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Guidance document : administrative processing of submissions and applications involving human or disinfectant drugs.H13-9/25-2020E-PDF

"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.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.890884&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleGuidance document : administrative processing of submissions and applications involving human or disinfectant drugs.
Publication typeMonograph
Language[English]
Other language editions[French]
Earlier editionGuidance document :
FormatDigital text
Electronic document
Note(s)
  • Cover title.
  • "Date posted: 2020/10/01."
  • "Pub.: 200167."
  • Issued also in HTML format.
  • Issued also in French under title: Traitement administratif des présentations et des demandes concernant les médicaments destinés aux humains ou les désinfectants.
  • Includes bibliographical references.
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, 2020.
  • ©2020
Description1 online resource (24 pages)
ISBN9780660358901
Catalogue number
  • H13-9/25-2020E-PDF
Subject terms
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