Guidance Document: Master Files for Veterinary Products: Procedures and Administrative Requirements

Guidance Document: Master Files for Veterinary Products: Procedures and Administrative Requirements The objective of this guidance document is to outline the procedures that veterinary Master File (MF) holders must follow to file confidential business information (CBI) directly with Health Canada's Veterinary Drugs Directorate (VDD) that is cross-referenced in support of an Applicant's veterinary drug submission (including DIN (Drug Identification Number) applications.) 2021-07-08 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyGuidance documentveterinary master filesveterinary productsprocedures and administrative requirementsconfidential business informationan applicant's veterinary drug submission Guidance Document: Master Files for Veterinary Products: Procedures and Administrative RequirementsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/veterinary-drugs/legislation-guidelines/guidance-documents/master-files-veterinary-products-procedures-administrative-requirements.html#a-1 Guidance Document: Master Files for Veterinary Products: Procedures and Administrative RequirementsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments-veterinaires/legislation-lignes-directrices/lignes-directrices/fiches-maitresses-produits-veterinaires-procedures-exigences-administratives.html#a-1

The objective of this guidance document is to outline the procedures that veterinary Master File (MF) holders must follow to file confidential business information (CBI) directly with Health Canada's Veterinary Drugs Directorate (VDD) that is cross-referenced in support of an Applicant's veterinary drug submission (including DIN (Drug Identification Number) applications.)

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