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This document specifies requirements for the design, conduct, and evaluation of bioequivalence studies for pharmaceutical forms with systemic action. It also explains how in-vitro data in specific cases may be used to allow bridging of safety and efficacy data.
Keywords: Bioequivalence, pharmacokinetics, generic veterinary medicinal product, predefined acceptance criteria, biowaiver, in vitro dissolution tests
Current version - effective from 28/01/2022
Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 4
English (EN) (458.95 KB - PDF)
Document history
Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3
Guideline on the conduct of bioequivalence studies for veterinary medicinal products
English (EN) (429.46 KB - PDF)
Overview of comments received on 'Guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMA/CVMP/016/00-Rev.3) - Revision 3
Overview of comments received on 'Guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMA/CVMP/016/00-Rev.3) - Revision 3
English (EN) (101.82 KB - PDF)
Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3
English (EN) (334.49 KB - PDF)
Concept paper for the revision of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3
The current CVMP guideline for the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2) was first adopted in January 2001 and revised in April 2011.
English (EN) (96.14 KB - PDF)
Guideline for the conduct of bioequivalence studies for veterinary medicinal products - Revision 2
English (EN) (297.34 KB - PDF)
Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 2
English (EN) (276.72 KB - PDF)
Overview of comments received on guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMEA/CVMP/016/00-Rev.2-CONSULTATION) - Revision 2
English (EN) (470.92 KB - PDF)
Concept paper on the revision of the guideline for the conduct of bioequivalence studies for veterinary medicinal products (EMEA/CVMP/016/00) - Revision 2
English (EN) (35.18 KB - PDF)
Guideline for the conduct of bioequivalence studies for veterinary medicinal products - Revision 1
English (EN) (83.47 KB - PDF)
Overview of comments received on draft guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 1
Overview of comments received on draft guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 1
English (EN) (680.65 KB - PDF)
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