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Home > Blog > Regulatory Affairs

Accessing the European Pharma Market: becoming a MAH through dossier adaptation (II)

The European pharma market is becoming more competitive and accessible through its effort to adopt globally acknowledged standards and requirements, it is not surprising the increasing interest of investors to this appealing market.

When a non-European company is considering investing in EU business opportunities different strategies may be implemented depending on the company needs. One of these possible strategies is becoming a MAH through dossier adaptation.

This option is recommended for Non-EU companies looking to adapt their own dossiers in order to be able to commercialise their own products in Europe through the adaptation of their manufacturing processes and facilities.

The dossier or multiple dossier must comply with European requirements and a bioequivalence study must be presented along with all the adapted documentation. An inspection must be carried out and once approved the company will be granted of a European MAH status. Once the company becomes a MAH is allowed to market their registered products along the European Union.

Deep local knowledge is crucial when a company is considering accessing this market to ensure a cost-effectiveness strategy and minimize time landing in EU.

At Azierta, we provide global support for accessing the European Pharma Market to Non-European companies. We are experts in Regulatory Affairs, Compliance and EU Requirements Related Services. For further information, please visit our website European Market Access Support Services, do not hesitate to contact us in case of any doubt.


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