Additional data guidelines for chemistry and manufacture (Part 2)

These pages contain information about the range of chemistry and manufacture (Part 2) data that the APVMA recommends submitting as part of your application.

We have adopted (with some conditions) 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.

Chemistry and manufacture guidelines for veterinary chemical products

Chemistry and manufacture guidelines for veterinary chemical products include the following:

VICH guidelines

Other guidelines

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

Related guidelines

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