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My contract with the ACS PharmaProtect GmbH
Pursuant to Art. 33 (1) of the Delegated Regulation (EU) 2016/161 ("DVO"), the contractual partners of the ACS are
- Any Marketing Authorization Holder (MAH) who places (has placed) on the market in Germany medicinal products subject to verification under his name or through third parties.
- Parallel importers and parallel distributors of medicinal products subject to verification.
In the database system of ACS, the complete package data for the German market, which remain the property of the MAH, are stored in trust and held for verification in the pharmacies and dispensing offices. The associated use of the national storage system is subject to fees. In particular, these fees and rights of use are agreed in the cooperation agreement between you and ACS.
Please send us an e-mail with a request to conclude a contract with ACS to firstname.lastname@example.org. As part of the contracting process, you will go through an ACS internal legitimation process. In this process, you will be asked to provide us with legitimation-relevant documents, such as a current excerpt from the commercial register and documents relating to an exemplary pharmaceutical product, for verification. In case of a positive legitimation, you will receive the current cooperation agreement for signature. You can view the cooperation agreement in advance here.
No, this is not possible. ACS concludes a contract with each marketing authorization holder (MAH), Parallel Importer or Parallel Distributor individually.
ACS PharmaProtect GmbH only concludes a contract with marketing authorization holders (MAH) who place their medicinal products on the market in Germany. Therefore, companies that act exclusively as contract manufacturers cannot conclude a contract with ACS. However, CMOs can and must be included in the serialization process by their principals. Therefore, as a CMO, contact your client.
ACS gives its contract partners access to the database system of the pharmaceutical industry (ACS MAH system). In this system, your product master and package data (especially the serial numbers) are stored and kept for verification.
In addition to the mandatory services, the cooperation agreement also includes additional voluntary services provided by ACS, such as extended reporting of the package data provided for Germany and national alert management.
Yes, concluding a contract with ACS is also possible if you have not yet created any technical prerequisites in your company. You can take advantage of ACS's support and training measures, familiarize yourself with the ACS MAH-system at an early stage and already incorporate this knowledge into the project planning.
If you have decided to connect to the database system, you can obtain the contract documents on request at email@example.com.
No. The Delegated Regulation stipulates in Art. 32 (1) and (2) that there may be only one data repository and only one pharmaceutical industry database system in each member state of the EU. The territory of each member state may only be covered by one national or supranational data repository. In Germany, the data for verification may thus only be held in the ACS database.
The data upload to the ACS MAH system
The package data and product master data are transmitted to our system via the EU hub.
Before a parallel importer can repackage the packs, the purchased packs must first be checked out. After the pharmaceuticals are repackaged and relabeled, the new Data Matrix code must also be activated here and the data uploaded to the data storage and retrieval system. These functionalities can only be performed in the EU Hub.
According to the delegated regulation, hospital pharmacies and hospital-supplying pharmacies must also carry out a verification of the medicinal products before they reach the patient. Therefore, the Marketing Authorization Holder (MAH) , who only markets hospital goods, also requires a contract with ACS PharmaProtect for the provision of its packaging data in the German market.
ACS PharmaProtect GmbH and securPharm
ACS PharmaProtect GmbH is the operating company of the database system of the pharmaceutical industry (ACS-PU system) and thus part of the data storage and retrieval system for which securPharm e.V. is responsible and which is required by the Delegated Regulation implementing the Falsified Medicines Directive. The shareholders of ACS PharmaProtect GmbH are the pharmaceutical associations BAH, BPI, Pro Generika and vfa.
securPharm e.V. is the organization responsible for setting up the technical system for authentication in Germany. This system is divided into two subsystems. The pharmacy system is operated by NGDA - Netzgesellschaft deutscher Apotheker mbH and the database system of the pharmaceutical industry is operated by ACS PharmaProtect GmbH. As a marketing authorization holder (MAH) in Germany, you only need a contract with ACS.
MY MEDICINAL PRODUCTS ARE AFFECTED BY DELEGATED REGULATION (EU) 2016/161
Your medicinal products are affected by the directive if they are available only on prescription and do not fall under the exemption according to Annex I, as well as OTC medicinal products listed under Annex II of Delegated Regulation (EU) 2016/161. Please note that OTC medicinal products in Germany may be subject to prescription in other EU countries.
EMVO and EU Hub
The EU Hub, together with the national data storage and retrieval systems, forms the European verification system. The EU Hub is operated by the European Medicines Verification Organisation (EMVO). Product and package data are routed to the country-specific databases via the EU Hub. For the German market, the marketing authorization holder (MAH) has the option of uploading his data via the EU Hub or the national interface.
To use the entire European Verification System, it is necessary to conclude the Participation Agreement with EMVO. For more information, please visit www.emvo-medicines.eu.
A contract with EMVO alone is not sufficient. As a marketing authorization holder (MAH), you also need a contract with the national verification organizations in the countries where you distribute medicinal products subject to verification.
ACS PharmaProtect GmbH