Positioned as the second largest pharmaceutical market in the world and showing a steady and extensive growth pattern, Europe’s pharma market is becoming increasingly attractive, but accessing this market implies both regulatory and technical requirements, so different strategies need to be considered to ensure cost-effectiveness.
One of the options available for companies seeking to capitalize on EU business opportunities is becoming a MAH through the purchasing of a dossier or multiple dossiers of products manufactured in EU facilities.
It is a must to audit and to ensure that the dossiers already comply with European regulation and after the acquisition, a non-EU company can obtain European MAH status which allows to market medicinal products in one or more EU member states. In terms of manufacturing, the company can transfer the processes of the different products acquired to their own facilities outside Europe by obtaining the European GMP certificate.
Other strategies are also possible to access the European market and can be implemented on an individual basis or alongside each other, depending on the clients needs.
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.