Food and Drug Regulations - Project # 1470 - Non-Medicinal Ingredient (NMI) Formulation

The online consultation is now closed. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period.

The purpose of the proposed regulatory amendment would be to allow Health Canada's assessment of Division 1 drugs to consider the risks associated with their Non-medicinal Ingredients (NMIs) at the premarket and post-market stages, in order to improve the safety of products available to Canadians.

Health Canada generally does not receive a complete quantitative list of NMIs for Division 1 drugs, unless voluntarily provided by the manufacturer of the drug. Therefore, if a health risk to Canadians is posed by a specific NMI, Health Canada is limited in its capacity to develop risk management strategies since it would be challenging to identify the Division 1 drugs on the market which contain the ingredient in question.

How to Get Involved

This consultation is open for comment starting October 17, 2011 until December 30, 2011. Please select and read through the link below titled "consultation document". Once read please submit your comments via email, fax or by mail to:

regaff-affreg@hc-sc.gc.ca

Refer to Project Number: 1470
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street, Holland Cross
Tower 'B', Second Floor
Address Locator: 3102C5
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Facsimile: 613-941-6458

Consultation Document

Interested parties are encouraged to provide comments and suggestions by December 30, 2011.

Reporting to Canadians

Health Canada will make the results of this consultation available on this website.

If you have any questions, contact us at Regulatory Affairs.