019. Since then, most prescription and reimbursable medicines have had to be fitted with safety features. These safety features are checked at every stage of the distribution chain to guarantee the authenticity of the medicine.
The Belgian Medicines Verification Organisation (BeMVO) is responsible for managing the technical system for monitoring and validating the unique codes on medicines packaging. It guarantees the accuracy and efficiency of the verification process.