Stability testing for applications for variations to marketing authorisation - Scientific guideline
HumanVeterinaryScientific guidelines
This guideline applies to human and veterinary medicines.
This document provides general guidance on the stability data which have to be generated in order to support a variation to a marketing authorisation. It provides general guidance on stability testing for type IA and type IB variations and addresses the data requirements for common type II variations.
Keywords: Stability, stability testing, stability data, chemical active substance, specification, variation
Current effective version
Guideline on stability testing for applications for variations to a marketing authorisation - Revision 2
AdoptedReference Number: EMA/CHMP/CVMP/QWP/441071/2011- Rev.2
English (EN) (166.62 KB - PDF)
First published: Last updated:
Document history - Revision 2
Guideline on stability testing for applications for variations to a marketing authorisation - Revision 2
AdoptedReference Number: EMA/CHMP/CVMP/QWP/441071/2011- Rev.2
English (EN) (166.62 KB - PDF)
First published: Last updated:
Overview of comments received on 'Guideline on stability testing for applications for variations to a marketing authorisation' - Revision 2
Reference Number: EMA/CHMP/CVMP/QWP/774027/2013 Rev. 1
English (EN) (1.61 MB - PDF)
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Draft guideline on stability testing for applications for variations to a marketing authorisation - Revision 2
Consultation dates:
to Draft: consultation closedReference Number: EMA/CHMP/CVMP/QWP/441071/2011Summary:
The following guideline provides guidance on the stability data which have to be generated in order to support a variation to a Marketing Authorisation. The guideline provides general guidance on stability testing in case of type I (A and B) variations and addresses the data requirements for widely encountered cases of type II variations.
English (EN) (122.91 KB - PDF)
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Concept Paper on the Need for Revision of the Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation
Consultation dates:
to Draft: consultation closedReference Number: EMA/63033/2010
English (EN) (71.76 KB - PDF)
First published: Last updated:
Document history - Revision 1
Guideline on stability testing for applications for variations to a marketing authorisation - Revision 1
AdoptedLegal effective date: Reference Number: CPMP/QWP/576/96 Rev 1
English (EN) (159.21 KB - PDF)
First published: Last updated:
Related content for human medicines
- Quality: stability
- Directive 2001/83/EC
- Commission Regulation (EC) No 1234/2008
- Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures
- ICH Q1A (R2) Stability testing of new drug substances and drug products
- ICH Q1E Evaluation of stability data
- ICH Q1D Bracketing and matrixing designs for stability testing of drug substances and drug products
- In-use stability testing of human medicinal products
- Maximum shelf-life for sterile products for human use after first opening or following reconstitution
- Quality of herbal medicinal products/traditional herbal medicinal products
- Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products
- Stability testing of existing active ingredients and related finished products
Related content for veterinary medicines
- Quality: non-immunologicals
- Directive 2001/ 82/EC
- Commission Regulation (EC) No 1234/2008
- Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures
- In-use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products)
- Maximum shelf-life for sterile medicinal products after first opening or following reconstitution
- Quality of herbal medicinal products/traditional herbal medicinal products
- Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products
- Stability testing of existing active substances and related finished products
- VICH GL3 Stability testing of new veterinary drug substances and medicinal products
- VICH GL45 Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products
- VICH GL51 Quality: statistical evaluation of stability data