Q&A Document on the QP Declaration revised
Recommendation
26/27 November 2026
Barcelona, Spain
With Pre-Conference Sessions on 25 November 2026
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
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)
Related GMP News
21.10.2026Switzerland: GMP Compliance by Foreign Manufacturers
14.10.2026EU Pharma Package: Council Adopts New Rules
14.10.2026ICH Publishes New Training Material for Quality Guidelines
14.10.2026WHO issues Draft Guidance on Quality Risk Management
26.08.2026GMP and "Planned Deviations" - a Contradiction?
19.08.2026Why Root Cause Analysis is the Key to efficient CAPA