As it has been communicated previously, a very important milestone has been reached in the National Implementation of the European Medicines Verification System: Romania successfully passed the second EMVO (European Medicines Verification Organization) assessment, thus the National Medicines Verification System is now connected to the EU Hub production environment (more on this, please visit our news section and our LinkedIn page: LinkedIn Page).
Consequently, all MAH Companies and their potential On-boarding Partners (OBPs) are kindly requested to start uploading pack data destined for the Romanian market to the EU Hub (including those with a Unique Identifier/Serialized, which have already been produced and sent on the distribution chains) as soon as possible to achieve a successful project implementation.
As we are approaching this year’s 4th quarter, an aspect in need of clarification is the invoicing of the annual tax for 2019. As previously communicated, following the OSMR General Assembly’s decision of 20.06.2018, the annual tax for 2019 is 9,500 EUR.
The process of issuing the invoices for the MAH companies who have on-boarded OSMR, will be started soon, the payment deadline being set for December 15th, 2018. The entire invoicing process is lengthy as there are different corporate regulations and procedures for each MAH company. Therefore, a timely planning is required.
We want to thank you for your effort in helping us achieve the project’s milestones set up to this moment and we are counting on your unwavering support, as you have shown it since the beginning of this ambitious project.
Kindly be encouraged to continue visiting our organisation’s website and LinkedIn Page (OSMR-LinkedIn ) as we are constantly updating our pages, trying to keep you up to date with all the relevant information needed for an effective project implementation.
Contact: [email protected]