Notice - Clarification to brand name changes being made following the Guidance Document: Fees for the Review of Drug Submissions and Applications

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October 27^th, 2011

Notice

Our file number: 11-119960-308

Re: Clarification to brand name changes being made following the Guidance Document: Fees for the Review of Drug Submissions and Applications

Health Canada would like to inform sponsors that drug submissions for brand name changes to their product which require a brand name assessment and/or Look-alike Sound-alike (LA/SA) assessment will no longer be acceptable for processing as an administrative drug submission pursuant to the Policy "Changes in Manufacturer's Name and/or Product Name". Under the current policy, changes to a manufacturer and/or brand name are handled on an administrative basis without the need for review, assuming all aspects of the drug product label, including claim and label text, are identical to the previously issued drug product label. As such, the above-noted policy was not meant to handle brand name changes that require an assessment. Health Canada is currently reviewing and considering revisions to this policy.

According to the "Guidance Document: Fees for the Review of Drug Submissions and Applications", any submission that requires a scientific review to support a name change for the drug product is not considered administrative and should be submitted for processing as a Labelling Only submission. Simple brand name changes that do not require an assessment, for example where a prefix or suffix is being added, removed, or changed, continue to be eligible for processing as administrative drug submissions.

Should you have any questions or comments regarding the content of the Notice, please contact:

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

Telephone: (613) 957-3123
Fax: (613) 941-0825
E-Mail: SIPDmail@hc-sc.gc.ca