Guidance document : administrative processing of submissions and applications involving human or disinfectant drugs.
Material type:
TextPublisher: Ottawa, ON : Health Canada = Santé Canada, 2020Copyright date: ©2020Description: 1 online resource (24 pages)Content type: - text
- computer
- online resource
- 9780660358901
- 0660358905
- 363.19 15
- cci1icc
Distributed by the Government of Canada Publishing and Depository Services Program (Weekly acquisitions list 2020-44).
Issued also in French under title: Ligne directrice : Traitement administratif des présentations et des demandes concernant les médicaments destinés aux humains ou les désinfectants.
"October 2020."
"Pub.: 200167."
Includes bibliographical references.
Unrestricted online access. Unrestricted online access. star CaOONL
Electronic monograph in PDF format.
"Pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations (hereafter the Regulations), no manufacturer shall sell a drug in Canada unless a Drug Identification Number (DIN) [C.01.014 (1)] or DIN and Notice of Compliance (NOC) [C.08.002 (1)] have been issued by Health Canada, which grants market authorization for that product. Manufacturers must notify Health Canada of information changes pertaining to the manufacturer and drug product as set out by paragraph C.01.014.4 (b) of the Regulations"--Introduction, page 7.
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