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.
The system was completed with an API interface that allows the connection of end-user software and MAHs. The API solution also includes a web portal, which makes the API functionality available to users without their own alert management software.
- 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)
- Alerts management_CZMVO_7.2.2019_EN_final.pdf (5 MB)
- Group Closure manual_ EN.pdf (1 MB)