Only two years remain until the activation of the protection for counterfeit medicines
Today, exactly one year ago, the European commission published the Delegated Regulation (EU) Nr. 2016/161 with the specification of the requirements from the FMD. From the experiences of our first 100 project participants, it becomes apparent that the remaining two years are a short time to implement the requirements for pharmaceutical companies which have not started yet.
The transition of processes in the companies takes time and a good planning. The data management and the adoption of your pack material are important points which must be considered. The adoption of packaging lines, the choice of suitable partners and the coordination of the test steps take time and resources. The good news: the database system of the pharmaceutical industry is already completed, so that your company can connect to the technical system of securPharm via ACS PharmaProtect. In Germany you can test the upload of the verification data via the national interface and the European hub. That’s why we recommend: Fully adapt already till the end of 2017, so that from beginning of 2018 one year still remains to test and train the processes under real life conditions, and without the danger that occuring faults do result in a dispensing stop of your medicines in a pharmacy.
Make the first step to implement the requirements and start now with securPharm, so that your products remain marketable after February 09, 2019. securPharm e.V. is the German NMVO (National Medicines Verification Organization) and develops since 2011 the technical system for the authentication of medicines obliged for verification.
What do you have to do for connection to the database system? We from ACS PharmaProtect are always at your service. Please feel free to contact us. As pharmaceutical company which offers prescription drugs into the German market and that are affected by the Directive 2011/62/EU, you will need to conclude a contract with ACS PharmaProtect GmbH. ACS is the operator of the database system operator of the pharmaceutical industry, in which your product and pack data will be stored for a verification in the pharmacy.
By an early start you do not only profit from the knowledge sharing with other project participants and the extensive consulting in your specialist questions, but also profit financially, due the drafting of our fee model, by a near-term connection to the database system.
More information regarding the contract and our fee model you receive from our competent ACS Customer Recruitment- and Relationship Management team:
Mrs. Maria Mehnert
phone: +49 (0)30 577 037 907
Mr. Martin Altkrüger
phone: +49 (0)30 577 037 902
Please remind: If you already concluded a contract with EMVO for connecting to the EU-Hub, you also need to conclude a contract with ACS PharmaProtect GmbH. Otherwise your pack data (including the serial numbers) will not be stored in the ACS-MAH-system and cannot be checked for the verification in the pharmacies and the wholesalers.