Description

By way of this update, Health Products and Food Branch (HPFB) is reminding sponsors that the mandatory date for use of the Regulatory Enrolment Process (REP) and the Common Electronic Submissions Gateway (CESG) is October 1, 2020 applicable to pharmaceutical, biologic and radiopharmaceutical drugs for human use as well as disinfectants, pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations.

Resources

Name	Format	Description	Link
Notice: Confirmation of the Mandatory use of the Regulatory Enrolment Process (REP) as of October 1, 2020	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process/notice.html
Notice: Confirmation of the Mandatory use of the Regulatory Enrolment Process (REP) as of October 1, 2020	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/processus-inscription-reglementaire/avis.html

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