Notice: Guidance Document - Fees for the Right to Sell Drugs
March 14, 2017
Our file number: 17-103106-215
This guidance document has been updated, including its Document Change Log, to reflect the recent amendments to the Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs) (Regulations). The amendments mandate reporting of drug shortages and discontinuations by authorization holders to a third-party website for certain categories of drugs that have the potential, in a shortage or discontinuation situation, to adversely affect the health of Canadians.
The Guidance Document - Fees for the Right to Sell Drugs provides manufacturers and regulatory correspondents guidance on the step by step process for annual notification in accordance with section C.01.014.5 of the Food and Drug Regulations.
In addition, the document provides guidance on the right to sell fees that are payable by manufacturers at the time of annual notification. These fees are in accordance with Part 2, Division 4, Fees for Right to Sell Drugs contained in Fees in Respect of Drugs and Medical Devices Regulations.
For more information please contact:
Office of Submissions and Intellectual Property (OSIP)
Therapeutic Products Directorate
Finance Building, 1st Floor
Address Locator: 0201A1
Ottawa, Ontario K1A 0K9
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