00000nam 2200000zi 4500 9.866809 CaOODSP 20221107162138 m o d f cr cn||||||||| 190108e201911 onc o f000 0 eng d 9780660235646 CaOODSP eng rda CaOODSP n-cn--- H13-9/13-2019E-PDF Guidance document : fees for the right to sell drugs. Fees for the right to sell drugs Ottawa, Ontario : Health Canada = Santé Canada, November 2019. ©2019 1 online resource (11 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier 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. "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. Drug approval Canada. Fees, Administrative Canada. Canada. Health Canada, issuing body. Ligne directrice : (CaOODSP)9.866810 Guidance document (CaOODSP)9.856866 PDF 232 KB https://publications.gc.ca/collections/collection_2021/sc-hc/H13-9-13-2019-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees/right-to-sell-drugs-2019/document.html