Fees for Human Drugs
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] under the Financial Administration Act. Supporting guidance, forms and current fee links are listed below.
- How to Pay Fees [2016-08-02]
Human Drug Submission Evaluation Fees
Before a drug is authorized for sale in Canada, HC reviews it to assess its safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, biologics, disinfectants and sanitizers with disinfectant claims.
- Human Drug (Pharmaceutical and Biological) Submission and Application Review [2017-02-17]
- Guidance Document - Fees for the Review of Drug Submissions and Applications [2015-12-10]
- Drug Submission - Application Fee Form for Human and Disinfectant Drugs (PDF fillable/saveable - 500 KB) [2017-03-03]
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 that information is 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 law.
Master File fees were last updated May 1, 2017 as per the Notice of Intent published in Canada Gazette on April 22, 2017.
- Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements [2017-04-28]
- Updated Drug Master File Applications Form [2013-12-09]
- Master File (MF) Application Fee Form for Human Drugs (PDF fillable/saveable - 870 KB) [2017-05-01]
- (DOC Version - 67 KB) [2017-05-01]
Establishment Licence Fees
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 [2017-02-17]
- Drug Establishment Licence Application Forms and Instructions (FRM-0033) [2014-10-23]
- Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) [2011-04-01]
- Drug Establishment Licence Application:Forms and Instructions (FRM-0033) [2011-04-01]
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 maintain and sell human drugs in Canada.
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