The Falsified Medications Directive came into effect on February 9, 2019. The FAMHP has bundled a few practical guidelines for handling the problems in the start-up phase in a newsletter and has decided to set a transition period.
From February 9, 2019, most of the prescription and reimbursable medicines on the market must bear safety features. At each link in the distribution chain, the safety features must be checked so that the authenticity of the medicine upon delivery can be guaranteed. Even though the roll-out in Belgium runs relatively quickly, the verification system will probably have some growing pains through the high complexity, both in the area of informatics developments and adaptations to the production and distribution chains.
BeMVO has created an "alert” procedure together with the FAMHP for “alerts” or error messages when a product is scanned. This step procedure, the first of its kind in the entire European Union, must be followed in the case of error messages when products are scanned. Experience in the development and testing of the system has shown that above all in the first weeks after the system becomes operational, one can still expect some error messages not related to forgeries. For example, there may still be products, sold before February 9, 2019, with a unique code that is not in the system. It may also be a product for which the code attached is not correct or possible other faults in the software developed. Through these errors, it is possible that products may not be recognized by the database, but the FAMHP is of the opinion that this should not be considered as a “suspicion that the product is not compliant”.
The FAMHP has therefore decided that until April 30, 2019, the legislation must be interpreted as laid out in circular 644 (Dutch or French only). During this transition period, the focus will remain on guaranteeing the availability of drugs for patients without eroding the new protection offered by the directive.
For example, it will be permissible for the pharmacist to deliver the products, even if the scan results in an error message. There are a few requirements for this:
- The pharmacist always scans and deactivates the unique identification feature on the package.
- If there is an error message:
- The pharmacist checks whether the package is compliant (no deviations from the regularly delivered packaging). If there is doubt, the drug is not delivered.
- The pharmacist checks whether the“anti-tampering device” is intact. If there is damage, the drug is not delivered.
- The pharmacist ensures that he has not purchased from a new, not regular supplier. If there is doubt, the drug is not delivered.
- The pharmacist delivers the drug only if the aforementioned controls are in order.
- The pharmacist registers the unique identification feature to later deactivate it, after the technical problems are solved.
Other specific recommendations for pharmacists, marketing license holders for a drug, holders of a manufacturing or distribution license are listed in circular 644.
Watch the video for more explanation:
Circular 644 (Dutch or French only)
BeMVO (Belgian Medicines Verification Organisation)
Guideline 2011/62/EU of Falsified Medicines Directive, FMD
New verification system against falsified medicines in each link of the distribution chain.