Marketing Authorization Holders & Parallel Import Authorization Holders
The Marketing Authorisation Holders and Parallel Import Authorisation Holders connect to the European Hub via the OBP (On-Boarding Partner) and ensure that the information related to medicines with unique identifiers is uploaded to the European Hub.
The affiliation process involves the following steps:
– Contacting the OSMR responsible person via a dedicated email address: dapp_mah@osmr.ro in order to obtain the necessary registration documents
– Sending the respective documents to the OSMR responsible person, scanned first, then in hard-copy, by post to the communicated address
– Payment of the membership fee based on the invoice issued by OSMR
– Electronicaly receipt of the OSMR membership certificate
Starting with July 1st 2018, the OSMR affiliation fee is 9.000 EUR.