This guidance document is an annex to the parent guidance VICH GL3, “Stability Testing of New Veterinary Drug Substances and Medicinal Products.” It addresses the recommendations for stability testing of new veterinary medicinal Medicated Premix products intended for submission for approval to the European Union, Japan and the United States. The parent guidance (VICH GL3) provides a general indication of the information on product stability generated, but the annex for Medicated Premixes leaves sufficient flexibility to encompass a variety of different practical and scientific considerations that are specific to the characteristics of the drug products being evaluated. Other stability studies which might be important to consider like stability in relation to conditioning and pelleting, segregation and homogeneity studies are not within the scope of this guidance.
The guidance primarily addresses the generation of acceptable stability information for submission in Registration Applications for medicated premix drug products containing new molecular entities. Medicated Premixes are intended for oral administration following incorporation into animal feed. The guidance only pertains to Medicated Premixes, and does not currently seek to cover information required for products manufactured from medicated premixes. Stability studies carried out with a medicated premix should be in line with the parent guidance. However, the application of the parent guidance may be limited in some instances. This guidance therefore describes those areas where there may be differences in the stability data package for medicated premixes.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.