Q&A Document on the QP Declaration revised
Recommendation
12/13 November 2024
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)
Related GMP News
02.10.2024MHRA: New Rules for Manufacturers and Wholesalers after Brexit
24.09.2024What is RCA (Root Cause Analysis)?
18.09.2024Lack of GMP Training and related Documentation: What Deviations can be found in FDA Warning Letters?
04.09.2024Switzerland: Changes for the Qualification of QPs (Responsible Person; RP in Switzerland)
04.09.2024Insufficient Root Cause Analysis leads to FDA Warning Letter
28.08.2024Switzerland to implement Measures to combat Shortages of Medicines