14/15 June 2021
From 9 February, 2019 onwards, prescription drugs may only be entered into the German market if their packaging bears a unique identifier and the integrity of the medicinal product is visibly recognisable.
The EU Delegated Regulation provides clarity in many cases; however, there are still many unanswered questions of detail.
The coding will be in data matrix code as per ISO/IEC 16022. Thereby, the machine readability of the data element is given. The pharmaceutical manufacturer has to equip each and every packaging of a drug product that is subject to mandatory verification with the required safety features during the production process. The application of safety features may not be done "just like that"; the competent authority must be informed beforehand. This also applies for medicinal products that were already authorised. Samples for physicians must bear the safety features, as well.
The national competent authorities have a special role in the organisational structure. They are responsible for monitoring the system and have to verify the compliance with the Delegated Regulation and the Falsified Medicines Directive.
Furthermore, there may only be one national organisation responsible for the verification (National Medicines Verification Organisation/NMVO) per EU member state. Said organisation is responsible for the respective national system for authenticating medicinal products that are subject to mandatory verification.
securPharm plays this part in Germany. Therefore, securPharm has already connected to the European hub as a national NMVO.
On the current state of the project, the report states that more than 200 pharmaceutical companies are participating now (as of December 2017). They are large global operators as well as medium-sized enterprises.
As a conclusion, the report says it's about time for pharmaceutical companies to confront the technical and organisational challenges connected with implementing the EU Falsified Medicines Directive.
Please also see the complete securPharm status report 2018 for more information.