Consultation on the Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs

It is proposed that this draft guidance document will replace the 1998 policy, Change in Manufacturer’s / Product Name Policy (CMPN), which governs the administrative processing of drug submissions and applications. The proposed new guidance document clarifies the requirements for eligible drug submissions and applications under the administrative pathway.

How to Get Involved

This consultation is open for a 60-day comment period starting February 17, 2017 until April 18, 2017.

Please select and read through the link below titled “consultation document”. Once read please submit your comments via email, fax or by mail to:

Health Canada
Health Products and Food Branch, Therapeutic Products Directorate
Bureau of Policy, Science and International Programs
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott St.
Ottawa, Ontario
K1A 0K9

Telephone: 613-957-1058

For your convenience, please find attached a template for your comments.

Interested parties are encouraged to provide comments by April 18, 2017.

Reporting to Canadians

A summary of the results from the consultation will be made available.

If you have any questions, contact us at Bureau of Policy, Science and International Programs.

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