1. ACS PharmaProtect GmbH and securPharm

1. Who is ACS PharmaProtect GmbH?

ACS PharmaProtect GmbH is the operator of the database system of the pharmaceutical industry (ACS-MAH system) and thereby a part of the data repository by securPharm e.V., which is required by the Delegated Regulation for the implementation of the Falsified Medicines Directive. The stakeholder of ACS PharmaProtect GmbH are the pharmaceutical associations BAH, BPI, Pro Generika and vfa.

2. What is the relation between securPharm and ACS?

securPharm e.V. is the responsible organization for the development of the technical system for the authenticity check in Germany. This system is divided in two sub systems. 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. For Germany, as a pharmaceutical company, you only need to conclude a contract with ACS.

2. Are my medicines affected by the Delegated Regulation (EU) 2016/161?

1. Are my medicines affected by the Falsified Medicines Directive?

Your medicines are affected by the directive, if they are available only on prescription and are not covered by the exemption set out in annex I and OTC medicines listed in annex II to the Delegated Regulation (EU) 2016/161. Please note that OTC medicines in Germany may be subject to prescription in other EU countries.

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 info@pharmaprotect.de.

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.

4. EMVO and EU-Hub

1. What is the European hub (EU hub)?

Together with the national repositories, the EU hub forms the European verification system. The EU hub is operated by the European Medicines Verification Organization (EMVO). Via the EU hub the product master data and the pack date will be transmitted to the country-specific repositories. For the German market, the pharmaceutical company has the choice to upload the data via the EU hub or the national interface.

2. Do I need a contract with EMVO for the connection to the European hub?

When you want to use the entire European verification system the conclusion of a participation agreement with EMVO is mandatory. Please find more information on www.emvo-medicines.eu.

3. I have already concluded a contract with EMVO for the connection to the European Hub - is that sufficient?

The contract just with the EMVO is not sufficient. As pharmaceutical company you also need contracts with the national organizations in the countries where you place products on the market, which must be verified, since these organizations are responsible for the operation of the national verification systems. This is due to the fact that the serial numbers are only stored in the national systems and need to be provided for the verification in the dispensing points. Therefore, contracts with the national operating companies are mandatory.

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.

6. Parallel import

1. Which special requirements must be met by parallel importers?

Before a parallel importer can re-pack the content, the purchased packs must be checked out first. After the medicines are repacked and labeled anew, the new data matrix code must be activated and the data uploaded to the repository. These functionalities can only be performed in the EU hub.

7. Hospital packs

1. I produce only packs for hospitals. Am I obliged to connect to the database system of ACS PharmaProtect?

In accordance to the Delegated Regulation hospital pharmacies and pharmacies servicing hospitals are also required to verify medicines before dispensing. Because of that, pharmaceutical companies, who just place hospital packs on the market, also need a contract with ACS PharmaProtect for the storage of pack data for the German market.