15/16 September 2020
The safety feature provisions entered into force on 9 February 2019. Member states are required to implement the new falsified medicines safety features for most prescription medicines which aim to prevent falsified medicinal products from entering the pharmaceutical supply chain. The safety features are placed on the packaging of the respective medicinal products by the pharmaceutical manufacturer and consist of the following:
The pharmaceutical manufacturer (on behalf of/or the marketing authorization holder, MAH) must upload the information from the 2D data matrix barcode into the European data repository after certification and before the product is released for sale or distribution.
Several Member States have formally advised those who may receive ‘unknown’ error messages to dispense anyway. Therefore, "the MHRA will also be taking a pragmatic, flexible approach to how we enforce the new legal requirements, as long as the normal checks are carried out, and there is no reason to think that the medicine is falsified". In Germany, for example, currently, the MAH has to carry out these checks during 7 business days. After this period the alert will be forwarded automatically to the authorities and reported as "instance of suspected falsification".
The MHRA recently issued a statement concerning how to handle the error messaging and false alerts that may occur in the system due to a number of reasons. It is important to follow the advice referred to in the statement. Any instance of suspected falsification (including physical signs of tampering) is to be reported under the Yellow Card Scheme by entering details in the ‘fake’ category.
Where the MAH (or manufacturer on their behalf) is notified by the alerting system that a data error has occurred against their products, they are to notify the MHRA if upon further investigation falsification is suspected. Further background explaining the alert management process is provided on the EMVO website. In addition, in case of data errors, preventive actions can be defined. For example if the serial number was missing in system or batch or expiry data mismatch:
For more information please read the post Falsified Medicines Directive: Safety Features on the MHRA Inspectorate blog.