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 marketing authorization holder (MAH), you need to conclude a contract only 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 marketing authorization holder (MAH), will be stored in trust for the German market and will be kept in stock for the verification in the pharmacy. Every marketing authorization holder (MAH), 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 marketing authorization holder (MAH), 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 marketing authorization holder (MAH).

4. May I as a contract manufacturing organization (CMO) conclude a contract with ACS?

ACS PharmaProtect GmbH only concludes contracts with marketing authorization holder (MAH), 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.

10. What is the group rebate?

The group rebate is designed for Affiliated Companies. Should Affiliated Companies spread their marketing authorizations across multiple marketing authorization holders, they can now benefit from our degressive fee model in the same way as if they had pooled all their marketing authorizations on one marketing authorization holder.

11. How to apply for the group rebate

A group rebate is available to an Affiliated Company upon application. The applicant must be a customer of ACS and be an Affiliated Company with one or more ACS customers. The application form can be found here.

12. How does the group rebate work?

All companies who were eligible for a group rebate will in a first step receive their invoices as usual, including for the annual fee. For a group rebate, ACS in a second step adds up the Number of Packages and Product Turnover of all affiliated companies and determines the corresponding annual fee. ACS will reimburse the difference between the so determined annual fee across all Affiliated Companies and the total of the invoices for the annual fee of each individual Affiliated Company to an account designated by the applicant. Any equalization of the reimbursement amount among the Affiliated Companies is the responsibility of the applicant.

13. What are Affiliated Companies?

Affiliated Companies refer to affiliated companies as defined in sections 15 et seq. German Stock Corporation Act (AktG). Affiliated companies are therefore independent companies that are majority-owned and majority-participating companies in relation to each other (see FAQ 14), dependent and controlling companies (see FAQ 15), group companies (see FAQ 16), mutually participating companies or parties to an intercompany agreement.

14. What are majority-owned enterprises and majority-held enterprises?

If the majority of the shares of a legally independent company belong to another company or if another company has the majority of the voting rights (majority shareholding), the company is a majority-owned company and the other company is a participating company with a majority shareholding.

15. What are dependent and controlling companies?

Dependent companies are legally independent companies over which another company (controlling company) can directly or indirectly exercise a controlling influence.

16. What are group companies within the meaning of sections 15 et seq. German Stock Corporation Act (AktG)?

If a controlling company and one or more dependent companies are combined under the uniform management of the controlling company, they form a group; the individual companies are group companies.

If legally independent companies, without one company being dependent on the other, are combined under uniform management, they also form a group; the individual companies are group companies.

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 marketing authorization holder (MAH) has the choice to upload the data via the EU hub.

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 marketing authorization holder (MAH) 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)?

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.

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, marketing authorization holder (MAH), 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.