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: [email protected] 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 and annual fee based on the invoice issued by OSMR
  • Electronically 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.

For 2023, the amount of the operational fee for the National Medicines Verification System (NMVS) has been set for 10,000 EUR/MAH. The difference in the amounts set during the previous years comes from the positive dynamics of the affiliated members.

Following the OSMR General Meeting of July 5th, 2023, the affiliation fee has been decreased to 5,000 EUR, and the operational fee for the NMVS for 2024 has been set for 9,000 EUR/MAH.

Thus, the descending trend which started last year is continuing also this year. However, because the budget is directly dependent on the MAHs interest to continue marketing on the Romanian market, the amount of both the affiliation and the operational fee can differ from one year to another.

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