Release of Draft Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINs)

Author: Karen Zhou

Health Canada recently released a draft guidance on regulatory requirements for Drug Identification Numbers (DINs). The intent of the document is to consolidate regulatory information regarding DINs which is currently spread out across several documents on Health Canada’s website. By combining regulatory requirements in one document and improving accessibility of information to the industry, Health Canada intends to demonstrate its commitment to transparency and openness.

The DIN is a unique identifier assigned to a drug and serves as a tool in the post-market activities of products on the market. A DIN is only assigned after an evaluation of the drug that it met the applicable requirements of the Food and Drug Act.

The following policies and guidance are consolidated in the proposed document:

·         Guidance Document: Cancellation of a Drug Identification Number (DIN) and Notification of Discontinuation of Sales

·         Issuance of Drug Identification Numbers for New Drugs

·         Notice: Instructions for filing Drug Notification Forms (DNF) and Supporting Documents Provided in Electronic Format

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

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

 A consultation period was held between January 25 and February 25, 2019.   

About the author:

Karen works in the medical device industry specializing in regulatory affairs and compliance. With experience in both the corporate sector and Canada's medtech startup scene, she understands the challenges facing medical device manufacturers of different scales, not the least of which are the regulatory concerns within startups among their many competing interests. She thoroughly enjoys contributing to CAPRA, and in her spare time, she enjoys taking classes to continue to expand her intellectual horizons, writing, and reading non-fiction. 

References

https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/drug-products/draft-guidance-regulatory-requirements-drug-identification-numbers.html