Marketing Authorization Holders (MAH) & Parallel Import Authorization Holders (PIAH)

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

The affiliation fee is 9,000 EUR and the annual fee for 2021 is 10,500 EUR.

The annual fee for 2022, meaning the operational fee for the National Medicines Verification System (NMVS) will be the same as for 2021: 10,500 EUR/MAH.

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