Summary - Guidance Document - Fees for the Right to Sell Drugs
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Overview
This guidance document provides information on the regulatory requirements for the fees for the right to sell drugs. This includes:
- fee payment
- fee remission
- fee deferral
Who this guide is for
- manufacturers of drugs
In this guide
- 1 Introduction
- 1.1 Policy Objectives
- 1.2 Policy Statements
- 1.3 Scope and Application
- 1.4 Background
- 1.5 Definitions
- 1.6 Acronyms
- 2 Guidance for Implementation
- 2.1 General Contact Information
- 2.2 Regulatory Requirements Related to the Fees for the Right to Sell Drugs
- 2.2.1 Issuance of a Drug Identification Number (DIN)
- 2.2.2 Drug Notification Form (DNF)
- 2.2.3 Annual Notification
- 2.2.4 Dormant DIN
- 2.2.5 Discontinued Sale Notification
- 2.3 Fee Payment
- 2.3.1 Who is Responsible for Payment?
- 2.3.2 Where to Submit Payment of Invoice
- 2.3.3 Annual Fee
- 2.3.4 When to Pay Fees
- 2.4 Deferral of Fees and Timing of Deferred Payment
- 2.5 Fee Remission
Download PDF – (306 KB, 15 pages)
Details and history
Published: May, 1998
Updated: May 30, 2018
Part of topic: Guidance on legislation
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