Notice - Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs

Notice - Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs The draft guidance document clarifies the requirements for eligible drug submissions and applications under the administrative pathway. These submissions and applications do not contain scientific data, or require regulatory review. 2023-09-03 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetydraft guidance documentadministrative processingdrug submissions-and-applicationsdrug involving humandisinfectant drugseligible drug submissions-and-applicationsscientific dataregulatory review Notice - Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant DrugsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/drug-products/notice-draft-guidance-document-administrative-processing-drug-submissions-applications-human-disinfectant-drugs.html Notice - Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant DrugsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/participation-public-consultations/medicaments/avis-ebauche-ligne-directrice-traitement-administratif-demandes-drogues-usage-humain-produits-desinfectants.html

The draft guidance document clarifies the requirements for eligible drug submissions and applications under the administrative pathway. These submissions and applications do not contain scientific data, or require regulatory review.

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