3. My contract with ACS PharmaProtect GmbH
1. Why do I need a contract with ACS?
In the database system of ACS, the complete pack data, which are property of the pharmaceutical company, will be stored in trust for the German market and will be kept in stock for the verification in the pharmacy. Every pharmaceutical company, who places prescription medicines on the German market must upload his data into the system. Therefore, he needs to conclude a contract with ACS.
2. Who is the contracting partner of ACS PharmaProtect GmbH?
Every pharmaceutical company, which places prescription medicines under its own brand on the German market.
3. May I conclude a contract with ACS together with my subsidiary?
No, this is not possible, for the case that the subsidiary places medicines in its own responsibility on the German market. ACS concludes contracts with every single pharmaceutical company.
4. May I as a contract manufacturing organization (CMO) conclude a contract with ACS?
ACS PharmaProtect GmbH only concludes contracts with pharmaceutical companies, which places their medicines on the German market. Companies, which solely operate as CMO are not permitted to conclude a contract with ACS. Nonetheless CMOs can and shall be integrated in the serialization process by their contracting authorities. Therefore, as an CMO please talk to your contraction authorities.
5. Which services will be provided by ACS?
ACS provides their contracting partners with an access to the database system of the pharmaceutical industry (ACS-MAH system). In this system, your product master data and your pack data (especially the serial numbers) will be stored and held in stock for the verification. Furthermore, ACS provides an extensive reporting functionality in the ACS-MAH system for the optimization of your serialization processes.
6. May I conclude a contract with ACS even If I have not started the technical implementation yet?
Yes, the conclusion of the contract with ACS is also possible, even if you haven’t started any technical provisions in your company yet. You may use the support and trainings of ACS, test and familiarize yourself with the ACS-MAH system early and use this knowledge for your project planning.
7. How do I get the contract for the connection to the ACS database system?
If you are interested in a connection to the database system you will get the contract documents after sending a request to email@example.com.
8. Do any alternatives to ACS in Germany exist?
No. Article 32 (1) and (2) of the Delegated Regulation determines that in each EU member state only one repository and one database system of the pharmaceutical industry is permitted. The territory of each member state can be covered only by one national or supranational repository. Therefore, the data for the verification in Germany must be provided only to the ACS database system.
9. After February 9, 2019, what will happen to unserialized medicines, which have been placed on the market before the effective date?
Medicines, which have been placed on the market before February 9, 2019, are allowed to be sold till the end of their expiry date. Though, after February 9, 2019 it is only permitted to place serialized products on the market, which bear the unique identifier and the anti-tampering device.
5. The data upload to the ACS-MAH system
1. Which technical opportunities are provided to transmit data into the database system of ACS (ACS-MAH system)?
Currently there are three ways to upload data in the ACS-MAH system. The easiest way is a manual upload via the online portal. You may upload the pack data via drag & drop into the system. We also setup for you machine interfaces per order. With them you can upload your pack data to the system via a SFTP server. A further alternative is the upload via the EU hub. The pack data will be transmitted via the EU hub to our system.
2. Is it possible to upload aggregated data into the system?
Aggregated date cannot be handled by the database system of ACS PharmaProtect. Aggregation is not required by the Delegated Regulation, rather the verification of separate packs is stipulated by the Delegated Regulation. Therefore, the aggregation won’t be possible till the effective date on February 9, 2019.
3. Have serial numbers already been uploaded to the ACS-MAH system?
Yes, already today you can upload pack data to the ACS-MAH system, which will be stored for the verification in one of the pilot pharmacies. The upload of the pack data via the EU hub is already a possibility for the target country Germany, but you also may upload the pack data directly to the ACS-MAH system via the national interface.
4. Where do I apply for a machine interface for the ACS-MAH system?
We gladly provide you the order form for the set-up of a machine interface (either integration or production environment) on request. Furthermore, you may find the form with the costs details in the download section of the ACS-MAH system.