New End-Users Agreement of NMVS Use

New Agreement for the Use of NMVS by End-Users, including the License Terms for the Use of the Alert Management System acceptance

The Board of Directors of Národní organizace pro ověřování pravosti léčiv, z.s.  (National Medicines Verification Organization - NMVO) has approved the new version of the Agreement for the Use of the NMVS by End-Users. The changes reflect some requirements formulated by representatives of European stakeholders (including pharmacy and wholesaler organizations), while some changes respond to the development of the system and legislation. For these reasons, the Agreements were gradually updated in other EU Member States as well. These changes improve the conditions for End-Users in terms of the protection of their data and the handling of the data in the NMVS.

In particular the following changes have been made:

• Some provisions have been clarified based on stakeholders’ suggestions;
  • The ownership of data in the EMVS (it has been clarified who owns which data);
  • The handling of data in the Audit Trail (the conditions, under which the NMVO Representative can access the Audit Trail, have been clarified);
  • Information provided by the NMVO to the End-User about the disclosure of the End-User’s Data in the NMVS to national authorities, all this including the specified exceptions (the explicit right of the Data Owner to request information about national authorities’ access to his Data has been added);
  • The verification of medicinal products and the decommissioning of unique identifiers only with regard to the medicinal products, i.e. packs, under the physical control of End-Users;
  • The NMVO's obligation to adopt reasonable measures to protect the identity of End-Users;
• Obsolete and outdated provisions have been removed (the provisions that are no longer actual or are outdated have been deleted);
• The provision that this new Agreement supersedes any previous arrangements has been added (this provision is aimed at the cancellation of the existing agreement mentioned at the beginning of the Agreement and its replacement by the new Agreement);
• The instruction on the processing of personal data by the NMVO in compliance with the GDPR in connection with the Agreement has been added; the new article of the Agreement and the new annex to the Agreement (an annex on the processing of personal data, which provides information about the processing of personal data, about contact details for these purposes as well as about the rights of data subjects, has been added);
• The explicit requirement for End-Users to inform the NMVO about any major changes concerning End-Users, i.e. changes that could affect the rights and obligations arising from the Agreement, has been added. This information duty is usually required by law; however, the new Agreement lists the major changes that, as a rule, will affect the rights and obligations arising from the Agreement;
• The explicit possibility to amend the Agreement (i.e. to conclude amendments) in the future in electronic form as well has been added. This will be used mainly to simplify the acceptance of future versions of the Agreement and to amend the License (see the next paragraph), which could be changed by acceptance in the electronic system;
• The License to use NMVO AMS (Alert Management System), which constitutes an annex to the Agreement, has been added. The License largely copies the provisions of the Agreement and is necessary as a legal title for the proper use of NMVO AMS by End-Users. The License formalizes the rights to use NMVO AMS, which are granted free of charge. It also establishes the framework for using NMVO AMS. The License also assumes the potential future connection of the Czech NMVO AMS to the European system.

In the upcoming weeks, all NMVS End-Users will receive a letter with instructions on where and how the Agreement can be signed.

The template Agreement is already available at the NMVO’s website  here.