Marketing authorization support for sponsors outside EU
Registrations in the EU are only granted to European (i.e. EEA) based marketing authorization holders (MAH). Once registration is granted, the MAH has to continuously update the marketing authorisation and inform regulatory agencies of any changes affecting the (use of) the product.
To facilitate registration of medicinal products in the Europe for companies that do not have an establishment within the Europe. Kinesis can temporarily act as EEA established MAH for the purpose of obtaining a marketing authorisation and take care of specific EU requirements, as appointing an QP-PV, which has to reside in Europe, and selecting a manufacturing (import) authorisation holder and QP for batch release in the EEA.