Assignment of Drug Identification Numbers (DINs) According to Product Name

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POLICY
From the Therapeutic Products Programme

Issued: April 14, 1998
Updated: November 3, 2000

Therapeutic Products Programme
Tunney's Pasture
A.L.# 0702A
OTTAWA (Ontario) K1A 0L2

April 14, 1998

Subject: "ASSIGNMENT OF DRUG IDENTIFICATION NUMBERS (DINs) ACCORDING TO PRODUCT NAME"

The purpose of this policy is to define how the assignment of drug identification numbers (DINs) will be issued to applicants who may, or may not, wish to identify a distributor or retail outlet on the label as part of the brand name.

The enclosed Therapeutic Products Programme policy is the revised version of the current policy entitled: "Assignment of DINs for Private Label Products", dated January 18, 1996. In addition to some editorial changes, the major change is the removal of the words "private label", to which we received numerous comments and complaints. The revised policy provides clarification and expanded guidance on when and how DINs are assigned for these types of products.

This policy will be posted on the Internet and will be available by accessing the Therapeutic Products Programme Website address at
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/index-eng.php. The pathway will be,
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/
zip/prodpharma/din_ind_pol_e.zip

Original signed by

Dann M. Michols
Director General

Enclosure cc : PMC / CGP

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Assignment of Drug Identification Numbers (DINs) According to Product Name

Purpose:

The purpose of this policy is to define the options available for the assignment of Drug Identification Numbers (DINs) to applicants who may, or may not, wish to identify a distributor or retail outlet on the label as part of the brand name.

This policy replaces the Drugs Directorate Policy of January 18, 1996 entitled:
"ASSIGNMENT OF DRUG IDENTIFICATION NUMBERS FOR PRIVATE LABEL PRODUCTS".

Background:

The original policy entitled: "Assignment of Drug Identification Numbers for Private Label Products", has now been revised in response to comments from both our internal and external clients. The changes provide clarification and expanded guidance on when and how DINs are assigned for these type of products.

The present policy replaces the original policy dated January 1996 and is effective immediately.

Definitions:

1. FABRICATOR:
   
   For the purpose of this policy, a fabricator is a company that prepares and preserves a drug for the purpose of sale (referred to as "manufacturer" in the previous policy).
   
   
2. BRAND NAME:
   
   A brand name is defined as the name:
   1. that is assigned to a drug product by its fabricator;
   2. under which a drug product is sold or advertised; and,
   3. that is used to distinguish a drug product from other drug products.

It may or may not include the name of its fabricator, corporation, partnership or individual.

Assignment of DINs:

A DIN will be assigned according to the brand name identified by the applicant of the DIN. A product may be labelled for sale with the name or trademark of a distributor or retail outlet, in addition to the name of the fabricator.

DINs will be issued in the following manner:

SCENARIO A:

No identification of distributor or retail outlet provided on the label

A DIN will be issued for the brand name identified by the fabricator. For example, if the brand name is identified as "DRUG X", the DIN will be assigned to "DRUG X".

SCENARIO B:

Brand name includes name of distributor or retail outlet

If an applicant identifies the brand name of the product to include the name of the retail outlet or trademark, a DIN will be issued for that brand name. For example, if the brand name is identified as "FIRM 1 - DRUG Y", a DIN will be assigned to "FIRM 1 - DRUG Y".

Additional products labelled with other retail outlets or trademarks for
"DRUG Y" (e.g. "FIRM 2 - DRUG Y"), will require additional DINs. The applicant is required to apply for these additional DINs in separate DIN applications.

SCENARIO C:

Brand name does not include name of distributor or retail outlet, but distributor or retail outlet is identified on the product label.

If an applicant identifies the brand name "DRUG Z" of a product and does not include the name of a retail outlet or trademark, a DIN will be issued for that brand name "DRUG Z".

Products labelled with retail outlets or trademarks will not require additional DINs for "DRUG Z". It is the fabricator's responsibility to ensure that all drug products sold with the same brand name are identical except for the name of the retail outlet or trademark on the product label.

For example FIRM 2 fabricates DRUG Z that is labelled for sale as FIRM 1's DRUG Z and is also labelled for sale as FIRM 2's DRUG Z.

All aspects of DRUG Z remain the same, except for the identification of the retail outlet, FIRM 1 or FIRM 2 on the product labelling. The name of the fabricator FIRM 2 appears on both labels and the fabricator is the applicant of the DIN.

Procedures:

1. Fabricators are required to apply for DINs according to this policy. At the time of notification of sale, the fabricator is requested to submit final labels of all products, including those that will be identified with the same brand name.
   
   
2. If additional products with the same brand name are introduced to the market, the fabricator is requested to submit a letter informing the Therapeutic Products Programme of this and to include a copy of the new labelling material.