Notice - Health Canada to stop sending Validation Reports for passed submissions

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Contact: eReview

September 9, 2011

Notice

Our file number: 11-116642-143

Health Canada to stop sending Validation Reports for passed submissions

Health Canada uses the LORENZ eValidator™ for the validation of submissions in both the Electronic Common Technical Document (eCTD) and non-eCTD format. It is a stand alone application that verifies and validates submissions based on configured check options and verification rules set in accordance to specified Document Type Definitions (DTDs) and various requirements published by the International Conference on Harmonization and other authorities. The result of the validation is a structured report listing the analyzed items.

As of October 1, 2011, Health Canada will no longer be providing the Validation Reports or email notifications for submissions that have passed validation. Any submissions that have warnings or fails validation will still have a validation report sent to the sponsor.

Although the software and profile may be updated without further notice, the current version used by Health Canada is:

• Software: docuBridge^® eCTD Validator 3.0 SP1
• Profile: eCTD Validator - Profile HC-SC-2-4

If you have any questions regarding the content of this notice, please contact:

Submission and Information Policy Division (SIPD)
Therapeutic Products Directorate
Health Canada
Finance Building 2,
Address Locator 0201A1
101 Tunney's Pasture Driveway
Ottawa, Ontario
K1A 0K9

Email: ereview@hc-sc.gc.ca
Telephone: 613-957-3123
Fax: 613-941-0825