Notice - Annual Drug Notification package is now being sent electronically

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July 31, 2012

Our file Number: 12-113854-411

Annual Drug Notification package is now being sent electronically

As per the notice sent to all marketed Drug Identification Number (DIN) holders on May 4, 2012, Health Canada would like to remind sponsors that the Annual Drug Notification package is now being sent electronically.

The Annual Drug Notification Form (ADNF) is intended to assist you in complying with the Food and Drug Regulations (section C.01.014.5) which requires that owners of a DIN confirm annually before October that all information previously supplied with regard to the product is correct. Failure to comply may result in cancellation of existing DINs by Health Canada (section C.01.014.6.2.(a)).

The Submission and information Policy Division (SIPD) is responsible for preparing and distributing packages for the Annual Drug Notification process to all marketed DIN holders. In the past, one hard copy package was prepared and mailed to each company (marketed DIN Holder/Agent/Broker) every year. In order to increase efficiency, the manual process of mailing these packages has been replaced with an automated solution. As a result:

• the Information package and the Annual Drug Notification Form (PDF documents) have been sent as e-mail attachments to each company on June 4, 2012.

Please note that the content of the Annual Drug Notification package and the process to return the ADNF has NOT changed. Sponsors are being asked to return the ADNF by August 3, 2012 by mail, fax or e-mail.

Any questions or comments regarding the content of this Notice should be sent to the contact listed below.

Health Canada
Health Products and Food Branch, Therapeutic Products Directorate
Submission and Information Policy Division
1st Floor, Finance Building
101 Tunney's Pasture Driveway
Address Locator 0201A1
Ottawa, ON K1A 0K9

Telephone: 613-946-1151
E-mail: SIPDANNUAL_ANNUELLEDPPR@hc-sc.gc.ca