Notice - Release of the Final Guidance Document: Notice of Compliance with Conditions (NOC/c)

September 16, 2016
Our file number: 16-109820-191

Health Canada is pleased to announce the release of the final revised Guidance Document: Notice of Compliance with Conditions (NOC/c). This guidance document includes text to replace the Dear Healthcare Professional Letter with the "Notice of Market Authorization with Conditions, as outlined in the April 1, 2016 notice that was posted on the Health Canada website for a 60-day consultation.

In addition, a few administrative edits were made to this final version of the guidance document (that is, including the term "Patient Medication Section" with "Consumer Information Section" throughout the guidance document).

Comments received from the April 15, 2016 consultation on the Notice Regarding Dear Health Care Professional Letters for Notice of Compliance with Conditions were reviewed and considered in the finalization of this document.

All revisions to this guidance document are effective immediately.

Questions or comments related to the guidance should be directed to:

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

Telephone: 613-957-6451
Fax: 613-941-1812
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca