Notice - Canadian Module 1 Schema Version 2.2 (extension of deadline)

February 11th, 2013

Notice

Our file number: 13-101547-719

Re: The Canadian Module 1 Schema Version 2.2

Health Canada is pleased announce an extension of the deadline for using the old Canadian Module 1 DTD Version 1.0 to build electronic Common Technical Document (eCTD) regulatory activities. Accepting eCTD regulatory activities built using the revised schema (version 2.2) has been implemented by Health Canada since September 2012. In response to sponsors' requests and to provide an opportunity for all sponsors to obtain the required updated applications to build eCTDs using the Canadian Module 1 Schema Version 2.2, Health Canada has extended the deadline until September 30th, 2013.

The finalized Canadian Module 1 Schema Version 2.2 replaces the 2004 Canadian DTD Version 1.0. Health Canada implementation and deadlines are as per the following schedule:

  • as of September 30th, 2013, Health Canada will no longer be accepting regulatory activities built using the old Canadian Module 1 DTD Version 1.0.
  • since September 30th, 2012, Health Canada has been accepting regulatory activities built using the revised Canadian Module 1 Schema Version 2.2.

Questions and comments relating to this notice should be submitted, preferably in electronic format to:

Office of Submissions and Intellectual Property (OSIP)
Therapeutic Products Directorate
Health Canada
Address Locator 0201A1
101 Tunney's Pasture Driveway
Ottawa, Ontario
K1A 0K9

Telephone: 613-941-7281
Fax: 613-941-0825
Email: eReview@hc-sc.gc.ca

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