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| 1. Name of User Fee | 2. Fee Type | 3. Fee-setting Authority | 4. Reason for Planned Introduction of or Amendment to Fee | 5. Effective Date of Planned Change | 6. Consultation and Review Process Planned |
|---|---|---|---|---|---|
| Authority to Sell Drugs Fees - AMENDED | Regulatory Service (R) | Financial Administration Act (FAA) | • Fees have not been revised since originally implemented in 1995-98,
while the cost of doing business and the number and scope of regulatory activities have increased • Current fees are not reflective of costs to deliver services within service standards • Auditor General recommended (2004 and 2006) costing be revised and funding be adequate • Part of efforts to establish a sustainable and sufficient funding platform to resource regulatory programs |
2011-12 | Having completed stakeholder consultations and two Independent Advisory Panels
(to address complaints under the User Fees Act), tabling of a User Fee Proposal for the Modernization of
Human Drug and Medical Device Fees is proposed for 2009-10, with publication of fee regulations in Canada Gazette
expected in 2010-11. Additional information on consultation activities is available on the HPFB Cost Recovery Initiative website: www.healthcanada.gc.ca/ hpfb_costrecovery |
| Certificates of Pharmaceutical Product Fees - AMENDED | Other Goods and Services (O) | Ministerial authority to enter into contract | |||
| Drug Establishment Licensing Fees - AMENDED | R | FAA | |||
| Drug Master File Fees - AMENDED | O | Ministerial authority to enter into contract | |||
| Drug Submission Evaluation Fees - AMENDED | R | FAA | |||
| Medical Device Licence Application Fees - AMENDED | R | FAA | |||
| Fees for Right to Sell a Licenced Medical Device - AMENDED | R | FAA | |||
| Medical Device Establishment Licensing Fees - AMENDED | R | FAA |