Notice: Confirmation of the Mandatory use of the Regulatory Enrolment Process (REP) as of October 1, 2020

Notice: Confirmation of the Mandatory use of the Regulatory Enrolment Process (REP) as of October 1, 2020 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. 2023-10-29 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetynoticemandatory useregulatory enrolment processREPcommon electronic submissions gatewayCESGpharmaceutical-and-biologic drugsradiopharmaceutical drugsdrugs for human-use Notice: Confirmation of the Mandatory use of the Regulatory Enrolment Process (REP) as of October 1, 2020HTML 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, 2020HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/processus-inscription-reglementaire/avis.html

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.

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