Q&A Document on the QP Declaration revised
Recommendation
10/11 September 2025
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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)
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