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Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada (GUI-0145).H139-30/2021E-PDF

"This guidance document sets out Health Canada’s interpretation of the requirements in sections C.01.014.8, C.10.004 and C.01.014.13 to C.01.014.14 of the FDR. These sections prohibit the holder of a DEL from distributing drugs intended for the Canadian market for consumption or use outside Canada unless the licensee has reasonable grounds to believe that doing so would not cause or worsen a drug shortage. The sections were implemented to safeguard the Canadian drug supply and help ensure that the people of Canada have continuous access to the drugs they need to maintain their health"--Purpose, page 5.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.921571&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleGuide to distributing drugs intended for the Canadian market for consumption or use outside Canada (GUI-0145).
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Guide sur la distribution des médicaments destinés au marché canadien pour consommation ou usage à l’extérieur du Canada (GUI-0145).
  • Includes bibliographical references (pages 13-14).
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, November 10, 2021.
  • ©2021
Description1 online resource (14 pages)
ISBN9780660406923
Catalogue number
  • H139-30/2021E-PDF
Departmental catalogue number210404
Subject terms
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