We are the OBP and the MAH, do we need to sign a Letter of Adhesion?
November 9, 2018 8:26 amThe purpose of the Letter of Adhesion is for the MAH to adhere to the Participation Agreement between EMVO and... View Article
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Where can we find the new Participation Agreement?
November 9, 2018 8:23 amThe new Participation Agreement template is now available on the OBP Portal: If you have already signed the previous Participation... View Article
We have already signed the original Participation Agreement (PA), do we need to sign the PA published in November 2018?
November 9, 2018 8:21 amYes. As mentioned in the related Letter of Announcement, the new Participation Agreement governs the Operational Phase of the EMVS,... View Article
How to fill in the Product Master Data and Product Batch/Pack Data in the EU Hub? Which information to include?
September 28, 2018 10:58 amPlease consult the Master Data Guide, also available on EMVO website. The key data fields have to be filled-in according... View Article
How to set up the coding for the different countries?
September 28, 2018 10:57 amThe product codes to be uploaded in the EU Hub have to follow the coding requirements of each country where... View Article
Why it is important and how to fill in the Company Type?
August 28, 2018 7:33 amAs the connection of the Original Pack Manufacturer and Parallel Distributer differs (please see FAQ 2.05), and therefore an OBP... View Article
How to on-board (a) MAH(s) separately though having a registered OBP, which on-boards MAH/s?
August 28, 2018 7:31 amIt is possible to on-board (a) MAH(s) separately though there is already a registered OBP. A MAH or MAHs can... View Article
What is the difference between the connection of an Original Pack Manufacturer to the Hub and the connection of a Parallel Distributor/Importer to the HUB?
August 7, 2018 2:26 pmThe Connection of an Original Pack Manufacturer allows to upload original pack data to the EU Hub. The Parallel Distributor... View Article
What is the difference between Parallel Distribution and Parallel Importation?
August 7, 2018 2:15 pmCentrally authorised medicinal products (“CAPs”) put on the market of one Member State can be marketed in any other Member... View Article
What is a SPOC and SPOC Assistant?
April 18, 2018 11:44 amThe Single Point of Contact (SPOC) is the key contact person for EMVO and is authorised by the Authorised Representative... View Article