Fees for human drugs

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Fees for regulatory activities related to human drugs (pharmaceutical and biological) are currently charged as per the Fees in Respect of Drugs and Medical Devices Regulations [2017-06-30]. As of April 1, 2020, fees for human drugs will be charged as per the Fees in Respect of Drugs and Medical Devices Order. Supporting guidance, forms and fee links are listed below.

Please visit How to Pay Fees for information regarding payment of invoices.

Human drug submission evaluation fees

Before a drug is authorized for sale in Canada, Health Canada reviews it to assess its safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, biologics, disinfectants and sanitizers with disinfectant claims.

For filling before April 1, 2020

For filling on or after April 1, 2020

Master file fees

A Master File is a reference that provides information about specific processes or components used in the manufacturing, processing, or packaging of a drug. The Master File is a useful vehicle for providing information to Health Canada, where the information provided is considered to be confidential business information and is not available to the manufacturer of the dosage form or to the sponsors of a drug submission, DIN (Drug Identification Number) application or clinical trial application (CTA). Health Canada must protect confidential business information in accordance with the Access to Information Act and the Food and Drugs Act.

For filing before April 1, 2020

For filing on or after April 1, 2020

Fees for examination of an application for an establishment licence

Health Canada has facility inspection programs in place to evaluate the compliance of establishments with regulatory requirements to engage in production, importation, testing and distribution of drugs.

Fees for the right to sell drugs

Health Canada monitors human drugs on the Canadian market through post-market surveillance and compliance and enforcement activities. Industry pays an annual fee for the right to sell human drugs and to maintain those drugs on the Canadian market. 

For filling before April 1, 2020

For filing on or after April 1, 2020

For all other human drug guidance documents and forms for submissions and applications, please visit:

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