Q&A Document on the QP Declaration revised

Recommendation

26-28 April 2023
Hamburg, Germany

Qualified Person Education Course Module A PLUS IMP Pre-Course Session
Understand the Implications of becoming a QP

The CMDh* has revised and published its Q&A document on the QP Declaration.

Mainly adjustments were made due to the new Veterinary Medicinal Products Regulation (EU) 2019/6. Also, in several answers a differentiation was made between human and veterinary medicinal products.

Adjustments were also made to question 3 "When the only change in an updated CEP is the name of the HOLDER (the manufacturing site remains the same) what is the rationale for requiring a new QP Declaration?". The additions here can be found in the change mode of the document.

* Co-ordination group for Mutual recognition and Decentralised procedures - human (CMDh)