{"id":865,"date":"2020-02-17T14:56:03","date_gmt":"2020-02-17T14:56:03","guid":{"rendered":"https:\/\/newsite.osmr.ro\/?page_id=865"},"modified":"2026-04-08T12:10:02","modified_gmt":"2026-04-08T12:10:02","slug":"dapp","status":"publish","type":"page","link":"https:\/\/osmr.ro\/en\/dapp\/","title":{"rendered":"MAH & PIAH"},"content":{"rendered":"

Marketing Authorization Holders (MAH) & Parallel Import Authorization Holders (PIAH)<\/span><\/span><\/strong><\/h3>\n
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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.<\/strong><\/h3>\n<\/blockquote>\n

\u00a0 \u00a0 \u00a0 The affiliation process involves the following steps:<\/strong><\/p>\n

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  • \u00a0Contacting the OSMR responsible person via a dedicated email address: dapp_mah@osmr.ro in order to obtain the necessary registration documents<\/li>\n
  • Sending the respective documents to the OSMR responsible person, scanned first, then in hard-copy, by post to the communicated address<\/li>\n
  • Payment of the membership and annual fee based on the invoice issued by OSMR<\/li>\n
  • Electronically receipt of the OSMR membership certificate<\/li>\n<\/ul>\n

    Note:<\/strong>
    Starting with February, 2026, the newly affiliated members (MAH) of OSMR shall pay the annual membership fee calculated on a pro rata<\/em> basis, starting from the month of enrollment, for the current calendar year.<\/p>\n

    During the most recent OSMR General Assembly, which was held on August 26th, the financial outlook and market landscape for the upcoming year were reviewed. After careful consideration, it was agreed to maintain the<\/strong> operational fee for the NMVS for 2026 at the same level as last year: 9,000 EUR\/MAH, and to lower the affiliation tax to the amount of 3,000 EUR\/MAH.<\/strong><\/p>\n

    As in the previous years, after a thorough analysis of the budget and having an overview of the MAHs which are marketing their serialized products on the Romanian market, it has been decided that the amount of the operational fee for the NMVS for 2025 remain the same as for the current year: 9,000 EUR\/MAH<\/strong>.
    \nAlso, the amount of the affiliation tax remains the same: 5,000 EUR<\/strong>.<\/p>\n

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

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

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

    The affiliation fee<\/strong> is 9,000 EUR<\/strong> and the annual fee for 2021<\/strong> is 10,500 EUR<\/strong>.<\/p>\n<\/div>

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    Categories<\/h4><\/div>