Marketing Authorisation Holders
MAH obligations in line with Directive 2011/62/EU (Falsified Medicines Directive)
From 9th February 2019 most prescription medicines placed on the market in Europe need to have safety features in the form of unique identifiers and anti-tamper devices. These requirements are set out in the Directive 2011/62/EU (Falsified Medicines Directive) and the Commission Delegated Regulation (EU) 2016/161. Marketing Authorisation Holders (MAHs) must also register with the national organisations in charge of setting up the system.
For more information please read Letter to Stakeholders.
Onboarding to EMVO
On-Boarding Partners (Original Pack Manufacturers and Parallel Distributors) need to onboard to the EU Hub which is managed by EMVO. For detailed information regarding the EMVO onboarding process which has both contractual and technical elements, please visit EMVO website or read EMVO Onboarding Guideline.
Also, unique identifier data on the packs must be uploaded to EU Hub. The data will then transfer from the EU Hub to the national repository for the market where the packs are intended to be sold.
Onboarding to CMVO
In Croatia the national system is set up and managed by the Croatian Medicines Verification Organisation (CMVO). The MAH onboarding to CMVO includes signing of Participation Agreement and payment of fees. To start with the onboarding process, please contact us at .
The Regulation states that the pharmaceutical industry is responsible for the co-financing CMVO costs such as the costs for developing, implementing, operating and maintaining the CMVS, the costs for connecting the CMVS to the European Hub, any costs charged to CMVO by EMVO, etc.
MAHs contribute to the coverage of the above mentioned costs with:
– a one-off Registration Fee into the Program (“registration into the Program”), which is HRK 50,000.00 for new MAHs
– an Annual Fee in the amount of HRK 53,000.00 for the year 2019
– an Annual Fee in the amount of HRK 50,000.00 for the year 2020