With only 219 days left until the Go-live of the European Medicines Verification System, on February 9th, 2019, we would like to inform you about the latest updates of the project implementation, especially those related to our national repository system.
As you can also find out from our website (news section): https://osmr.ro/category/news/?lang=en and our LinkedIn page: https://www.linkedin.com/company/osmr-romanian-organisation-for-serialising-medicines/ which we encourage you to visit, OSMR has reached an important milestone on its implementation path of the NMVS (National Medicines Verification System) – it has passed the 1st assessment organized by EMVO (European Medicines Verification Organization).
Currently, actions are undertaken so as to successfully meet the requirements of the next step of the implementation: the 2nd EMVO assessment, allowing for the PILOT phase to begin in August. Please bare in mind that this is an estimated date which might be subject to change. During the PILOT phase, all entities impacted by the project will be called upon, by voluntary participation, to test the system in the Productive environment (NMVS PROD) from their end-user locations.
An important announcement for MAH/ Parallel Distributors, which are already enrolled or want to become OSMR affiliated members: the OSMR Board has decided that the amount of the annual fee for 2019 will be 9.500 EUR. It has been calculated so as to be able to cover the operational budget for the respective year and to ensure the required financial sustainability.
Please be informed that the payment for this fee needs to be done in due time so that we will be able to ensure the running costs of NMVS and of the database system for 2019.
For all the pharmaceutical companies which need to on-board EMVO (European Medicines Verification Organization) in order to upload all relevant data to the EU Hub, we would like to remind you that connecting to the EU Hub is done via an On-Boarding Partner (OBP). The OBP is the contracting party of EMVO and concludes the Participation Agreement. It is legally authorized to sign on behalf of a MAH / a group of MAHs. As stated in a FAQ document on EMVO website (https://emvo-medicines.eu/knowledge-database/#faq), for smaller companies the MAH and OBP could be the same.
For more information related to this procedure, please visit the EMVO website: https://emvo-medicines.eu/pharmaceutical-companies/
We would also like to bring to your attention a section of our website where you will soon find information available: Equipment and professional solutions – https://osmr.ro/echipamente-si-solutii-profesionale/?lang=en which is dedicated to publishing information which might be relevant to all stakeholders in this project in terms of equipment and professional solutions existing on the market.
Contact: [email protected]
