Consultation on the List of Atypical Active Pharmaceutical Ingredients for Veterinary Use - Closed consultation

Health Canada invited participants to provide comments on the list of Atypical Active Pharmaceutical Ingredients (APIs) for veterinary use. Health Canada considers certain APIs that are of lower risk and widely used outside of the pharmaceutical industry as atypical APIs. This was consistent with the approach that was taken for the implementation of the establishment licensing requirements for APIs for human use.

These APIs, considered as atypical APIs, and on the List of Atypical APIs for veterinary use, are currently used as pharmaceutical excipients, or as ingredients in natural health products (NHPs), Veterinary Health products (VHPs), as well as foods, and meet recognized standards other than Good Manufacturing Practices (GMP).

The List of Atypical APIs for human use applies to veterinary drugs. Health Canada had proposed to expand this list to include certain APIs for veterinary use.

Who was the focus of this consultation

We engaged with:

• animal health industry
• veterinary health professionals
• all other interested parties

Goals of the consultation

The goal of the consultation was to get feedback on the List of Atypical APIs for veterinary use.

Importers of these APIs and finished dosage form importers of products formulated using these APIs may experience challenges in obtaining GMP evidence due to the nature and the design of the manufacturing processes and the international classification for these ingredients.

This List is expected to offer importers of these atypical APIs and finished dosage form importers of products formulated using these atypical APIs, more flexibility in using APIs manufactured against a standard other than GMP.

Key questions for discussion

Do you have comments on the List of Atypical APIs for veterinary use?

The input that was gathered through this process will be used to update the List of Atypical Active Pharmaceutical Ingredients for Veterinary Use.

Related information

• Notice to Stakeholders – Implementation of Establishment Licensing Requirements for Atypical Active Pharmaceutical Ingredients for Veterinary Use

Contact us

• Health Product Inspection & Licensing
  Health Product Compliance Directorate
  Health Canada
  200 Eglantine Driveway
  Ottawa, Ontario
  K1A 0K9
• Email: hc.api.questions-ipa.sc@canada.ca