Additional data guidelines for chemistry and manufacture (Part 2)

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has adopted a number of VICH guidelines that outline the procedures recommended for generating relevant chemistry and manufacture data for your application.

Applicants should refer to these guidelines, in conjunction with the general guidelines for chemistry and manufacture of active constituents and products, when generating chemistry and manufacture data?or preparing chemistry data dossiers for submission.

Chemistry and manufacture guidelines for veterinary chemical products

VICH guidelines

Other guidelines

The FDA, EMA and Heath Canada websites also provide guidance which may be useful when generating chemistry and manufacture data.

Related guidelines

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