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POLICY
Therapeutic Products Directorate

Changes in Manufacturer's Name and/or Product Name

1. Purpose

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.

2. Background

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 Guideline 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.

¹ Drugs Directorate Guidelines: Preparation of Drug Identification Number Submissions, February 22, 1995.

3. Scope

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).

4. Definitions

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.

5. Policy Statement

If a manufacturer's name changes⁽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:

1. the manufacturer's name, and/ or
2. the product name

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.⁽³⁾

² 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.

³ 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.

6. Responsibilities & Procedures

1. Manufacturers must submit to the Submission and Information Policy Division of the TPD the following documentation:
   
   
   • a signed Certification Form (see: Appendix 1) for each drug product, certifying that all aspects of the product and labelling material will remain the same except for the name change(s) in the labelling material and/or Product Monograph;
     
     
   • a completed Drug Submission Application form⁴;
     
     
   • labelling material bearing the new name of the manufacturer and/or product name.
     
     
   • a completed Submission Fee Application Form; and
     
     
   • for new drugs only, copy of the Product Monograph is also required.
     
     
2. Merger/Buy-out
   
   In addition to the documentation listed in 6 a), manufacturers must:
   
   
   • provide written confirmation of the changed business circumstance from the original DIN owner with authorization to access the cross-referenced submission; and
     
     
   • provide written notification concerning whether they prefer to have the current DIN for that drug product reassigned to the new manufacturer's name and/or product name or whether they wish to have a new DIN assigned to that product.
     
     
   Licensing Agreement
   
   In addition to the documentation listed in 6 a), manufacturer's must:
   
   
   • provide written authorization from the original DIN owner to access the cross-referenced submission and indicate whether or not the original DIN owner intends to continue to market the product; and
     
     
   • if the original DIN owner is ceasing to market the product, provide written notification concerning whether they prefer to have the current DIN for that drug product reassigned to the new licensed manufacturer's name and/or product name or whether they wish to have a new DIN assigned to that product.
     
     
3. Submissions will be processed and reviewed by the TPD in accordance to the provisions and timeframes outlined in the Management of Drug Submissions Policy ⁵. Following a positive review of the application, the TPP will make the necessary administrative changes to the DIN number for the drug product.
   
   Manufacturers applying for a DIN for a drug product as a result of a licensing agreement will be assigned a new DIN under the licensed manufacturer's name / product name in cases where the original DIN owner company intends to continue to market the product under its own name.
   
   
4. Manufacturers must notify the TPD within 30 days of the commencement of sale of the drug product under the new manufacturer's name and/or product name.
   
   
5. Manufacturers must inform the TPD when the drug product marketed under the manufacturer's former name is no longer sold. Manufacturers are responsible for the drug product even if the DIN has been discontinued but continues to be available in the marketplace.

⁴ Posted on the TPD WebSite under the Forms heading
(www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt)

⁵ Policy Issues from the Therapeutic Products Directorate, Management of Drug Submissions, August 25, 1997.

7. Fees

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.⁶

⁶ Posted on the TPD WebSite under the cost recovery heading
(www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt).

8. Effective Date

This policy is effective as of March 24, 1998.

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Appendix 1:

Changes in Manufacturer's Name and/or Product Name

Administrative Changes - Certification Form

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1. Nature of Change
(please check one)

Change in Manufacturer's Name

Change in Product Name

Change in Manufacturer's Name and Product Name

2. Reason for Change
(Please check one)(Please check one)

  Product name change onlyNew DIN..... Same DIN.....

 Merger/Buy-out
Same DIN may be retainedNew DIN..... Same DIN.....

  Licensing agreement
(original DIN owner to cease sale of product).
Same Din may be retained by second firm New DIN..... Same DIN.....

  Licensing agreement
(2firms to market the same product).
New DIN will be issued to the second firm New DIN..... Same DIN.....

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We certify that all aspects of the submission pertaining to:

(name of the product)

submitted by:

(name of the manufacturer)

are identical to:

(Name of product, name of manufacturer)


(current DIN)

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.

Name of Authorized Signing Official


Date


Title / Company


Tel. No.