Guidance document: preparation of regulatory activities in non-eCTD format

Date adopted: 2023/06/09
Effective date: 2023/06/26
Revised date: 2023/06/09

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent, and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant programme area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy, or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable Guidance documents.

Document change log

Date Description

June 15, 2015

Notice: Health Canada's requirements for filing a regulatory activity in "non-eCTD electronic-only" format. (DIN)

September 25, 2015

Guidance Document: Preparation of Drug Regulatory Activities in "Non-eCTD Electronic-Only" Format. (DIN, MF)

February  29, 2016

Guidance Document: Preparation of Drug Regulatory Activities in "Non-eCTD Electronic-Only" Format. (Div.1, Div.5, Div.8, DSUR, Post-market Vigilance, Level III, DNF and MF)

October 31, 2016

Guidance Document: Preparation of Regulatory Activities in "Non-eCTD Electronic-Only" Format. (Medical Devices, and Veterinary Drugs)

February 28, 2022

Guidance Document: Preparation of Regulatory Activities in Non-eCTD Format (Medical Device information has been removed, information for regulatory activities that are mandatory in eCTD format has been removed, and updated information has been provided for revised processes and requirements)

October 1, 2022 Revisions required for mandatory use of Regulatory Enrolment Process (REP) for veterinary drugs, transmission and top level folder requirements for Developmental Safety Update Reports (DSUR), cover letter changes for Master files, directorate name change to Pharmaceutical Drugs Directorate (PDD), new Electronic Submission Gateway (ESG) Accounts Management Portal and minor revision to improve clarity throughout the document.
June 09, 2023 Revision required to update the Appendix G Electronic Submission Gateway, mandatory use of web-based Master File Application form and minor revision to improve clarity throughout the document.

Table of Contents

  1. 1. Introduction
    1. 1.1 Policy objectives
    2. 1.2 Policy statements
    3. 1.3 Glossary of terms
    4. 1.4 Background
    5. 1.5 Scope and application
  2. 2. Structure and content
    1. 2.1 Cover letter
    2. 2.2 Folder structure and file naming convention
      1. 2.2.1 Top level folder/dossier identifier
      2. 2.2.2 Common Technical Document (CTD) folder structure
      3. 2.2.3 Veterinary drugs folder structure
    3. 2.3 File naming convention
  3. 3. Technical requirements for regulatory activities
    1. 3.1 File format
    2. 3.2 Signatures
    3. 3.3 Validation of transaction
    4. 3.4 Transmission of electronic data
      1. 3.4.1 Sent via the CESG
      2. 3.4.2 Sent on media
      3. 3.4.3 Sent via email
    5. 3.5 Technical evaluation of a Regulatory Transaction
  4. 4. Important considerations
  5. 5. Appendices
    1. Appendix A: Other resources
    2. Appendix B: Contacts
    3. Appendix C: Master files (MF) sample folder structure(s)
    4. Appendix D: Distribution of master file information between the applicant and restricted parts
    5. Appendix E: UDRA table
    6. Appendix F: VDD folder structure
    7. Appendix G: Common Electronic Submission Gateway (CESG)

1. Introduction

This document defines the filing requirements and provides guidance on the structure, content and transmission of regulatory transactions filed in the non-eCTD format.

Health Canada has published requirements for the mandatory filing of specified regulatory activities in eCTD format. Refer to the Filing Submissions Electronically information page for more comprehensive requirements.

1.1 Policy objectives

The objective of this document is to provide operational direction and guidance to sponsors and Health Canada staff on the requirements for the preparation of:

  • Regulatory activities for Human drugs and disinfectants pursuant to Part C - Division 1 and Division 5 of the Food and Drug Regulations
  • Regulatory activities for Veterinary drugs pursuant to Part C - Division 1 and Division 8 of the Food and Drug Regulations
  • Human and Veterinary Master Files (MFs)

1.2 Policy statements

As part of ongoing efficiency measures and efforts to reduce regulatory burden on industry as well as to transition to an electronic environment, Health Canada has established the following options that are available immediately for filing regulatory activities in scope of this document and their related subsequent transactions:

Drugs and disinfectants for human use (Division 1)

  • Health Canada accepts regulatory activities for Division 1 human drugs in non-eCTD format. Regulatory activities for Division 1 human drugs can also be filed in eCTD format. Refer to the Filing Submissions Electronically information page for detailed information related to the eCTD format.
  • All regulatory transactions for human drugs, filed in either eCTD or non-eCTD format, pursuant to Part C, Division 1 of the Food and Drugs Regulationsmust also be filed using the Regulatory Enrolment Process (REP). Use of the REP enables transactions to be transmitted via the Common Electronic Submissions Gateway (CESG). Refer to the REP information page for detailed information.

Drugs for clinical trials involving human subjects (Division 5)

  • Health Canada accepts clinical trial regulatory activities filed in the non-eCTD format.
  • The eCTD format is recommended. Refer to the information available on the Filing Submissions Electronically information page for details.
  • Use of the REP is not available for clinical trial regulatory transactions.

Positron-emitting radiopharmaceuticals (PERs) used in basic clinical research studies (Division 3)

  • Health Canada accepts Basic Research Applications: Positron-emitting radiopharmaceuticals (BRAP) regulatory activities filed in the non-eCTD format.
  • Use of the REP is not available for BRAP regulatory transactions.

Veterinary drugs

  • Health Canada accepts veterinary drug regulatory activities filed in the non-eCTD format.
  • Use of the REP is mandatory as of October 1, 2022 to facilitate the transmission of transactions via the CESG. Refer to the REP information page for detailed information.

Medical devices

  • Health Canada accepts regulatory activities for medical devices in electronic only format; however, instructions are no longer provided in this guidance document. Refer to the page of Guidance Documents for Medical Devices for detailed information.

Master files

  • Use of the web-based Master File Application form is mandatory.
  • Health Canada accepts regulatory transactions for existing master files, where the master file number has already been assigned, in non-eCTD format.
  • All new master files must be filed in eCTD format.
  • All transactions for master files, regardless of their format, must be sent via the CESG.

1.3 Glossary of terms

Confidential Business Information: Information which provides a business advantage as a result of the fact that it is kept confidential. This is true whether the information is tangible or intangible. Confidential business information is broad enough to encompass trade-secrets.

Control number (Submission Number): A six (6) digit unique number assigned by Health Canada for each regulatory activity submitted by a stakeholder.

Dossier: A collection of all regulatory activities throughout the life cycle of a product or products (with the same medicinal ingredient(s)) for a stakeholder.

Note: For clinical trials, it is a collection of all regulatory activities throughout the life cycle of a single clinical trial protocol.

Dossier Identifier (ID): A code assigned by Health Canada to uniquely identify the dossier. The dossier ID is also referred to as the Top Level Folder Name. It consists of a lowercase letter followed by six (6) or seven (7) unique numbers depending on the regulatory activity type.

Drug Identification Number (DIN): An eight (8) digit numerical code assigned to each drug product in final dosage form approved under the Food and Drugs Act and its Regulations.

Drug Product (Dosage Forms): The finished product (e.g., tablets, capsules, injections, etc.).

Drug Substance (Drug Substances or Intermediates in the Production of Drug Substances): A pharmacologically active ingredient.

Leading Sheet: A document describing the information being provided (e.g. a document stating "this sub-folder contains the following documents…").

Master File (MF): Is a reference that provides information about specific processes or components used in the manufacturing, processing, and packaging of a drug.

Protocol Number: A protocol number is a variable length, alpha-numeric sequence used by stakeholders to assign a reference number to their protocol. The protocol number for clinical trials should remain the same for the duration of the trial. 

Regulatory Activity: A collection of all regulatory transactions throughout the process of a specific activity.

Regulatory Transaction: Any information package sent by the stakeholder as part of a regulatory activity such as initial data, unsolicited and solicited data (e.g. response to a clarification request, response to Notice of Non-Compliance (NON), Response to Notice of Deficiency (NOD) or Drug Notification Form (DNF).

Solicited and unsolicited information: Solicited information is considered any information that is requested by Health Canada during the processing, screening or review of a submission/application.

  • Solicited Information such as responses to Screening Deficiency Notice (SDN), NOD, NON or Response to a Clarification Request (e.g. response to telephone request, response to email request, response to screening Acceptance Letter, etc.).
  • Unsolicited information such as safety information, company name change during review or product name change during review.

Note: For more details about solicited and unsolicited information, see Section 12 "Solicited information during the Scientific Review" and Section 14 "Unsolicited information" in Health Canada's Guidance: Management of Drug Submissions and Application.

Stakeholder: Company, Sponsors/DIN owner/Manufacturer of pharmaceutical or biological drug for regulatory activities filed according to the Food and Drug Act and its Regulation, and Owner/Agent/Manufacturer for Master File.

Common Electronic Submission Gateway (CESG): CESG is an Agency-wide solution for providing electronic regulatory transactions. The CESG enables the secure submission of premarket and postmarket regulatory information for review. The CESG is the central transmission point for sending information electronically to the Health Canada. Within that context, the CESG is a conduit along which submissions travel to reach the proper Health Canada Directorate, Bureau or Office.

1.4 Background

The non-eCTD guidance document was initially published in 2015 and has been revised several times to reflect the onboarding of additional product lines to the non-eCTD format. This revision prescribes changes that have resulted since the previous version, stemming from various process implementations, such as the mandatory use of the eCTD format and the REP.

Consequently, the scope of non-eCTD format has decreased as mandatory eCTD format became more predominant. Furthermore, the REP was implemented for certain product lines to further align the intake process by facilitating the transmission of non-eCTD transactions via CESG, which would otherwise be sent on media.

1.5 Scope and application

The regulatory activities listed below and related regulatory transactions are eligible for filing in non-eCTD format.

Human drugs and disinfectants

Division 1

  • Application for Drug Identification Number (DINA)
  • Application for Drug Identification Number - Biologic (DIN-B)
  • Application for Drug Identification Number - Disinfectant (DIN-D)
  • Application for Drug Identification Number - Category IV Product (DIN-F)
  • Post-Authorization Division 1 Change (PDC)
  • Post-Authorization Division 1 Change - Biologic (PDC-B)
  • Post-DIN Notification (for DINA only)
  • Notices of Change: Level III (for DINB only)
  • Yearly Biologic Product Report (YBPR) – Biologic products
  • Pre-Submission Meeting Information (MPDIN)
  • Undefined Regulatory Activity (UDRA)Footnote i
  • Periodic Safety Update Report (PSUR-PV) or Periodic Benefit Risk Evaluation Report (PBRER-PV) when provided to the Marketed Health Products Directorate (MHPD)
  • Risk Management Plan (RMP-PV), when provided to MHPD
  • Other Post-market Vigilance data requested by MHPD
    • Post-Authorization commitments - Post market Vigilance (PA-PV)
    • Post-Authorization Act and Regulations - Post market Vigilance (REG-PV)
    • Issue Related Summary Report (IRSR-PV)
    • Risk Communication – Post market Vigilance (RC-PV)
    • Patient Safety/Advertising Ad-Hoc Post market requests (PSA-PV)

Division 5

  • Clinical Trial Application (CTA)
  • Clinical Trial Application - Amendment (CTA-A)
  • Clinical Trial Application - Notification (CTA-N)
  • Pre-Clinical Trial Application Consultation Meeting (Pre-CTA)

Division 3

  • Basic Research Applications: positron-emitting radiopharmaceuticals (BRAP)

Master files (existing master files only)Footnote ii

  • Type I Master Files - Drug Substance
  • Type II Master Files - Container Closure Systems and Components
  • Type III Master Files - Excipients
  • Type IV Master Files - Drug Product

Veterinary drugs

  • New Drug Submission (NDS)Footnote iii
  • New Drug Submission with Flexibilities for Designated COVID-19 drug (NDS CV)
  • Abbreviated New Drug Submission (ANDS) Footnote iv
  • Supplement to a New Drug Submission (SNDS)Footnote v
  • Supplement to an Abbreviated New Drug Submission (SANDS)Footnote vi
  • Notifiable Change (NC) Footnote vii
  • Periodic Safety Update Report Post-market Vigilance (PSUR-PV)
  • Application for Drug Identification Number Application - Veterinary (DINV)
  • Experimental Studies Certificate (ESC)
  • Experimental Studies Certificate (ESC) Amendments
  • Investigational New Drug (IND)
  • Investigational New Drug (IND) Amendments
  • Protocol Review
  • Post-Notice of Compliance Changes: Level III Form (for Veterinary drug dossiers only)
  • Veterinary Drugs Master Files (MF)
  • Submissions for international collaborative reviews, such as those under the Regulatory Cooperation Council (RCC)
  • Pre-Submission Meeting Information (e.g.: MPNDS, MPSNDS, MPDINV, MPSANDS, MPANDS, or MPESC)
  • Undefined Regulatory Activity (UDRA) Footnote viii

Other

  • Developmental Safety Update Report (DSUR)

Regulatory Transactions out of scope for non-eCTD format

The information currently not accepted in non-eCTD format includes:

  • Products regulated under the Natural Health Products Regulations
  • Site Master Files (submitted to Regulatory Operations and Enforcement Branch)
  • Site Reference File (SRF)
  • Medical Devices - Licence Application or Amendment (LAp or LAm)
  • Lot Release documentation (i.e. group 1a, 1b, 2, 3, 4 fax-backs)
  • Adverse Reaction Reports
  • A response to a request issued under the Access to Information Act (ATIA)
  • The Annual Drug Notification Form (ADNF) completed by the stakeholder
  • New Certificate of Supplementary Protection (CSP) Applications
  • CSP related Correspondence
  • Court documents (e.g. statements of claim, notices of application, notices of motion, etc.)
  • Pipeline meeting

2. Structure and content

All regulatory activities and subsequent regulatory transactions that are filed for review to Health Canada must be provided using the appropriate folder structure and document placement. Failure to file a transaction using the correct folder structure may result in the transaction not being accepted by Health Canada.

  • General requirements for folder structure are provided in this guidance document.
  • Zipped folder structures, for specific product lines, are available on the Filing Submissions Electronically information page. Stakeholders can use them to build a regulatory transaction for filing to Health Canada.
  • Details on the correct module 1 sub folders to place the documents in the regulatory transaction for human drugs and disinfectants, can be found on the Organization and Document Placement for Canadian Module 1 document available on the Filing Submissions Electronically information page.

2.1 Cover letter

The cover letter provides a brief description of what is in a regulatory transaction, which is used to support the processing of the transaction. Every regulatory transaction should be filed with an electronic cover letter, with the exception of transactions that contain only a Post NOC - Level III Changes Form. The information entered on the Regulatory Enrolment Process Regulatory Transaction template must align with the information on the cover letter. Delays will occur if conflicting information is provided, as Health Canada will need to confirm the intent to accurately process the transaction.

Below are some of the general requirements for cover letters:

  • Regulatory transactions that are sent on media should include a paper cover letter in addition to the electronic copy.
  • A cover letter must be less than four (<4) pages in length.
  • A cover letter does not require a signature.
  • A cover letter must only contain the required subset of information, as prescribed below; no supporting data should be included.

Health Canada requires the following content for all cover letters:

  • Clearly state what is being provided;
  • Reason for filing
  • Stakeholder Name and Role (e.g. Sponsor, Manufacturer, DIN Owner, or Agent)
  • Brand name
  • Dossier Identifier (ID) – if using REP and for all Master Files
  • Regulatory Activity type
  • Control number (if known)
  • Include reference to a correspondence and/or a request letter issued by Health Canada (including an Advisement Letter), if applicable
  • Clearly state any cross-referenced regulatory activity (include the date the regulatory activity was approved)
  • If applicable, include a list of eligible patent claims and a description of how such claims correspond to the regulatory activity in respect of which the patent list is filed, as well as page references to relevant portions of the drug submission should be included
  • Indicate the contact name and email address where the Validation Report (if required) should be sent
  • Responses to requests for clarification should clearly indicate the name of the requester

In addition to the above general requirements, the cover letters for the following transactions should include detailed information:

  • Other Sale Notifications:
    • UDRA: Notifications of interruption of sale should indicate the:
      • DIN(s) affected
      • Date the sale of the drug stopped (the cover letter should indicate that the product has not been sold for a period of 12 consecutive months)
    • UDRA: Notifications of discontinuation of sale (DIN cancellation) should indicate the:
      • DIN(s) to be cancelled
      • Discontinuation date
      • Expiry date of the last lot sold
      • Lot number of the last lot sold
  • PSUR or PBRER (when provided to MHPD) should also indicate which of the following applies:
    • Significant change in what is known about the risks and benefits of the health product
    • VOLUNTARY PSUR/PBRER - unsolicited information
    • REQUESTED PERIODIC PSUR/PBRER - requested by Health Canada (for example RMP follow-up or post-authorization commitment)
    • REQUESTED AD HOC PSUR/PBRER - provided as a one-time request made by either the pre-market review directorate reviewing the associated regulatory activity or by MHPD (the requester should be specified)
  • RMP (when provided to MHPD) should also indicate which of the following applies:
    • VOLUNTARY RMP - unsolicited information
    • REQUESTED AD HOC RMP - provided as a one-time request made by MHPD (the requester should be specified)
  • DSUR (when provided to PDD or BRDD) should also indicate which of the following applies:
    • REQUESTED - as per a request made by Health Canada
    • VOLUNTARY - important new safety information
  • Clinical Trial regulatory transactions should include the relevant protocol number
  • Master file conversions and reactivations must indicate if there is a new Letter of Access included, that has not been previously authorized
  • Withdrawal of Letters of Access, Agent withdrawal and Agent name change for Master Files should clearly indicate the name of the company and agent name
  • DINA regulatory activities should indicate if there is a labelling reference product

The cover letter must not contain the following:

  • Scientific information
  • Summary response in a Question and Answer format
  • Response to request for additional information
  • List of documents provided in the transaction

2.2 Folder structure and file naming convention

The content of the regulatory transaction filed for review must be organized in folders. Multiple documents must not be bundled into one file, but instead provided as separated documents. Each file/document must be placed in the required subfolders aligning with the appropriate structure. The complete folder structure for the following product lines is available as zipped file on the Filing Submissions Electronically information page. These zipped files can be downloaded and used to prepare a regulatory transaction for filing:

  • Division 1 human drugs and disinfectants
  • Division 5 human drugs
  • Master Files
  • Veterinary drugs

The following are common folders structure errors to avoid:

  • The top level folder must be the dossier ID for regulatory transactions using the REP; otherwise the transaction will fail validation.
  • The top level folder must not contain any files; it should only contain the required sub-folders.
  • Multiple documents provided, as a single PDF file is not acceptable.
  • Information provided in previous transactions must not be provided again, unless it is affected by a change (such as a MF update, MF letter of access, administrative change, and response to SDN).
  • Empty folders must not be included in the structure (i.e. If you are using the zipped folder structures, ensure that all subfolders that do not contain a file are deleted prior to sending the transaction to Health Canada).
  • Leading sheets at the beginning of sub-folders (indicating a folder is not applicable or describing the content) must not be provided.

Figure 1: Leading sheet

Figure 1: Leading sheet. Text description follows
Figure 1 Text Description

Figure 1 displays a sample folder structure requirement for a transaction. It shows that a folder name using a letter followed by a letter then 6 or 7 numbers should be used as the "Dossier Identifier".

  • Followed by, subfolder:
    • m1
  • Sub-subfolders:
    • 1.3 Product Information
    • 1.3.1 Product Monograph
  • Documents:
    • Product Monograph
    • Annotated Product Monograph
    • Annotated Product Monograph
    • Non-Annotated Product Monograph

Leading Sheets are an unacceptable way to introduce the documents provided in a section.

Note: * A letter followed by 6 or 7 digits depending on the regulatory activity type. 

For a detailed list of what files/documents to include in each folder, refer to the Organisation and Document Placement for Canadian Module 1 available on the Filing Submissions Electronically information page. For information on Modules 2-5 of the CTD structure, refer to the ICH M4: The Common Technical Document (CTD) developed by the International Council for Harmonisation (ICH).

For a detailed list of what files/documents to include in each folder for Veterinary Drugs transactions refer to Appendix V: Master Index of Guidance for Industry Preparation of Veterinary New Drug submissions and Appendix F of this document.

2.2.1 Top level folder/dossier identifier  

The top level folder is the main folder of a regulatory transaction that is filed to Health Canada and must be included with every transaction. All the subfolders and content files are located within the top level folder.

The top level folder must be the dossier identifier (dossier ID), unless specified below. The dossier ID is a lower case letter followed by six digits for pharmaceutical, biological, clinical trial, veterinary dossiers and seven digits for master file dossiers. All regulatory activities and associated transactions for a dossier must be filed under the same dossier ID. For product line specific details, see sections below and Table 1: Dossier information for summary.

Human drugs and disinfectants:

The transactions for human drugs and disinfectants must be sent via the CESG with REP. If the dossier ID is unknown, it must be requested using the appropriate dossier ID request form prior to filing.

For an existing dossier, we recommend that you first use the Drug Submission Tracking System – Industry Access (DSTS-IA) to look up the assigned dossier ID. This can be done by searching for a recent regulatory activity submitted to Health Canada that has the same medicinal ingredient(s) and brand name as the one you intend to file. If you do not have access to DSTS-IA, please contact the Office of Submission and Intellectual Property at client.information@hc-sc.gc.ca for information on creating a DSTS-IA account.

Note: For regulatory transactions being filed under the administrative pathway, a new dossier ID may be required. Please refer to the instructions on the "Help Text" section of the Dossier ID Request Form for details.

Veterinary drugs:

The transactions for veterinary drugs must be send via the CESG with REP. If the dossier ID is unknown, it must be requested using the appropriate dossier ID request form prior to filing.

For an existing dossier, we recommend that you first use the Drug Submission Tracking System – Industry Access (DSTS-IA) to look up the assigned dossier ID. This can be done by searching for a recent regulatory activity submitted to Health Canada that has the same medicinal ingredient(s) and/or brand name as the one you intend to file. If you do not have access to DSTS-IA, please contact the Office of Submission and Intellectual Property at client.information@hc-sc.gc.ca for information on creating a DSTS-IA account.

Note: For regulatory transactions being filed under the administrative pathway, a new dossier ID may be required. Please refer to the instructions on the "Help Text" section of the Dossier ID Request Form for details.

Clinical trials:

For the first transaction associated with a new protocol, the top level folder must be the product name or the protocol number. The dossier ID will be issued upon receipt of the pre-submission meeting or clinical trial application and must be used for all subsequent transactions associated with this protocol.

For the first transaction associated with a new DSUR, the top level folder must be the product name. The dossier ID will be issued upon receipt of the DSUR and must be used for all subsequent DSURs or DSUR related transactions.

Master files:

For existing master files, the top level folder and the dossier ID is a lower case 'f' followed by the 7 digit known master file number (e.g. f1234567). If you do not know your master file number, please contact the Master file unit at dmf.enquiries-fmm@hc-sc.gc.ca.

Reminder: All New master file must be sent in eCTD format and are outside the scope of this guidance document.

Table 1: Dossier information
Dossier type Dossier ID format Dossier ID request

Pharmaceutical

dXXXXXX

Dossier ID request form

Biological

dXXXXXX

Dossier ID request form

Veterinary

vXXXXXX

Dossier ID request form

Clinical trial

cXXXXXX

Dossier ID request does not apply

Master file

fXXXXXXX

Dossier ID request does not apply

Dossier IDs that have not been used within 18 months of their issuance are automatically deleted from Health Canada's tracking system, without any notification to the sponsor. If a sponsor intends to use a dossier ID that has been deleted a new dossier ID request form will be required; however, the request should indicate the previously issued dossier ID.

2.2.2 Common Technical Document (CTD) folder structure

The ICH CTD structure must be used to organize the documents provided for human drug and disinfectant regulatory transactions, pursuant to division 1, division 5 or master files. This structure consists of five (5) modules, each containing multiple subfolders to be used for specific documents.

2.2.2.1 Module 1 folders

The requirements for module 1 of the CTD structure is regional and therefore defined by Health Canada. Refer to the Organisation and Document Placement for Canadian Module I, available on the Filing Submissions Electronically page for a detailed list of the documents required in each subfolder in this module.

Specific content requirements by product line:

Clinical trials

  • When filing clinical trial applications, stakeholders may also refer to "Table 1: Contents of Submission Package in accordance with CTD Format" of the Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications for further clarity.

Master files

  • When providing MF Types I, II, III & IV, the folders in module 1 will be considered as the Restricted Part (RP). See Appendix D of this document for illustrations.
  • Refer to the Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements as well as the folder structures provided in the Appendix C of this document for more information on the structure of module 1 for each MF transaction type.

Veterinary drugs

  • Refer to section 2.2.3 of this guidance document for veterinary drug folder structure.
  • For the folder structure when providing a master file for a veterinary drug, refer to Appendix C of this document.

2.2.2.2 Modules 2 to 5 folders

The structure and names of the modules 2 to 5 folders are defined in the M4: Common Technical Document found on the International Council for Harmonisation (ICH) website.

When providing information in the module 3: Regional Information section, the following subfolders should be created for specific documents:

  • 3.2.R.1 Production Documentation
  • 3.2.R.2 Medical Devices
  • 3.2.R.3 Lot Release Documentation
  • 3.2.R.4 Yearly Biologic Product Report
  • 3.2.R.5 Assessment of Similarity
  • 3.2.R.6 On Site Evaluation
  • 3.2.R.7 Other Regional Information
  • 3.2.R.8 Product Lifecycle Management Information

Specific content for specific folders:

Clinical trials

  • When filing clinical trial applications, stakeholders may also refer to "Table 1: Contents of Submission Package in accordance with CTD Format" of the Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications for further clarity.
  • When providing literature references related to non-clinical or clinical studies, they should be placed in module 4 (section 4.3 Literature References, non-clinical related) or module 5 (section 5.4 Literature References, clinical related). If providing study related information, such as study synopses, study summary, they should also be placed in appropriate sections and subsections of module 4 and module 5 respectively.

Master files

  • When providing MF Types I & IV, two separate documents should be included in the folder "2.3 Quality Overall Summary," a "QOS (RP)" and a "QOS (AP)" files.
  • When providing an MF:

Type I – Drug Substance (see figure C-1 in Appendix C of this document for an illustration):

  • The folder "3.2.S Drug Substance" should be duplicated and each clearly identified as either the Applicant's Part or the Restricted Part using the abbreviations "AP" or "RP" respectively.
  • The folder "3.2.A Appendices" will be considered as the Restricted Part (RP).

Type II – Container Closure Systems, there are two possible options for structuring the folders in Module 3.  (See figure C-2 in Appendix C of this document for an illustration).

  • A separate subfolder under "3.2.P.7 Container Closer System" can be used for each component provided, or
  • The folder "3.2.P Drug Products" (with all its subfolders) can be used for information that is common to all components and separate subfolders under "3.2.P.7 Container Closer System" can be used for information specific to each component.

Type III – Excipients (See figure C-3 in Appendix C of this document for an illustration):

  • The folder "3.2.P.4 Control of Excipients" in module 3 should be duplicated for each excipient provided.

Type IV – Drug Products (see figure C-4 in Appendix C of this document for an illustration):

  • The folder "3.2.P Drug Products" should be duplicated and each clearly identified as either the Applicant's Part or the Restricted Part using the abbreviations "AP" or "RP" respectively.
  • The folders "3.2.A Appendices" and "3.2.R Regional Information" will be considered as the Restricted Part (RP).

2.2.3 Veterinary drugs folder structure

The structure and name of the folders for veterinary drug regulatory activities are defined in Appendix V: "Master Index" of Health Canada's Guidance for Industry: Preparation of Veterinary New Drug Submissions and the Appendix F of this document.

A zipped folder structure is also available on the Filing Submissions Electronically page to assist stakeholders in preparing their regulatory activities.

Post – NOC Level III changes forms should be structured as outlined in Appendix F – Figures F-4 of this document.

2.3 File naming convention

With the exception of the file extension, the file naming convention within each folder is left to the stakeholder preparing the regulatory transaction. However, Health Canada suggests that the file names be kept as brief and meaningful as possible, while adhering to the following:

  • File names should describe the content in a meaningful way and must be limited to a maximum of 50 characters, including the file extension.
  • Commonly used and meaningful abbreviations, such as QOS for Quality Overall Summary, may be used to shorten file names.
  • Files provided electronically must not be password protected.
  • REP file names are system generated and should not be modified.

3. Technical requirements for regulatory activities

3.1 File format

Portable Document Format (PDF) (versions 1.7, PDF/A-1 and PDF/A-2)Footnote ix is the recommended format for electronic documents, although other formats such as Microsoft® Office 2016 (.docx, .xlsx) may also be accepted.

PDF versions of documents should be generated from electronic source documents and not from scanned materials, except where access to an electronic source document is unavailable or where a signature is required.

It is important that PDF files be properly bookmarked. Rule of thumb for good bookmarking include:

  • Documents that are ten pages or more should be bookmarked.
  • Bookmarks are used by Health Canada as a document Table of Contents and should not include the regulatory activity level.
  • Sections, subsections, tables, figures, and appendices should all be bookmarked.
  • Having too many levels of bookmarks is inefficient; in most instances, four levels of bookmarks should be sufficient:
    • 1 Heading
      • 1.1 Subheading
        • 1.1.1 Sub-subheading
          • 1.1.1.1 Sub-Sub-Subheading

Health Canada recognizes that bookmarks are generated automatically from document headings, but nevertheless recommends they be kept concise.

It is important that PDF files be properly hyperlinked:

  • Hyperlinks within the same PDF document are acceptable, but hyperlinks between different documents are not to be used.
  • It is the responsibility of the stakeholder preparing the regulatory transaction to ensure that hyperlinks are functioning.
  • Links must also include references to the specific section or page in the event the link is broken.
  • The required hyperlinks to related information should be included only in the PDF version of files.

Specific format requirements:

The documents in the Table 2 must be provided in PDF and/or Microsoft® Word 2016 format(s) as specified.

Table 2: Specific file format requirements for drugs
List of Documents provided with Human Drugs File Format*
PDF Word

Certified Product Information Document (CPID)

Annotated

-

Non-annotated

-

Comprehensive Summary: Bioequivalence

HC-SC3011 Form (if not using REP)

 

Label Safety Assessment Update - Sponsor Attestation

Product Monograph (PM)/Prescribing Information

Annotated

Non-annotated

-

Second language

-

Protocol Safety and Efficacy Assessment Template (PSEAT) - CTA

-

Quality Overall Summary (QOS)

Clinical Trial Applications

-

All other regulatory activities in scope of non-eCTD format

Response document for responses to clarification requests, SDN, NON, NOD

('' = Required  /  '-' = Not Applicable)

* When PDF and Word are selected, the document should be provided in both formats

* HC-SC3011 can be provided in PDF or Word format. Both formats are not required.

  • Presentations for meetings with Health Canada (e.g., pre-submission meetings), can be provided in Microsoft® PowerPoint 2016 (.pptx) format.
  • Division 1 – The "BE data sets" must be provided in ASCII format. For more information, see Health Canada's Guidance for Industry: Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format, Appendix B: "Computer Format for the Submission of Data for Comparative Bioavailability Studies".
  • Regulatory Enrolment Process (REP) files must be provided in XML format. For more information, refer to the REP information page.

To obtain a complete list of acceptable file formats, size of files, etc. refer to the non-eCTD validation rules available on the Filing Submissions Electronically information page.

Contact OSIP for other file formats that may be acceptable at the time of filing. See Appendix B of this document for full contact information.

3.2 Signatures

Documents that legally require signatures may be signed with an electronic signature (e.g. an image of the official's wet ink signature, digital signature), or the signature page can be printed, signed, scanned and saved as a pdf file.

If only one page of a multi-page PDF document contains a signature, the stakeholder should scan that page and then include the scanned page at the same location in the PDF file of the document. Each document should have only one PDF file.

Certain Health Canada documents may have alternate instructions for signatures such as the electronic
PDF fillable forms available on the Health Canada website, e.g. Certificate of Suitability (CEP), CEP
attestation, or a letter of access (LOA).

The cover letter does not require a signature. However, contact information, including printed name, phone number, and email address, should be provided.

3.3 Validation of transaction

All regulatory transactions should be validated prior to transmitting to Health Canada. For validation criteria refer to the posted validation rules on Health Canada's website.

3.4 Transmission of electronic data

The acceptable method of transmissions are CESG, media and email. All other methods of transmission, such as Dropbox and secure FTP sites, are not acceptable.

3.4.1 Sent via the CESG

The use of the CESG is mandatory to the following regulatory transactions:

  • Transactions within scope of REP
  • Transactions for master files

Prior to using the CESG for sending transactions, stakeholders must register as a trading partner. For detailed information on how to become a trading partner, refer to the CESG information page, and Appendix G of this Guidance document.

Health Canada requires that regulatory transactions over 5GB in size be sent after 4:30 PM EST.

3.4.2 Sent on media

Regulatory transactions not accepted via CESG, should be provided on media. A paper copy of the cover letter and media should be mailed to the appropriate address as indicated in Appendix B of this document.

The accepted media formats for providing electronic regulatory transactions are:

  • Compact Disc-Recordable (CD-R) conforming to the Joliet specification
  • Universal Serial Bus (USB) 2.0 or 3.0 drive
  • Digital Versatile Disc (DVD-RAM and DVD+R/-R) in Universal Disk Format (UDF) standard

All media should be labelled. The label on the disc/drive should contain the following information:

  • Stakeholder Name
  • Brand Name
  • Dossier ID (if known)

Subsequent to burning the CD/DVD or transferring data to a drive, stakeholders should ensure that all files can be opened, files are not corrupted, and that "Thumb.db" files are removed.

Clinical trial and DSUR

  • Clinical Trial regulatory transactions and DSURs must be sent directly to the appropriate Directorate (Office of Clinical Trials at PDD for Pharmaceuticals or Office of Regulatory Affairs at BRDD for Biologics and radiopharmaceuticals) to the address outlined in Appendix B of this document.

3.4.3 Sent via email

The below specified regulatory transactions may/should be provided to Health Canada via email. However, the stakeholder assumes the risk of transmitting "Protected B" information through email.

Regulatory transactions provided by email should meet the following requirements:

  • The maximum email size accepted by the corporate mail server is 20 megabytes, anything larger should be sent on media.
  • If the regulatory transaction is provided via email, a duplicate copy must not be provided by mail.
  • The regulatory transaction should be organized in folders (see section 2.2 of this guidance document) and provided as a zipped file.
  • The body of the email should only contain the zipped regulatory transaction; no other documents or related information should be included.
  • Zipped files and documents contained in the email should not be password protected.

DIN cancellation and Notification of Interruption of sale

For information on how to send Notification of Discontinuation of Sale (DIN cancellation) and Notification of Interruption of Sale refer to the Guidance document: Regulatory requirements for Drug Identification Numbers (DINs).

Clinical trials

If the clinical trial related transaction is larger than 20 megabytes, the transaction may be split and sent as separate emails (e.g. one email for Module 1, and one email for Module 2/3). The subject line of the emails should clearly link to one another (e.g. "Email 1 of 2" and relevant subject line).

  • Responses to a Clarification Request (IR) for Clinical Trials should be sent via email:
    • Email should be addressed to the requestor(s) identified in the clarification request.
    • The subject line of the email should include the statement:
      • "Division 5 - IR (< Protocol Number(s)>, <Control Number(s)>)"
    • The zipped file should be named:
      • "IR (<Protocol Number(s)>, <Control Number(s)>)".
  • Responses to a No Objection Letter (NOL) for Clinical Trials can be sent via email to:
    • brdd.cta-dec.dmbr@hc-sc.gc.ca for biologic and radiopharmaceutical drugs.
    • The subject line of the email should include the statement:
      • "Division 5 – Response to CTA/CTA-A NOL (<Protocol Number(s)>, <Control Number(s)>)"
    • The zipped file should be named:
      • "Response to CTA/CTA-A NOL (<Protocol Number(s)>, <Control Number(s)>)"
  • Clinical Trial Application Notifications (CTA-N) should be sent via email to:
    • brdd.ctan-ndec.dmbr@hc-sc.gc.ca for biologic and radiopharmaceutical drugs
    • oct.ctan-ndec.bec@hc-sc.gc.ca for pharmaceutical drugs
    • The subject line of the email should include the statement:
      • "Division 5 – CTA-N (, <Protocol Number(s)>, <Parent CTA Control Number(s)>)".
    • The zipped file should be named:
      • "CTA-N (<Protocol Number(s)>, <Parent CTA Control Number(s)>)".
  • DSURs should be sent via email to:
  • Basic Research Application: PERS (BRAP) regulatory transaction should be sent via email to brdd.bra-daerf.dmbr@hc-sc.gc.ca.

3.5 Technical evaluation of a regulatory transaction

Upon receipt of a regulatory transaction, Health Canada performs a technical evaluation to ensure that it conforms to the requirements outlined in this and other relevant documents available on the Filing Submissions Electronically information page.

At each technical evaluation stage, a written correspondence from Health Canada will be issued via email if there are errors or deficiencies identified with the transaction. Stakeholders may reply to the email if they wish to further discuss the errors and/or deficiencies.

Reminder: Ensure to indicate a valid email address on the cover letter where any correspondence regarding your transaction must be sent.

When required, the stakeholder must correct the previously submitted regulatory transaction and re-file it to Health Canada in a timely manner. Upon receipt by Health Canada, the re-filed transaction undergoes technical evaluation again. This process is iterative.

During the technical evaluation process, the document content of the regulatory transaction is not reviewed. When the technical evaluation of the regulatory transaction has been completed, the administrative, screening, and/or evaluation process is initiated.

The technical evaluation process has three stages:

CESG compliance

For transactions received via the CESG, the first stage of the technical evaluation consists of verifying the folder structure (use of top level folder) and technical aspects of the transaction as per the CESG requirements. Refer to Appendix G of this Guidance document.

Written communication (in some cases with attached Validation Report) will be sent to the stakeholder if there are issues encountered at this stage; such as missing top level folder, file path is too long, or if Health Canada is not able to extract the content of the transaction.

Technical validation

The technical validation is conducted by a validation software using the latest published validation rules for the non-eCTD format.

If technical validation fails, a Validation Report describing the errors will be emailed, as a PDF attachment, to the stakeholder.

Manual verification

The third stage is a manual verification of the particular regulatory transaction type as per the submission/application processing section and associated timelines as outlined in the Guidance Document: The Management of Drug Submissions and Applications, or the Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements. In addition, verification of the placement of documents, particularly in Module 1 is conducted.

4. Important considerations

  1. For transactions sent incorrectly via the CESG, the stakeholder must notify Health Canada via email prior to modifying and/or resending the transaction via CESG. Health Canada will provide instructions on how to proceed. Do not resend without prior consultation and confirmation.
  2. Issues found during the technical evaluation such as CESG compliance issues, technical validation errors, or manual processing issues (e.g. incorrect structure) will result in Health Canada sending a validation report and/or processing hold email. To resolve such errors and issues, stakeholders are required to correct the failed transaction and re-file the whole transaction.
    However, if Health Canada is requesting missing documents, new documents, or corrections to the documents (identified during processing, screening or review), then responses to any Health Canada issued correspondence (e.g. clarification request, SDN, or on process hold) require a subsequent transaction with the requested documents only. In these cases, do not re-submit the entire original submission in your subsequent transaction, addressing the deficiency is sufficient. Include a new cover letter in module 1.0.1 explaining the reason for filing. In addition include a copy of the issued correspondence in module 1.0.3 – Health Canada issued correspondence, REP regulatory transaction xml file (when sending via the CESG) and new or revised requested documents. The information on how to refile a transaction which failed validation or has missing or incorrect documents are always outlined in the Health Canada issued correspondence.
  3. The content of the regulatory activity in non-eCTD format is the legal document; therefore, convenience copies provided directly to reviewers via email (with the exception of those indicated in section 3.4.3 of this document) have no legal value and will not be uploaded on the Health Canada internal systems.
  4. When providing MF Types I, II, III & IV, the folders in Module 1 will be considered as the Restricted Part (RP). See Appendix D of this document for illustrations.
  5. Stakeholders should contact the applicable review bureau to confirm prior to filing if they are unsure of which regulatory activity type to file.
  6. Regulatory transactions using REP:
    • A dossier ID is required prior to filing a regulatory transaction using the REP. Use the appropriate dossier ID request form from the REP information page to obtain a dossier ID.
    • Once a stakeholder files a regulatory activity using the REP, all additional information and subsequent regulatory activities/transactions for the same dossier must also be filed using the REP.
    • If a stakeholder is filing transactions using the REP, requirements for documents (e.g. HC-SC3011 form, fee form, cover letter) may differ from that which is prescribed in this document. For such cases, instructions in the REP guidance document will supersede this document. Refer to the REP information page for more details.
  7. Switching from non-eCTD to eCTD format:
    For human drugs and disinfectants, switching from non-eCTD to eCTD format is permitted with a new regulatory activity (i.e. sequence 0000 should be the first transaction for a new regulatory activity) or once a regulatory activity has been cleared (i.e. sequence 0000 can be post-clearance data). However, switching format in the middle of screening/review is not permitted (i.e. sequence 0000 cannot be a response to clarification request transaction).

    For information regarding conversion of Master files from non-eCTD to eCTD format, refer to the Master File Guidance Document.

Appendices

Appendix A: Other resources

This resource should be read in conjunction with the following resources however not limited to:

  • Documents available on the Filing Submissions Electronically page
  • Documents available on the REP information page.
  • Guideline on Preparation of Drug Identification Number Submissions
  • Guidance Document on Post-Drug Identification Number (DIN) Changes
  • Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications
  • Guidance Document: The Management of Drug Submissions and Applications
  • Guidance Document: Post-Notice of Compliance (NOC) Changes: Quality Document
  • Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document
  • Guidance Document: Post-Notice of Compliance (NOC) Changes: Framework Document
  • Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs
  • Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements
  • Guidance Document: Master File for Veterinary Products: Procedures and Administrative Requirements
  • Guidance for Industry Preparation of Veterinary New Drug Submissions
  • Guidance for Industry - Management of Regulatory Submissions (for Veterinary Drugs)
  • Guidance for Industry - Preparation of Veterinary Abbreviated New Drug Submissions - Generic Drugs
  • Draft Guidance for Industry: Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format

Appendix B: Contacts

Office of Submissions and Intellectual Property (OSIP)

General enquiries email: ereview@hc-sc.gc.ca

Master file enquires:

Master file enquiries email: dmf.enquiries-fmm@hc-sc.gc.ca

Clinical trial applications – Pharmaceuticals

Office of Clinical Trials
Pharmaceutical Drugs Directorate
Health Canada
5th Floor, Holland Cross, Tower B
1600 Scott Street, Address Locator 3105A
Ottawa, ON, Canada
K1A 0K9

General enquiries email: oct.enquiries-requetes.bec@hc-sc.gc.ca
CTA-N email: oct.ctan-ndec.bec@hc-sc.gc.ca
DSUR email: pdd-pv-dmp@hc-sc.gc.ca

Clinical trial applications - Biologics and radiopharmaceuticals

Office of Regulatory Affairs
Biologics and Radiopharmaceutical Drugs Directorate
Ground Floor, Health Canada Building #6
100 Eglantine Driveway
Address Locator 0601C
Ottawa, ON, Canada
K1A 0K9 

General Enquiries email: brdd.ora@hc-sc.gc.ca
CTA-N email: brdd.ctan-ndec.dmbr@hc-sc.gc.ca

Veterinary Drugs Directorate (VDD)

General enquiries email: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca

Other

Contact information for specific review center/bureau/office responsibilities can be found in the Guidance Document: Management of Drug Submissions and Applications

Appendix C: Master files (MF) sample folder structure(s)

Figure C-1: MF Type I - Drug Substance

Figure C-1: MF Type I - Drug Substance. Text description follows
Figure C-1 Text Description

Figure C-1 displays the sample module 1 to 3 folder structure requirements for a Master File Type I regulatory activity. 

The Dossier Identifier should be "f" followed by seven numbers (MF number).

  • Followed by, subfolder:
    • m11
  • Sub-subfolders:
    • 1.0 Correspondence
    • 1.0.1 Cover Letter
    • 1.0.3 Copy of Health Canada Issued Correspondence
    • 1.0.4 Health Canada Solicited Information
    • 1.0.7 General Note to Reviewer
    • 1.1 Table of Contents
    • 1.2 Administrative Information
    • 1.2.1 Application Form
    • 1.2.2 Fee Forms
    • 1.2.3 Certification and Attestation Forms          
    • 1.2.5 Compliance and Site Information
    • 1.2.6 Authorization for Sharing Information
    • 1.2.7 International Information            
  • Subfolder:
    • m2
  • Sub-subfolder:
    • 3 Quality Overall Summary2
  • Subfolder:
    • m3
  • Sub-subfolders:
    • 1 Table of Contents of Module 3
    • 2 Body of Data
    • 2.S Drug Substance (AP)3
    • 2.S.1 General Information
    • 2.S.2 Manufacture
    • 2.S.3 Characterisation
    • 2.S.4 Control of Drug Substance
    • 2.S.5 Reference Standards or Materials
    • 2.S.6 Container Closure System
    • 2.S.7 Stability
    • 2.S Drug Substance (RP)3
    • 2.S.2 Manufacture
    • 2.S.3 Characterisation
    • 2.S.4 Control of Drug Substance
    • 2.A Appendices1
    • 2.A.1 Facilities and Equipment
    • 2.A.2 Adventitious Agents Safety Evaluation

1 All documents in this folder will be considered as Restricted Part (RP) of the MF.

2 Two separate documents should be included in the folder "2.3 Quality Overall Summary", a "QOS (RP)" and a "QOS (AP)" files.

3 (AP) or (RP) should be used in the subfolder names to identify if the folder is Applications Part or Restricted Part.

  1. All documents in this folder will be considered as Restricted Part (RP) of the MF.
  2. Two separate documents should be included in the folder "2.3 Quality Overall Summary," a "QOS (RP)" and a "QOS (AP)" files.
  3. (AP) or (RP) should be used in the subfolder names to identify if the folder is Applicants Part or Restricted Part.

Figure C-2: MF Type II – Container Closure Systems and Components 

Figure C-2: MF Type II – Container Closure Systems and Components. Text description follows
Figure C-2 Text Description

Figure C-2 displays the sample module 1 to 3 folder structure requirements for a Master File Type II regulatory activity. 

The Dossier Identifier should be "f" followed by seven numbers (MF number).

  • Followed by, subfolder:
    • m1
  • Sub-subfolders:
    • 1.0 Correspondence
    • 1.0.1 Cover Letter
    • 1.0.3 Copy of Health Canada Issued Correspondence
    • 1.0.4 Health Canada Solicited Information
    • 1.0.7 General Note to Reviewer
    • 1.1 Table of Contents
    • 1.2 Administrative Information
    • 1.2.1 Application Form
    • 1.2.2 Fee Forms
    • 1.2.3 Certification and Attestation Forms
    • 1.2.5 Compliance and Site Information
    • 1.2.6 Authorization for Sharing Information
    • 1.2.7 International Information                                    
    • 1.3 Product Information
    • 1.3.6 Certified Product Information Document

Option#1 for module 3: recommends a separate subfolder for each component in folder "3.2.P.7 Container Closure System".

  • Subfolder for option#1:
    • m3
  • Sub-subfolders for option#1:
    • 3.1 Table of Contents of Module 3
    • 3.2 Body of Data
    • 3.2.P Drug Product
    • 3.2.P.7 Container Closure System
  • Sub-sub-subfolders for option#1:
    • Component X
    • Component Y
    • Component Z

Option #2 for module 3: recommends three separate folders "3.2.P.7 Container Closer System" subfolders should be added as required and common information in other folders.

  • Subfolder for option#2:
    • m3
  • Sub-subfolders for option#2:
    • 3.1 Table of Contents of Module 3
    • 3.2 Body of Data
    • 3.2.P Drug Product
    • 3.2.P.1 Description and Composition of the Drug Product
    • 3.2.P.3 Manufacture
    • 3.2.P.3.1 Manufacturer(s)
    • 3.2.P.3.3 Description of Manufacturing Process and Process Controls
    • 3.2.P.3.5 Process Validation and/or Evaluation
    • 3.2.P.5 Control of Drug Product
    • 3.2.P.5.1 Specification(s)
    • 3.2.P.5.2 Analytical Procedures
    • 3.2.P.7 Container Closure System
  • Sub-sub-subfolders for option#2:
    • Component X
    • Component Y
    • Component Z

Two options are recommended for providing multiple components in the M3 folder.

Figure C-3: MF Type III – Excipients

Figure C-3: MF Type III – Excipients. Text description follows
Figure C-3 Text Description

Figure C-3 displays an example module 1 to 3 folder structure for a Master File Type III regulatory activity. 

The Dossier Identifier should be "f" followed by seven numbers (MF number). 

  • Followed by, subfolder:
    • m1
  • Sub-subfolders:
    • 1.0 Correspondence
    • 1.0.1 Cover Letter
    • 1.0.3 Copy of Health Canada Issued Correspondence
    • 1.0.4 Health Canada Solicited Information
    • 1.0.7 General Note to Reviewer
    • 1.1 Table of Contents
    • 1.2 Administrative Information
    • 1.2.1 Application Form
    • 1.2.2 Fee Forms
    • 1.2.3 Certification and Attestation Forms
    • 1.2.5 Compliance and Site Information
    • 1.2.6 Authorization for Sharing Information
    • 1.2.7 International Information                        
    • 1.3 Product Information
    • 1.3.6 Certified Product Information Document
  • Subfolder:
    • m3
  • Sub-subfolders:
    • 3.1 Table of Contents of Module 3
    • 3.2 Body of Data
    • 3.2.P Drug Product
    • 3.2.P.4 Control of Excipients [Excipient X]1
    • 3.2.P.4 Control of Excipients [Excipient Y]1
    • 3.2.P.4 Control of Excipients [Excipient Z]1
    • 3.2.P.4.1 Specifications
    • 3.2.P.4.2 Analytical Procedures
    • 3.2.P.4.3 Validation of Analytical Procedures
    • 3.2.P.4.4 Justification of Specifications
    • 3.2.P.4.5 Excipients of Human or Animal Origin
    • 3.2.P.4.6 Novel Excipients

1 Separate 3.2.P.4 folder (with subfolders) for each excipient.

Figure C-4: MF Type IV – Drug Product

Figure C-4: MF Type IV – Drug Product. Text description follows
Figure C-4 Text Description

Figure C-4 displays a sample folder structure for a Master File Type IV regulatory activity. 

The Dossier Identifier should be "f" followed by seven numbers (MF number). 

  • Followed by, subfolder:
    • m11
  • Sub-subfolders:
    • 1.0 Correspondence
    • 1.0.1 Cover Letter
    • 1.0.3 Copy of Health Canada Issued Correspondence            
    • 1.0.4 Health Canada Solicited Information                        
    • 1.0.7 General Note to Reviewer
    • 1.1 Table of Contents
    • 1.2 Administrative Information            
    • 1.2.1 Application Form
    • 1.2.2 Fee Forms
    • 1.2.3 Certification and Attestation Forms            
    • 1.2.5 Compliance and Site Information            
    • 1.2.6 Authorization for Sharing Information                        
    • 1.2.7 International Information                                                                        
    • 1.3 Product Information
    • 1.3.6 Certified Product Information Document
  • Subfolder:
    • m2
  • Sub-subfolder:
    • 3 Quality Overall Summary2
  • Subfolder:
    • m3
  • Sub-subfolders:
    • 3.3.1 Table of Contents of Module 3                        
    • 3.2 Body of Data
    • 3.2.P Drug Product (AP)3
    • 3.2.P.1 Description and Composition of Drug Product            
    • 3.2.P.2 Pharmaceutical Development
    • 3.2.P.3 Manufacture
    • 3.2.P.4 Control of Excipients
    • 3.2.P.5 Control do Drug Product
    • 3.2.P.6 Reference Standards or Materials            
    • 3.2.P.7 Container Closer System
    • 3.2.P.8 Stability
    • 3.2.P Drug Product (RP)3
    • 3.2.P.1 Description and Composition of Drug Product
    • 3.2.P.2 Pharmaceutical Development
    • 3.2.P.3 Manufacture
    • 3.2.P.4 Control of Excipients
    • 3.2.P.5 Control do Drug Product
    • 3.2.A Appendices1
    • 3.2.A.1 Facilities and Equipment
    • 3.2.A.2 Adventitious Agents Safety Evaluation            
    • 3.2.A.3 Excipients
    • 3.2.R Regional Information1
    • 3.2.R.1 Production Documentation       

1 All documents in this folder will be considered Restricted Part (RP) of the MF.

2 Two separate documents should be submitted in the folder "2.3 Quality Overall Summary" a "QOS (RP)" and a "QOS (AP)" files.

3 (AP) or (RP) should be used in the subfolder names to identify if the folder is Applicants Part or Restricted Part.

  1.  All documents in this folder will be considered Restricted Part (RP) of the MF.
  2. Two separate documents should be submitted in the folder "2.3 Quality Overall Summary," a "QOS (RP)" and a "QOS (AP)" files.
  3. (AP) or (RP) should be used in the subfolder names to identify if the folder is Applicants Part or Restricted Part.

Appendix D: Distribution of master file information between the applicant and restricted parts

Table D-1: MF Type 1 - Drug Substance
Module/Folder Names Applicant's Part Restricted Part

Module 1: Administrative and Product Information

1.0

Correspondence

1.0.1

Cover Letter

-

1.0.3

Copy of Health Canada Issued Correspondence

-

1.0.4

Health Canada Solicited Information

-

1.0.7

General Note to Reviewer

-

1.1

Table of Contents

-

1.2

Administrative Information

1.2.1

Application Forms

-

1.2.2

Fee Forms

-

1.2.3

Certification and Attestation Forms

-

1.2.5

Compliance and Site Information

1.2.5.2

Establishment Licensing

-

1.2.5.5

Good Manufacturing Practices

-

1.2.6

Authorization for Sharing Information

-

1.2.7

International Information

-

1.3

Product Information

1.3.6

Certified Product Information Document

-

Module 2: Common Technical Document Summary

2.3

Quality Overall Summary (QOS)1

Module 3: Quality

3.1

Table of Contents of Module 3

3.2

Body of Data

3.2.S

Drug Substance

3.2.S.1

General Information

3.2.S.1.1

Nomenclature

-

3.2.S.1.2

Structure

-

3.2.S.1.3

General Properties

-

3.2.S.2

Manufacture

3.2.S.2.1

Manufacturer(s)

-

3.2.S.2.2

Description of Manufacturing Process and Process Controls

2

3

3.2.S.2.3

Control of Materials

-

3.2.S.2.4

Controls of Critical Steps and Intermediates

4

5

3.2.S.2.5

Process Validation and /or Evaluation

-

3.2.S.2.6

Manufacturing Process Development

-

3.2.S.3

Characterization

3.2.S.3.1

Elucidation of Structure and other Characteristics

-

3.2.S.3.2

Impurities

6

3.2.S.4

Control of Drug Substance

3.2.S.4.1

Specification

-

3.2.S.4.2

Analytical Procedures

-

3.2.S.4.3

Validation of Analytical Procedures

-

3.2.S.4.4

Batch Analyses

-

3.2.S.4.5

Justification of Specification

7

3.2.S.5

Reference Standards or Materials

-

3.2.S.6

Container Closure System

-

3.2.S.7

Stability

3.2.S.7.1

Stability Summary and Conclusions

-

3.2.S.7.2

Post-approval Stability Protocol and Stability Commitment

-

3.2.S.7.3

Stability Data

-

3.2.A

Appendices

3.2.A.1

Facilities and Equipment

-

3.2.A.2

Adventitious Agents Safety Evaluation

-

('' = Accepted  /  '-' = Not Applicable)

  1. A separate QOS for each part (AP / RP) or a single QOS to cover both parts can be provided, deleting all sections of the QOS not relevant to the MF. In cases when a single QOS is provided, the confidential business information/trade secret sections should be clearly identified.
  2. A flow chart (including molecular structures and all reagents/solvents) and a short description can be sufficient, if additional detailed information is presented in the Restricted Part. However, for sterile drug substances full validation data on the sterilisation process should be provided in the Applicant's Part (in cases where there is no further sterilisation of the final product).
  3. Detailed information
  4. Insofar as the information is also relevant for the applicant.
  5. Insofar as this information is not relevant for the applicant.
  6. Insofar as the information is related to the detailed description of the manufacturing process and the MF Owner sufficiently justifies that there is no need to control these impurities in the final drug substance.
  7. Insofar as the information is related to the detailed description of the manufacturing process, control of materials and process validation.
Table D-2: MF Type IV - Drug Products
Module/Folder Names Applicant's Part Restricted Part

Module 1: Administrative and Product Information

1.0

Correspondence

 

1.0.1

Cover Letter

-

1.0.2

Life Cycle Management Table

-

1.0.3

Copy of Health Canada Issued Correspondence

-

1.0.4

Health Canada Solicited Information

-

1.0.7

General Note to Reviewer

-

1.1

Table of Contents

-

1.2

Administrative Information

1.2.1

Application Forms

-

1.2.2.

Fee Forms

-

1.2.3

Certification and Attestation Forms

-

1.2.5

Compliance and Site Information

1.2.5.2

Establishment Licensing

-

1.2.5.5

Good Manufacturing Practices

-

1.2.6

Authorization for Sharing Information

-

1.2.7

International Information

-

1.3

Product Information

 

1.3.6

Certified Product Information Document

-

Module 2: Common Technical Document Summary

2.3

Quality Overall Summary (QOS)1

Module 3: Quality

3.1

Table of Contents of Module 3

3.2

Body of Data

3.2.P

Drug Product

3.2.P.1

Description and Composition of the Drug Product

3

3.2.P.2

Pharmaceutical Development

 4

3

3.2.P.2.1

Components of the Drug Product

5

3.2.P.2.2

Drug Product

-

3.2.P.2.3

Manufacturing Process Development

-

3.2.P.2.4

Container Closure System

-

3.2.P.2.5

Microbiological Attributes

-

3.2.P.2.6

Compatibility

-

3.2.P.3

Manufacture

3.2.P.3.1

Manufacturer(s)

3.2.P.3.2

Batch Formula

3.2.P.3.3

Description of Manufacturing Process and Process Controls

2

3

3.2.P.3.4

Controls of Critical Steps and Intermediates

4

6

3.2.P.3.5

Process Validation and /or Evaluation

-

3.2.P.4

Control of Excipients

4

6

3.2.P.4.1

Specifications

-

3.2.P.4.2

Analytical Procedures

-

3.2.P.4.3

Validation of Analytical Procedures

-

3.2.P.4.4

Justification of Specifications

-

3.2.P.4.5

Excipients of Human or Animal Origin

-

3.2.P.4.6

Novel Excipients

-

3.2.P.5

Control of Drug Product

3.2.P.5.1

Specifications

-

3.2.P.5.2

Analytical Procedures

-

3.2.P.5.3

Validation of Analytical Procedures

-

3.2.P.5.4

Batch Analyses

-

3.2.P.5.5

Characterization of Impurities

7

3.2.P.5.6

Justification of Specifications

8

3.2.P.6

Reference Standards or Materials

-

3.2.P.7

Container Closer System

-

3.2.P.8

Stability

3.2.P.8.1

Stability Summary and Conclusions

-

3.2.P.8.2

Post-approval Stability Protocol and Stability Commitment

-

3.2.P.8.3

Stability Data

-

3.2.A

Appendices

3.2.A.1

Facilities and Equipment

-

3.2.A.2

Adventitious Agents Safety Evaluation

-

3.2.A.3

Excipients

-

3.2.R

Regional Information

3.2.R.1

Production Documentation

3.2.R.1.1

Executed Production Documents*

-

3.2.R.1.2

Master Production Documents*

-

('' = Accepted  /  '-' = Not Applicable)

  1. A separate QOS for each part (AP/RP) or a single QOS to cover both parts can be provided, deleting all sections of the QOS not relevant to the MF. In cases when a single QOS is provided, the confidential business information/trade secret sections should be clearly identified.
  2. A flow chart (including all manufacturing steps, excipients and processing agents) and a short description can be sufficient, if additional detailed information is presented in the Restricted Part.
  3. Detailed information.
  4. Insofar as the information is also relevant for the applicant.
  5. Complete qualitative composition is provided to the applicant.
  6. Insofar as this information is not relevant for the applicant.
  7. Insofar as the information is related to the detailed description of the manufacturing process and the MF Owner sufficiently justifies that there is no need to control these impurities in the final drug product.
  8. Insofar as the information is related to the detailed description of the manufacturing process, control of materials and process validation.

Appendix E: UDRA table

The UDRA regulatory activity type should be used when there is no relevant regulatory activity defined in the Management of Drug Submission and Applications that can be used. A list of regulatory transactions that can be used for the UDRA activity type is provided in the Transaction Description document available on the Filing Submissions Electronically information page. Any other use of this regulatory activity type should be discussed with Health Canada prior to filing.

Table E-1: Regulatory transaction descriptions for UDRAs
Regulatory Transaction Description When to use description

Response to Advisement Letter

Rationale to not incorporate changes requested via advisement letter (to update the Product Monograph/ Prescribing Information)

Notification of Discontinued Sale *

When intending to cancel a DIN

Notification of Interruption of Sale *

When interrupting the sale of a product

Notification on Drug Shortage

When notifying Health Canada about a drug shortage, including
a request for Special Lot Release related to the drug shortage

* The indicated regulatory transactions should only be submitted in non-eCTD format if a dossier ID has been previously assigned, otherwise these transactions should be sent by email.

Appendix F: VDD folder structure

Please use the structure prescribed in "Appendix V: Master Index" of the Guidance document: Guidance for Industry Preparation of Veterinary New Drug submissions.

Section: 1.12 submission and product summary can be used to place documents such as PSUR, meeting package, meeting slides, meeting minutes, and drug notification form.

Figure F-1: example folder structure for a Veterinary Drug Pre-Submission Meeting Request transaction using REP

Figure F-1: example folder structure for a Veterinary Drug Pre-Submission Meeting Request transaction using REP. Text description follows
Figure F-1 Text Description

Figure F-1 displays an example of a folder structure for a Veterinary Drug Pre-Submission Meeting Request transaction using REP. 

The Dossier Identifier should be "v" followed by six numbers. 

  • Followed by, subfolder:
    • Part I: Requirements for Master Volume
  • Sub-subfolder:
    • 1.1 Cover letter
  • Document:
    • Pre-Submission Request.pdf
  • Sub-subfolder:
    • 1.5 Drug Submission Application
  • Document:
    • rt-v123456-2019-06-15-1045.xml

Figure F-2: example folder structure for a Veterinary Drug transaction for a Response to a Clarification Request using REP

Figure F-2: example folder structure for a Veterinary Drug transaction for a Response to a Clarification Request using REP. Text description follows
Figure F-2 Text Description

Figure F-2 displays an example of a folder structure for a Veterinary Drug transaction for a Response to a Clarification Request using REP.

The Dossier Identifier should be "v" followed by six numbers. 

  • Followed by, subfolder:
    • Part I: Requirements for Master Volume
  • Document:
    • Cover Letter.pdf
  • Sub-subfolder:
    • 1.5 Drug Submission Application
  • Documents:
    • rt-v123456-2019-04-10-1220.xml
    • pi-v123456-2019-03-08-0945.xml1
  • Sub-subfolder:            
    • 1.12 Submission and Product Summary
  • Documents:
    • Health Canada Issued Correspondence.pdf
    • Response Q and A document.pdf
  • Sub-subfolders:
    • Part II: Requirements for Manufacturing and Quality Control Format2
    • Part III: Requirements for Animal Safety2
    • Part IV Requirements for Efficacy2
    • Part V: Requirements for Human Safety2

1 when required

2 if applicable depending on the type of response

Figure F-3: example folder structure for a Veterinary Drug PSUR transaction using REP

Figure F-3: example folder structure for a Veterinary Drug PSUR transaction using REP. Text description follows
Figure F-3 Text Description

Figure F-3 displays an example of a folder structure for a Veterinary Drug PSUR transaction using REP. 

The Dossier Identifier should be "v" followed by six numbers. 

  • Followed by, subfolder:
    • Cover Letter
  • Document:
    • Cover Letter.pdf
  • Sub-subfolder:
    • 1.5 Drug Submission Application
  • Document:
    • rt-v123456-2020-05-25-1130.xml
  • Sub-subfolder:
    • 1.12 Submission and Product Summary
  • Document:
    • Product Safety Update Report.pdf

Figure F-4: example folder structure for a Veterinary Drug Post NOC Level III Changes Form Transaction using REP

Figure F-4: example folder structure for a Veterinary Drug Post NOC Level III Changes Form Transaction using REP
Figure F-4 Text Description

Figure F-4 displays an example of a folder structure for a Veterinary Drug Post NOC Level III Changes Form Transaction using REP

The Dossier Identifier should be "v" followed by six numbers. 

  • Followed by, subfolder:
    • m1
  • Sub-subfolder:
    • 1.2 Administrative Information
  • Sub-subfolder:
    • 1.2.1 Application Form
  • Document:
    • rt-v123456-2020-03-22-0630.xml
  • Sub-subfolder:
    • 1.2.8 Post-Authorization Information
  • Document:
    • Level III Changes Form.pdf

Appendix G: Common Electronic Submission Gateway (CESG)

The Common Electronic Submissions Gateway (CESG) is a method of securely providing regulatory transactions to Health Canada.

There are two methods for sending transactions:

  1. Using FDA Electronic Submission Gateway (ESG) Web Interface (WebTrader)
  2. Using Applicability Statement 2 (AS2) Gateway-to-Gateway

To determine which method best fits your company's business requirements, regulatory activity types, and infrastructure capabilities, please visit Section 3.5 of the FDA's User Guide.

This Appendix provides information on how to set up and use a WebTrader. If your company is considering an AS2, refer to FDA's User Guide.

FDA’s gateway website.

Step 1: Registering as a trading partner FDA

Registration is required for each WebTrader account and the account user will need to complete the FDA ESG registration process using the ESG Account Management Portal.

The Accounts Management Portal application has been developed to enhance Industry's user experience with onboarding external Electronic Submissions Gateway (ESG) accounts. It automates Industry account registration and approval process to streamline account onboarding and reduce onboarding time. It allows single access to multiple ESG environments and provides Account Management self‐service functionality such as password resets, certificate updates or uploads. It also allows Industry power users to manage user accounts and track submission status.

ESG Account Management Portal

ESG Account Portal User Guide

FDA has put together a convenient checklist, with the activities and requirements for companies preparing to setup a WebTrader account(s).

The registration steps are:

  1. Preparatory Activities
    • Read the following materials
      • ESG Account Management Portal User Guide
      • ESG User Guide
      • Tutorials
      • WebTrader System Requirements
    • Prepare an electronic Letter of Non-Repudiation Agreement
    • Obtain a Digital Certificate
  2. Register your WebTrader test account using the FDA ESG Account Management Portal
  3. Setup your computer for ESG
  4. Log in to the WebTrader Test website
  5. Send "test transaction" – Test transaction is required when setting up all new user accounts. You are required to send a TXT (sample.txt) file to the HC (Health Canada) center using your WebTrader test account (Figure G-1). The content of the TXT files are not reviewed. Once you send the TXT file, you should receive the following two messages:
    • The first is the Message Disposition Notification (MDN)
    • The second is the Acknowledgement containing the Message ID and the Core ID.
  6. Wait for FDA to migrate your account. FDA will review your test transaction and once approved, your account will be automatically migrated to the ESG production environment. This step may take up to 1 week for FDA to complete.
  7. After your test account is migrated, you are ready to send electronic transactions to Health Canada using the production ESG WebTrader application.

Note: The test transaction must not be sent via the production WebTrader application.

The WebTrader "Routing Information" fields for a test transaction should be filled out as below and as per figure G-1:

  • Recipient: FDATST
  • Center: HC
  • Submission Type: Transaction

Figure G-1:  WebTrader Information for sending a sample

Figure G-1:  WebTrader Information for sending a sample. text description follows.
Figure G-1 Text Description

Figure G-1 displays a screenshot of WebTrader 'Send document' tab for sending a sample.

Routing Information

Receipt: FDATST (pre-selected)

Center: "HC" (selected from picklist)

Submission Type: "Transaction" (selected from picklist)

Document Selection

Documents: 1 file has been selected

C:\Users\test.txt (location of the document)

Add document button and remove all documents button

Document Signing

Signing Certificate: C:\Users\certificate.p12 (location of signing certificate)

Password: ************** (hidden password)

Send button and Reset Button

The registration process is handled entirely by FDA, and therefore questions at this stage of the process should be directed to the FDA's Help Desk, at ESGHelpDesk@fda.hhs.gov.

Step 2: Sending transactions

After an account has been migrated to production, you may begin to send transactions to Health Canada.

  • Login to FDA Production WebTrader and navigate to the "Send Document" tab.
  • Fill out the "Routing Information" fields, as per below:
    • Recipient: FDA*
    • Center: HC
    • Submission Type: Transaction

 

*Important: once the test account has been migrated to production, the test account will also remain active and therefore each user can send transactions using the test gateway or production gateway. You will need to verify the Recipient information before sending your production transaction to ensure it is FDA. Health Canada is not checking the test environment, therefore any production transactions accidently sent via the test gateway (FDATST) will not be processed. 

  1. When selecting a document using the browsing tool, it is helpful to first place a temporary, ready to be sent copy of the whole transaction to a folder in an easy access location, such as your desktop. The top-level folder must be named with the "dossier ID" for the regulatory transaction (refer to figure G-2).

Below is a list of each dossier type and the lowercase letter associated with each type, along with the numeric digits to form the dossier ID:

Master Files (MF) Dossier ID: Lowercase letter 'f' followed by a seven-digit identifier (e.g. f1234567)

Medical Devices Dossier ID: Lowercase letter 'm' followed by a six-digit identifier (e.g. m123456)

Veterinary Drugs Dossier ID: Lowercase letter 'v' followed by a six-digit identifier (e.g. v123456)

Pharmaceutical / Biological Dossier ID: Lowercase letter 'd' (Div. 1) or 'p' (Div. 8) followed by a six-digit identifier (e.g. d123456 or p123456)

Figure G-2: examples of top level folders for various dossier types

Figure G-2: examples of top level folders for various dossier types. text description follows.
Figure G-2 Text Description

Figure G-2 displays an example of top-level folder for various dossier types

The Dossier Identifier for master files should be "f" followed by a seven-digit identifier (e.g. f1234567)

  • Followed by, subfolder:
    • m1
  • Sub-subfolder:
    • 1.0 Correspondence
  • Sub-subfolder:
    • 1.0.1 Cover Letter

The Dossier Identifier for medical devices should be "m" followed by a six-digit identifier (e.g. m123456)

  • Followed by, subfolder:
    • 1 REG ADMIN
  • Sub-subfolder:
    • 1.0.1 Cover Letter

The Dossier Identifier for Veterinary Drugs should be "v" followed by a six-digit identifier (e.g. v123456)

  • Followed by, subfolder:
    • Part I – Master Volume
  • Sub-subfolder:
    • 1.1 Cover Letter

The Dossier Identifier for Division 1 Pharmaceutical / Biological Drugs should be "d" followed by a six-digit identifier (e.g. d123456)

  • Followed by, subfolder:
    • m1
  • Sub-subfolder:
    • 1.0 Correspondence
  • Sub-subfolder:
    • 1.0.1 Cover Letter

The Dossier Identifier for Division 8 Pharmaceutical / Biological Drugs should be 'p' (Div. 8) followed by a six-digit identifier (e.g. p123456)

  • Followed by, subfolder:
    • m1
  • Sub-subfolder:
    • 1.0 Correspondence
  • Sub-subfolder:
    • 1.0.1 Cover Letter

Important considerations:

  • This step applies to all regulatory transactions; be it the first, or the sixth, seventh, eighteenth, etc. It is important to always create a copy of the regulatory transaction you wish to file, and paste just that one transaction inside a folder named with the appropriate dossier ID. Attaching a transaction from a folder containing multiple transactions will result in you sending them all to Health Canada, which will result in a failed transaction.
  • Information provided in previous transactions must not be provided again, unless it has been changed (i.e.: a MF update, MF letter of access, administrative change, response to NON, response to NOD, response to SDN, etc.).
  • Loose files sent via CESG are not accepted by Health Canada. Please refer to the guidance document applicable to your regulatory activity type for instructions on folder structure and file placement.
  1. Once you have located the folder named with the dossier ID, first click on the folder iconnot on the folder name, and after click the 'Select' button. Refer to the Figure G-3.

Important: Clicking on the folder name (dossier ID), instead of the folder icon, will drill down an extra level and will send the transaction to Health Canada without the top-level folder. Transactions received without a top-level folder will fail validation and the company will have to resend a corrected transaction via the CESG.

Figure G-3: Directory and File selection window

Figure G-3: Directory and File selection window. text description follows.
Figure G-3 Text Description

Figure G-3 displays a screenshot of Webtrader's Directory and File Selection window with arrow pointed to the folder icon next to the dossier ID x123456 and a square around the "Select" button

  1. After clicking the "Select" button, you will be redirected to the main "Send Document" tab. Here, you will be required to retrieve your Signing Certificate and enter you Certificate Password.

The figure G-4 is an example of how the "Send Document" should look when all the fields are populated.

Figure G-4:  WebTrader Information for sending a transaction

Figure G-4:  WebTrader Information for sending a transaction. text description follows.
Figure G-4 Text Description

Figure G-4 displays a screenshot of WebTrader 'Send document' tab for sending a transaction.

Routing Information

Receipt: FDA (pre-selected)

Center: "HC" (selected from picklist)

Submission Type: "Transaction" (selected from picklist)

Document Selection

Documents: 1 directory has been selected
C:\Users\x123456 (location of the document)
Add document button and remove all documents button

Document Signing

Signing Certificate: C:\Users\certificate.p12 (location of signing certificate)

Password: ************** (hidden password)

Send button and Reset Button

  1. When complete, click the "Send" button. You should then see a green bar that reads: "Your upload has been added to the queue. Completed uploads can be viewed in your "Sent Items" folder."
  2. From here, navigate to the "Sent Items" tab. You must wait to see 'Receipt' and '2 Acknowledgements' next to the Delivered indicator, as confirmation that your regulatory transaction has been received by Health Canada. Refer to figure G-5.

Figure G-5: Sent Items tab

Figure G-5: Sent Items tab. Text description follows
Figure G-5 Text Description

Figure G-5 displays a screenshot of WebTrader 'Sent Items' tab after Health Canada has received a regulatory transaction

The Status is 'Delivered' and the Document Name is 'x123456.tar.gz' with the delivery indicator 'Receipt' and '2 Acknowledgements'.

Note: If you do not receive the Receipt confirmation or either of the two Acknowledgements, after a few hours, please email the Health Canada eReview team, at ereview@hc-sc.gc.ca.

  1. If you wish to see the progress of your transaction at any point after sending it to Health Canada, you can verify on the Drug Submission Tracking System - Industry Access (DSTS-IA). Please do not email eReview about the status of your submission, as eReview does not handle submission status inquiries.

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