Producers - MAH - Parallel Distributors
Marketing authorisation holders (MAHs) or Parallel distributors who market products in the Czech Republic must ensure that prescription-only medicine packs released for the Czech market from 9th February 2019 carry unique identifiers and anti-tamper devices according to the EU Directive 2011/62/EU - also called the Falsified Medicines Directive (FMD) and the data for the products are uploaded in the system.
NOOL ALERT MANAGEMENT SYSTEM
The alert management system operated by NOOL is a support system for the CZMVS (NSOL). The purpose of this support system is to facilitate the administration associated with alert investigations and to help automate the entire investigation process.
Alerts can be managed in several ways:
A. Response to the NOOL's "clickable" email.
Existing system - can continue to be used. However, it will not be further developed.
B. NOOL web interface for alert management
For users who do not have their own alert management system or do not allow direct integration of their organization rules, access to the NOOL alert management system is available via a user-friendly web interface.
C. Direct NOOL API communication
Integration of user's own alert management system with alert management system operated by NOOL via API communication.
Request to join the NOOL web interface or NOOL API should be sent to email@example.com
Please note: the test environment will be available to the interested person first and afterwards (after the MAHA e-mail confirmation) the production environment will be switched on - at that moment the sending of “clickable” e-mails will be turned off. You cannot use both systems at the same time!
- EMVO - AGREEMENT FOR PARTICIPATION IN ON-BOARDING PROJECT-SAMPLE.pdf (508 KB)
- EMVO - NON-DISCLOSURE AGREEMENT FOR PARTICIPATIO-SAMPLE.pdf (234 KB)
- EMVO - On-Boarding - How to connect to the EU Hub.pdf (1 MB)
- EMVO - On-boarding Guideline-Manual for MAHs and Parrallel distributors.pdf (1 MB)
- OBP On-boarding_Guideline_latest version.pdf (1 MB)
- 15.12.2017_ Letter of Announcement_On-boarding Fee.pdf (432 KB)
- EMVO On-boarding - NMVO contracting Letter of Announcement_Final Version.pdf (256 KB)
- Group closure manual EN verze 2020.pdf (966 KB)