to the same method or process or material) at the same time or in cases of a major update of the quality information for the active substance or the Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations EMA/CMDv/7381/20. [...] In all cases where the change impacts on the contents of the dossier the variation application should include amendment of the relevant section(s) of the dossier. [...] In such cases the changes should be clearly identified in the application form as editorial changes and a declaration that the content of the concerned part of the dossier has not been changed by the editorial changes beyond the scope of the variation submitted should be provided. [...] The level of testing performed by the finished product manufacturer on receipt of batches of the drug substance is considered to be a GMP issue and therefore information on whether the finished product manufacturer performs all of the tests listed in the approved specifications or accepts some of the results based on the certificate of analysis provided by the drug substance manufacturer should no. [...] II.d.1 Change in the specification parameters and/or Documentation to be Timetable limits of the finished product supplied a) Change outside the approved specifications limits S range b) Deletion of a specification parameter which may S have a significant effect on the overall quality of the finished product Guidance on the details of the classification of variations requiring assessment according.
Authors
- Pages
- 43
- Published in
- Malta
Table of Contents
- 1. Introduction 3
- 2. Scope 3
- 3. Legal basis 4
- 4. Definitions 4
- 5. Types of variations 4
- 6. Variations arising from those listed in Commission Implementing Regulation (EU) 2021/17 which do not meet the requirements laid down therein 4
- 7. Classification of additional, new variations not already listed 5
- 8. Timetables for variation procedures 5
- 9. Explanation of the Annex to this guidance 6
- 10. References 7
- 11. Annex 9
- F.I ACTIVE SUBSTANCE 11
- F.I.a) Manufacture 11
- F.I.b) Control of active substance 13
- F.I.c) Container closure system 15
- F.I.d) Stability 16
- F.I.e) Design Space and post-approval change management protocols 17
- F.I.f) Other changes to the active substance 18
- F.II. FINISHED PRODUCT 19
- F.II.a) Description and composition 19
- F.II.b) Manufacture 21
- F.II.c) Control of excipients 26
- F.II.d) Control of finished product 27
- F.II.e) Container closure system 29
- F.II.f) Stability 31
- F.II.g) Design Space and post approval change management protocol 32
- F.III CEP/TSE/MONOGRAPHS 33
- F.IV DEVICES 35
- F.V. CHANGES TO A MARKETING AUTHORISATION RESULTING FROM OTHER REGULATORY PROCEDURES 36
- F.V.a) VAMF/PTMF 36
- F.V.b) Harmonisation of the quality dossier 36
