MAH transfer: transfer of a marketing authorisation to a new holder
An MAH transfer moves a marketing authorisation from one legal entity to another, making the new company legally responsible for the product.
For centrally authorised products the transfer follows Commission Regulation (EC) No 2141/96: EMA gives an opinion within 30 days and the Commission amends the decision. For national, MRP and DCP products each Member State runs its own national procedure, so an EU-wide transfer means many parallel filings with different forms and fees.
Common gaps: the new holder must be established in the EEA and have its pharmacovigilance system, QPPV and PSMF in place on the transfer date; packaging must carry the new holder's name within the transition period each authority allows; and pending variations need a clear owner.
Used in
After a transfer, compare updated artwork with the approved text in Print Proofreader before new packs are printed.
Related terms
- Type IA variation: minor change notified after implementationA Type IA variation is a minor change with minimal or no impact on quality, safety or efficacy, which can be implemented before the authority is notified.
- eCTD: electronic Common Technical DocumentThe electronic Common Technical Document (eCTD) is the electronic format for regulatory dossiers, organised in the five-module structure defined by ICH M4.
- QPPV: qualified person responsible for pharmacovigilanceThe QPPV is the named individual, resident in the EU, who is personally responsible for a marketing authorisation holder's pharmacovigilance system.
- PSMF: pharmacovigilance system master fileThe pharmacovigilance system master file (PSMF) is the holder's detailed description of its pharmacovigilance system, kept in the EU for inspectors.
- MA withdrawal: voluntary withdrawal of a marketing authorisationAn MA withdrawal is the holder's decision to give up a marketing authorisation, notified to the authority with its reasons and any supply consequences.
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