Notice: Release of the Draft Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINs)

January 25, 2019

Our file number: 18-122097-698

The above referenced draft guidance was released by Health Canada for consultation and is being posted on the website for information and comment.

The draft guidance is intended to consolidate information on Drug Identification Numbers (DINs) and the related regulatory requirements. This draft guidance intends to provide assistance on the interpretation of the regulatory requirements associated with a DIN and to inform manufacturers on their obligation to accurately report notifications for a change of drug status to Health Canada.

The guidance document will be applicable to all drugs which have been issued a DIN pursuant to the Food and Drug Regulations.

The information provided in this guidance is currently available in different documents on the Government of Canada website. By consolidating this information into one document, Health Canada is demonstrating the Government of Canada's commitment to transparency and openness. By improving the accessibility of this information, it will assist the industry to understand and comply with current regulatory requirements.

In addition to this draft guidance document, modifications have been made to the Drug Notification Form to align with the required information as noted in this Guidance: changes to terminology (i.e. DIN holder), and removal of non-required information (i.e. schedule, pharmaceutical standard) as well as "New to the Canadian Market" and "Replacement of a previously notified product" statements. "Information on labels" has been updated to align with the mock-up requirements, as outlined in the Plain Language Labelling Regulations.

It is also important to note that amendments to draft documents may occur as a result of regulatory consultations and subsequent deliberations within Health Canada.

Comments provided to Health Canada should be submitted no later than February 8, 2019 in order to allow sufficient time for their assessment.

Comments should be directed to the Office of Submissions and Intellectual Property.