Notice - Content changes to Notices of Compliance issued for administrative submissions

March 19, 2013

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Notice

Our file number: 13-103540-623

Re: Content changes to Notices of Compliance issued for administrative submissions

In an effort to align with the Department's commitment to enhance the transparency and openness of the drug approval process by making authorised, high quality and up-to-date drug information available to Canadians, Health Canada would like to announce its intention to modify the content of the Notices of Compliance (NOCs) issued to companies for submissions that are administrative. Several key pieces of information will be added to the NOC in an effort to increase clarity and transparency.

Currently, NOCs issued for administrative submissions do not clearly indicate the reason for submission. This may cause confusion for internal and external stakeholders when trying to identify the nature of the underlying submission, and the reason for NOC issuance. Therefore, Health Canada intends to clarify administrative NOCs by adding the word "Administrative" on the paper NOC under "Reason for Submission", followed by the reason for the change. For example, if a sponsor files an administrative submission as a result of a licensing agreement between two firms, the NOC will indicate, under the Reason for Submission section, "Administrative - Licensing Agreement between two companies". A further non-exhaustive list of examples for several different types of administrative changes is included below:

• Administrative - Manufacturer Name Change
• Administrative - Product Name Change
• Administrative - Additional Product Name
• Administrative - Licensing Agreement between two companies
• Administrative - Transfer of Drug Identification Number (DIN) Holder
• Administrative - Merger/Buyout

In addition to these changes, Health Canada intends to update the NOC Database Online. The "Submission Class" field will display the word "Admin" to indicate those submissions which are administrative. Moreover, enabling this functionality will allow users to query and view results specific to administrative submissions.

Furthermore, the "Notice of Compliance Information" page on the NOC Database Online will contain new information under "Reason for Submission" which will provide details on the nature of administrative submissions in accordance with the proposed changes and examples mentioned above.

Submissions filed on or after May 13, 2013, will be subject to these changes. Changes to the NOC Database Online will follow in the near future. Should you have any questions, please feel free to direct them to SIPDmail@hc-sc.gc.ca.