"The key difference for non-EU companies is the requirement to appoint an EU-based contact person or entity to act as their permanent representative.
This ensures that the EMA has a reliable point of contact within the EU, facilitating communication and regulatory processes.
Other than this requirement, the benefits and support provided by the EMA are intended to be equivalent for SMEs regardless of their geographic location."
Ann: PharmAust Granted SME Status by European Medicines Agency, page-11
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