On March 30, 2020, Health Canada published a Notice communicating that the use of the Regulatory Enrolment Process (REP) will be mandatory as of October 1, 2020, for 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. This process replaces the use of existing forms, such as the 3011 Drug Submission Application Form, and the Fee Form. It also allows for the submission of non-eCTD format submissions through the Common Electronic Submission Gateway (CESG).
In order to ensure that companies are able to submit their first transactions using REP as of Oct 1, 2020, we recommend that they start transitioning their products to the new process. This includes the following steps:
1) Get a CESG account, if a company does not already have one for their eCTD format dossiers. This process takes about 1 month.
2) For new companies, get a Company ID (or code) using the required REP template. This process takes about 1 week. For existing companies that do not know their Company IDs, this can be found at the top of the Annual Drug Notification Form.
3) For new dossiers, get a dossier ID. This process takes about 1 week. For existing companies that do not know their Dossier IDs, this can be found using the DSTS_IA.
Under REP, these 3 steps are required before a company can make a submission using REP. Since these 3 steps can take up to a month and a half for new companies, we recommend that they start ASAP. Also, product information is captured in its own template using REP, so transitioning your products’ information from the 3011 to that new template can take time for each product.”
Please note that REP Guidance document is available upon request via e-mail at hc.publications-publications.sc@canada.ca
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