MAA Application Support

EU QP Declarations

MIAS assists companies with their MA (Marketing Authorisation) application or IMPD by providing an EU QP Declaration to substantiate their submission.

“A QP Declaration is required from each registered EEA manufacturer and Importer Authorisation Holder (MIAH) that uses the active substance as a starting material and/or is responsible for QP certification of the finished
batch of a human or veterinary medicinal product.” – European Medicines Agency

A QP Declaration is generally done by either the QP carrying out a personal on-site audit or a review an audit conducted by a qualified third party.

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