On-boarding to EU HUB and responsibilities to NMVO
EMVO on-boarding, NOOL contracting and Fee payments are topics important to all marketing authorisation holders and pharmaceutical companies.
Attached document should provide you a guidance regarding your on-boarding to the European Medicines Verification System (EMVS) and to clarify the difference between EMVO on-boarding and NMVO (NOOL) contracting, and the fees in general.
The final version of the contract template between MAHs and NOOL should be available by the end of the Q1/2018 and communicated to each MAH together with the proposed fee - one time registration fee and annual flat fee model being review currently.
More details about the topic in general can be found in the attached document.