This Question and Answer page is developed and maintained by the joint CHMP/CVMP Quality Working Party (QWP), and addresses a number of questions that have been brought to the attention of QWP by Marketing Authorisation Holders (MAHs) and/or EEA Competent Authorities, on matters related to quality of medicinal products.
It provides the EEA harmonised position on issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures.
If a question is not addressed in this document, Marketing Authorisation Holders are encouraged to contact the European Medicines Agency for further information.
Please note that this document has been produced to provide clarification and/or additional information, and should be read in conjunction with the European Pharmacopoeia, quality guidelines and other guidance documents.
How useful is this page?
Average rating:Based on 50 ratings
Add your rating:
- See all ratings
17 ratings0 ratings8 ratings4 ratings21 ratings
- Q&A on ICH Q8, Q9 and Q10
- Q&A in relation to the submission of quality related variations according to Regulation 1084/2003 have been published by the Heads of Agencies' Mutual Recognition Facilitation Group. The scientific principles are also relevant to centrally authorised products.
- ICH: M 4 Q: Location issues for common technical document for the registration of pharmaceuticals for human use - Quality questions and answers - Step 5
- Q&A on glycerol contamination with Diethylene Glycol in relation to Annex 8 of the GMP Guide
Send all queries regarding this content to: email@example.com