Notice Regarding Dear Health Care Professional Letters for Notice of Compliance with Conditions

April 15, 2016
Our file number: 16-103332-889

This Notice serves to solicit feedback from sponsors of submissions that qualify under the Notice of Compliance with Conditions (NOC/c) policy, on a proposed change in process whereby the "Dear Health Care Professional Letter" would no longer be required. In place of the Letter, a notice highlighting the conditional market authorization of the health product would be communicated through Health Canada's Health Product InfoWatch and would be posted on Health Canada's website. This proposed change reflects Health Canada's streamlined approach to risk communications, and recognizes that all relevant information is available to healthcare professionals and the general public through the Product Monograph, the Regulatory Decision Summary, and the Summary Basis of Decision which are posted on the Health Canada website.

The Health Product InfoWatch notice ["NOTICE OF MARKET AUTHORIZATION WITH CONDITIONS" - (see appendix I)] will include the brand name and proper name of the drug, its dosage form, strength and indication, as well as a prominent disclosure of the nature of authorization granted and the need to communicate this to patients. Relevant links to the Product Monograph and sponsor contact will also be included. The Health Product InfoWatch will be posted on Health Canada's website, and disseminated to key health care groups.

The Health Product InfoWatch is a monthly publication that intends to raise awareness and provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. Each publication includes a monthly recap of health product advisories and summary safety reviews, as well as a selection of new health product safety information. Please note that since the Health Product InfoWatch is a monthly publication, the Health Product InfoWatch notice ("NOTICE OF MARKET AUTHORIZATION WITH CONDITIONS") would be published in the month immediately following issuance of the NOC/c.

The Health Product InfoWatch notice would be completed by Health Canada. Sponsors would be notified 24 hours in advance of publication.

The relevant sections of Health Canada's guidance document, Notice of Compliance with Conditions, would be revised to reflect this change in process.

Comments on this notice should be submitted within 60 calendar days to the contact below:

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

Appendix I - Template for Health Product InfoWatch Section "NOTICE OF MARKET AUTHORIZATION WITH CONDITIONS"

NOTICE OF MARKET AUTHORIZATION WITH CONDITIONS

A Notice of Compliance with Conditions (NOC/c) is a form of market authorization with conditions granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Communicating a NOC/c is intended to raise awareness on the details of the drug and the nature of authorization granted.

Healthcare professionals are encouraged to report to Health Canada any adverse reactions suspected of being associated with marketed health products, including drugs authorized under the NOC/c policy.

AUTHORIZATION WITH CONDITIONS OF <DRUG NAME>

Health Canada has issued a Notice of Compliance with Conditions under the Notice of Compliance with Conditions (NOC/c) policy for <Brand name (Proper name)>, <dosage forms and strength>, for <indication(s)>. Patients should be advised of the nature of the product authorization.

For the complete prescribing information and information available for the patients/caregivers, please consult the <Brand Name> Canadian Product Monograph (CPM). The CPM can be accessed through: <website URL> or by request by contacting <Company Name> at <toll free number>. Contact the company for a copy of any references, attachments or enclosures.

All Notices of Compliance with conditions (NOC/c) are included in the following listing on the Health Canada website.