Food and Drug Regulations - Project # 1663 - Schedule F Amendment

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 this Notice of Intent (NOI) is to provide an opportunity to comment on a proposal to add to Part I of Schedule F to the Food and Drug Regulations pancrelipase, pancreatin and pancreatic extracts where the strength per dosage unit exceeds 20,000 USP units of lipase activity or when indicated for the treatment of pancreatic exocrine insufficiency. The proposed addition to Schedule F means that all products that contain pancrelipase, pancreatin or pancreatic extracts where the strength per dosage unit exceeds 20,000 USP units of lipase activity or when indicated for the treatment of pancreatic exocrine insufficiency would require a prescription to be sold.

How to Get Involved

This consultation is open for comment starting February 13, 2012 until April 30, 2012. 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: 1663
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 April 30, 2012.

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.