Notice - Revision of the Procedure on the issuance of Drug Identification Numbers (DINs) for Unit Dose Pre-filled Syringes

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June 10, 2010

Notice

Our file number: 10-112936-541

Revision of the Procedure on the issuance of Drug Identification Numbers (DINs) for Unit Dose Pre-filled Syringes

This Notice serves to inform all external stakeholders that Health Canada is modifying its current procedures on the issuance of one DIN for unit dose pre-filled syringes with the same concentration.

Pursuant to section C.01.014 (1), a DIN consisting of an eight (8) digit numerical code is assigned to each drug product marketed under the Food and Drugs Act and Regulations. A DIN identifies the following product characteristics: manufacturer, brand name, medicinal ingredient(s), and strength of medicinal ingredient, pharmaceutical form and route of administration. Where any of these product characteristics differ, a separate DIN submission is usually required.

To support Health Canada's ongoing effort to prevent potentially serious dosing errors, Health Canada has decided to issue separate DINs for the different package sizes of unit dose pre-filled syringes of the same strength.

Effective immediately, New Drug Submissions and DIN Applications involving unit dose pre-filled syringes of the same strength will result in the issuance of separate DINs for each package size. Please note that Health Canada will deal with already marketed products on a case-by-case basis.

Future refinements to this new procedure may be necessary as a result of experience gained during implementation.

Health Canada will evaluate the possibility of expanding the scope of this announcement to the issuance of separate DINs for all unit dose injectables for different package sizes; however, assessments of these types of products will be required before Health Canada can make a firm decision. If required, further communication on the expansion of the scope will be forthcoming.

Any questions or comments regarding this Notice should quote "Pre-filled syringes" in your subject line and should be directed to:

Submission and Information Policy Division
Therapeutic Products Directorate
Health Canada
101 Tunney's Pasture Driveway
1st Floor, Address Locator 0201A1
Ottawa, Ontario
K1A 0K9

E-mail: SIPDMAIL@hc-sc.gc.ca