Marketing Authorisation Transfers

We provide comprehensive regulatory affairs support related to Marketing Authorisation Transfers and acquisitions of medicinal product licenses. Our team has extensive experience in handling individual product license transfers (single license acquisitions, out-licensing, in-licensing) and managing large-scale Marketing Authorisation Transfers related to strategic divestments / purchases or pharmaceutical Mergers & Acquisitions (M&A).

We can help you evaluate the gaps of the Dossier(s) in the scope of the transfer, strategise and effectively implement the Marketing Authorisation Transfer process on a regional level, and assist you with the complete post-approval regulatory change implementation. Our services cover all countries in the European Union and CIS region, and our Local Regulatory Affairs teams can help you with full MAT implementation in each country of scope.

If you are planning a Marketing Authorisation Transfer project, you may also find our blog article about the Marketing Authorisation Transfer Considerations worth reading.

Services Offered:

Regulatory due diligence and preparation of due diligence report

Marketing Authorization Transfer submission strategy on regional and country-level

Marketing Authorization Transfer process management

Management of variations in parallel to the Marketing Authorization Transfer and post-approval

Gap-assesment of the transferred / obtained dossier

Artwork updates after the Marketing Authorization Transfer

Product reimbursement status and pricing updates after the Marketing Authorization Transfer

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Marketing Authorization Transfer projects supported
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Countries covered
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Local regulatory experts

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Marketing Authorization Transfer Considerations

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