Consultation on the Atypical Active Pharmaceutical Ingredients List
Notice to the reader:The online consultation is now closed.
Health Canada invites you to provide comments on the list of atypical Active Pharmaceutical Ingredients (APIs). Health Canada considers certain APIs that are of lower risk and widely used outside of the pharmaceutical industry as atypical APIs. The listed APIs are used as pharmaceutical excipients, or as ingredients in natural health products (NHP), foods, cosmetics and meet recognised standards other than Good Manufacturing Practices (GMP).
Importers of the listed atypical APIs and finished dosage form importers of products formulated using listed atypical APIs, which are manufactured against standards other than GMP, 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 consultation is looking for comments from:
- health professionals
- all others interested parties
Comments are requested on:
In order for Health Canada to consider proposals for inclusion or exclusion of a specific ingredient on the List of Atypical APIs, a rationale should be provided.
What does this mean for industry?
This approach is expected to offer importers of the listed atypical APIs and finished dosage form importers of products formulated using listed atypical APIs, more flexibility in using APIs manufactured against a standard other than GMP.
When and where
The list of ingredients will be available online between December 2, 2016 and January 15, 2017.
How to participate
You may submit your comments on the list of ingredients by:
- email, in electronic files such as:
- Microsoft Word
- Adobe Acrobat
We will review and consider all comments received by January 15, 2017.
Health Product Inspection & Licensing
Health Product Compliance Directorate
200 Eglantine Driveway
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