Fees for human drugs
On this page
- Human drug submission evaluation fees
- Master file fees
- Fees for examination of an application for an establishment licence
- Fees for the right to sell drugs
Fees for regulatory activities related to human drugs (pharmaceutical and biological) are 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.
- Guidance on evaluation fees for human drugs and disinfectants [2021-03-31]
- Human Drug (Pharmaceutical and Biological) Submission and Application Review Fees [2021-01-07]
- Guidance Document: Management of Drug Submissions and Applications [2019-11-08]
- Guidance Document: Management of Disinfectant Drugs Applications [2019-11-08]
- Drug Submission: Application Fee Form for Human and Disinfectant Drugs [2021-04-01]
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.
- Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements [2017-04-28]
- Drug Master File Applications Form [2013-12-09]
- Master Files (MF) Application Fee Form for Human Drugs [2021-04-01]
- Advance Payment Details for Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protection Applications [2020-03-23]
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.
- Drug Establishment Licensing Fees
- Guidance Document - Fees for the Review of Human and Veterinary Drug Establishment Licence Applications [2019-11-04]
- Guidance on Drug Establishment Licences (GUI-0002) [2020-04-01]
- Drug Establishment Licence Application Forms and Instructions (FRM-0033) [2020-04-01]
- Management of Applications and Performance for Drug Establishment Licences (GUI-0127) [2020-03-18]
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.
- Fees for the Right To Sell
- Guidance Document – Fees for the Right to Sell Drugs [2019-11-04]
- Information Sheet: Management of Drug Company Contact and Financial Account Information [2020-03-23]
For all other human drug guidance documents and forms for submissions and applications, please visit:
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