EU FALSIFIED MEDICINES DIRECTIVE WHAT NOW?
You have successfully implemented the EU Falsified Medicines Directive? Then you have accomplished a large step yet towards a GMP compliant serialization process! However, you may wonder about the high costs of your serialization strategy, the large dependency of your serialization provider and the limited flexibility to include new sub-contractors or distributors in your serialization program.
In addition to your existing serialization solution, the introduction of a complementary solution can solve the above-mentioned challenges and thus optimize your present strategy. Our BetterTrace Pharma-package is EMVO-proven and a cost-effective fall-back or even second solution for the serialization of pharma products and their upload in the national and international verification systems, e.g. the European Hub. We evaluate the status quo together with you and define which problems and challenges have to be overcome. After determining the need for optimization, you can either choose between one of the individual components or select the complete serialization solution.
The BetterTrace Pharma-package provides with its modules BetterID, BetterPack and BetterBase a cost-effective fall-back-solution for the forgery protection of prescription medicines. Apart from the generation of serial numbers and their activation through the upload in the NMVS (National Medicines Verification System) or the European Hub, the BetterTec Services GmbH also offers support for further components of your serialization solution. If you are in need of support for the Technical Onboarding of a second solution, the integration of suppliers and distributors, the marking of parallel or re-imports, the validation of the serialization components or even for the supply of a fall-back-solution, we would be happy to support you.
As a small company the BetterTec Services GmbH offers customized solutions and an all-round-support to their customers. For us you are not one among many others. Every customer is consulted individually and is looked after by a personal contact person.
Generating the Serial Codes
The Webservice BetterID provides a safe generation of serial numbers. These serial numbers will be supplied in the form of an export file and can be passed on to a printing system automatically or manually. By transmitting the serial numbers to an existing printing system, the serial-code can be printed on the folding boxes. The serial-codes can alternatively be printed on labels, which we will design according to your special needs. You want to print labels quickly and on your own? We can also provide a customized printing system.
Activating the Serial Codes
The module BetterPack serves to activate the actual circulated serial numbers. The data matrix codes of the packed folding boxes will be scanned, so that their serial numbers can be stored in a xml-file which can be uploaded in the verification system. The generated xml-files of the BetterPack application can either be uploaded manually in the national verification system or the European Hub. Alternatively, the data transmission can be integrated in the BetterPack application.
Converting the Serial Codes in a compatible Upload-file
Serial numbers generated and processed by contract manufacturers can be converted to the required file format of the verification system in the BetterBase application. The module BetterBase is a web-based application, which can be accessed from any computer. On the web mask there is an option to upload an excel file with the processed serial numbers. Within a mouse-click, the serial numbers can be converted into a compatible file for the verification system. This file can then be uploaded in the NMVS or the EU Hub.