Guidance document : fees for the right to sell drugs.: H13-9/13-2019E-PDF
"Once a drug is authorized for sale in Canada, industry must pay an annual fee to retain the right to sell the drug in Canada. Health Canada has charged fees since 1995 in order to recover some of the associated costs with post-market regulatory activities such as assessing safety signals and trends and communicating about risks. This document provides guidance on how fees for the right to sell drugs will be administered in accordance with the Food and Drugs Act and as stipulated in the Fees in Respect of Drugs and Medical Devices Order and the Regulations Amending and Repealing Certain Regulations Made under the Financial Administration Act"--Introduction, page 6.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.866809&sl=0
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance document : fees for the right to sell drugs. |
| Variant title | Fees for the right to sell drugs |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Earlier edition | Guidance document |
| Format | Electronic |
| Electronic document | |
| Note(s) | Issued also in French under title: Ligne directrice : frais à payer pour le droit de vendre un médicament. "Pub.: 180725." Issued also in HTML format. |
| Publishing information | Ottawa, Ontario : Health Canada = Santé Canada, November 2019. ©2019 |
| Description | 1 online resource (11 pages) |
| ISBN | 9780660235646 |
| Catalogue number |
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| Subject terms | Drug approval -- Canada. Fees, Administrative -- Canada. |