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Therapeutic Products Directorate
The purpose of this policy is to define the conditions and procedures for the administrative processing of drug submissions pertaining to a change in manufacturer's name and/or product name following a merger, buy-out or other corporate restructuring or as a result of a licensing agreement.
If a manufacturer's name for a drug product and/or the product name changes subsequent to a merger, buy-out or other corporate restructuring or as a result of a licensing agreement, Section C.01.014.1 of the Food and Drug Regulations requires that a submission for a Drug Identification Number (DIN) be submitted. For new drugs, a New Drug Submission (NDS) is required. Section C.01.014.03 of the Regulations, requires manufacturers to notify the Therapeutic Products Directorate (TPD) within 30 days of the commencement of sale of a drug product.
New data requirements for DIN submissions were first issued by the TPP in September 1994. The gap between these and former DIN submission requirements is considered to be bridged by the knowledge gained from Canadian market experience for products that received a DIN and were marketed (notified) prior to September 1994. This same knowledge and experience has not been gained on drug products for which DINs were issued but were not notified for sale before this date.
All manufacturers holding a DIN issued prior to September 1994 for a product that has not been notified must submit to the TPD for review, the data necessary to meet current requirements under the DIN Submission GuidelineFootnote 1 should they wish to make any changes to the product and/or begin to market the product. Manufacturers must not market the product until they are advised of the outcome of the review. The TPD will advise the manufacturer upon the completion of the review if the DIN for that product remains valid. If the DIN remains valid, the manufacturer may then market the product and notify the product for sale with the TPD within 30 days.
This policy applies to eligible drug submissions submitted to the TPD for administrative processing as a result of a change in the manufacturer's name and/or product name subsequent to a merger, buy-out or other corporate restructuring or the establishment of a licensing agreement.
This policy replaces the current policy: Therapeutic Products Directorate Policy Issues: Changes in Manufacturer's Name, January 18, 1996 (960118.ext).
Licensing Agreement: an agreement between two firms whereby one firm supplies a drug product to another firm for sale under the second firm's name.
If a manufacturer's name changesFootnote 2 and/or the product name for a drug product changes, a DIN Submission for each affected drug product must be submitted to the TPD. For new drugs, a New Drug Submission is required to be submitted.
All aspects of the drug product, including the conditions of manufacture and sale must be identical to those previously authorized for that product except for:
In the case of a product name change, the submission for the proposed name change must not make a claim that conflicts with the conditions of the previously issued DIN or Notice of Compliance (NOC).
The New Drug Submission must be cross-referenced to the previous submission for that drug product for which a NOC was issued.
The DIN Submission must be cross-referenced to the previous submission for that drug product. The product must be currently marketed (notified) in Canada.Footnote 3
For information on issues related to Submission Evaluation Fees and annual Authority to Sell Fees, please refer respectively to current versions of the Guidance Document on Cost Recovery; Submission Evaluation Fees and to the Authority to Sell Drug Fees, Fee Reduction and Adjustment Request guideline.Footnote 6
This policy is effective as of March 24, 1998.
1. Nature of Change
(please check one)
2. Reason for Change
(Please check one) (Please check one)
We certify that all aspects of the submission pertaining to:
are identical to:
submission(s) except for a change in the manufacturer/sponsor's name and/or product name and that the product will be manufactured in the same location with identical specifications and procedures.
Drugs Directorate Guidelines: Preparation of Drug Identification Number Submissions, February 22, 1995.
Only substantive changes to the manufacturer's name are required to comply with the requirements stated in this policy. Notice of non-substantive name changes, e.g., the addition of "a Division of..." , "Inc" or "Ltd" following a manufacturer's name, should be submitted in writing to the Submission and Information Policy Division of the Therapeutic Products Directorate.
DIN Submissions which cross-reference a previous submission for a drug product which is not marketed (not notified) will be subject to a full review.
Posted on the TPD WebSite under the Forms heading
Policy Issues from the Therapeutic Products Directorate, Management of Drug Submissions, August 25, 1997
Posted on the TPD WebSite under the cost recovery heading