Summary - Guidance Document - Fees for the Right to Sell Drugs

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
    • 2.5.1 Eligibility for Fee Remission
    • 2.5.2 Documentation (Right to Sell Drugs Fee Remission Request and Attestation Form)
    • 2.5.3 Calculation of Fee with Remission
    • 2.5.4 Calculating and Requesting Remission of Fees Where Payment was Deferred

View complete guide

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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