Regulatory cooperation - Canadian guidance on veterinary drug simultaneous reviews with the United States: Submission filing

On this page

• Coordinated filing
• Electronic filing and submission format
• Filing date and administrative completeness
• Fees
• Data requirements
• Technical sections
• Unsolicited information
• Environmental data
• Submission plan

Coordinated filing

The sponsor must file data with both the Veterinary Drugs Directorate (VDD) and the U.S. Center for Veterinary Medicine (CVM) at the same time. The sponsor should let VDD know as soon as possible if they foresee any delays in filing. The sponsor will need to obtain agreement to ensure the late filing does not affect the simultaneous review process.

The sponsor must send in a submission plan when they file their submission. The sponsor should also send in an updated submission plan when they file subsequent data packages.

Electronic filing and submission format

Use electronic tools, such as the Regulatory Enrolment Process (REP), to send in submissions to VDD.

Submissions should be in electronic-only format. For reference, please refer to the following guidance document:

• Preparation of drug regulatory activities in the non-eCTD electronic-only format

VDD will place the submission on process hold if:

• the submission does not follow this format
• the file path name is too long or
• the forms are missing or not signed

We recommend that sponsors use 1 of the following 2 format options for the RCC pathway:

1. organize all data according to the folder structure within the Canadian drug registration framework
   • please consult the following:
     • folder structure for veterinary drugs' zip file (refer to the Non-eCTD format only section of Filing submissions electronically webpage)
     • Preparation of drug regulatory activities in the non-eCTD electronic-only format
2. submit the files using the U.S. file submission structure as follows:
   • submit a crosswalk to the Canadian table of contents that clearly indicates the location of the information and highlights country-specific deviations
   • name the main folder with the dossier ID number
   • name the subfolder using the CVM submission identifier, which includes the 8-character INAD number before the P/G/H-submission number
   • make sure the folder and file names are meaningful

Option 2 is preferred as it opens up discussions between regulators and reduces the chance of missing documents.

Sponsors should discuss how they will file their submission at the pre-submission meeting.

Filing date and administrative completeness

The Canadian official filing date is when a submission is deemed administratively complete. This is when all elements and forms required for processing are completed and have been submitted to Health Canada. This date may differ from the date of original receipt should the submission or application be considered administratively incomplete at that time.

If the information received in a submission does not meet all applicable administrative requirements, the submission will be placed on process hold. Examples of not meeting the requirements include:

• non-eCTD electronic-only format was not followed
• file path name is too long
• forms are missing or incomplete

The sponsor is not required to submit all sections in order for the submission to be considered administratively complete if the requirements of C.08.002(8) or C.08.003(8) have been met. For a submission to be considered administratively complete, it must contain at least the following elements:

• submission certificate and
• a major data package

When submitted within the REP, you must use the following file:

• REP regulatory transaction (RT) file and REP product information (PI) file

To meet the requirements of C.08.002(8) or C.08.003(8):

• the Minister must have indicated an intent to conduct a review of the submission with the CVM
• there is a submission plan
• some or all of the information required under any of the paragraphs C.08.002(2)(d) to (h), (m) and (n) (a major data package) is included
• there must be a drug identification number for the drug that is being referenced as a direct or indirect comparison (if applicable)

A major data package means a technical section that contains 1 of the following:

• a description of the plant and equipment to be used in manufacturing, preparing and packaging the new drug (C.08.002(2)(d))
• details of the method of manufacture and the controls to be used in manufacturing, preparing and packaging the new drug (C.08.002(2)(e))
• details of the tests to be applied to control the potency, purity, stability and safety of the new drug (C.08.002(2)(f))
• detailed reports of the tests made to establish the human or animal safety of the new drug for the purpose and under the conditions of use recommended (C.08.002(2)(g))
• substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended (C.08.002(2)(h))
• evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production (C.08.002(2)(m)) or
• the withdrawal period of the new drug (C.08.002(2)(n)) administered to food-producing animals

For details on specific document requirements for each major data package, consult:

• Guidance for industry preparation of veterinary new drug submissions

The contents of a major data package are similar to the contents of a CVM P submission.

Fees

The sponsor should not include payment when they file a technical section. We will verify and adjust the fee, and issue an invoice if applicable.

When we invoice depends on the nature and timing of receipt of the technical sections. Invoicing typically occurs in stages after the last technical section of the clinical, quality or human safety sections are accepted for review.

For more information on the fee process, consult the following guidance document:

• Fees for the review of veterinary drug submissions and applications

VDD encourages sponsors to confirm applicable Canadian fees before they submit. For updated fee amounts, refer to:

• Veterinary drug submission application and fee form

Data requirements

The content in the submission sent to VDD should be the same as the content in the U.S. submission. Any documents required by CVM, including administrative documents, must also be submitted to us.

Submissions to VDD must meet all applicable Canadian regulatory and administrative requirements. For more information on the specific administrative requirements for veterinary drug submissions, consult:

• Guidance for industry preparation of veterinary new drug submissions, Part I: Requirements for master volume

There may be additional or different data requirements that are specific to Canada only.

Note that all Canada-specific data requirements for new drug submissions (NDS) and supplements still apply to drug submissions under the Regulatory Cooperation Council (RCC) pathway. Examples of data requirements include the certified product information document (CPID) and quality overall summary (QOS).

For more information, refer to the relevant guidance documents:

• Guidance documents – Legislation and guidelines – Veterinary drugs

Technical sections

Sponsors should submit technical sections to VDD with the related “acknowledgement of receipt” from CVM.

Unsolicited information

Information that is not required by VDD can be submitted as part of the drug submission but must be labelled “unsolicited information” and accompanied by a summary description. While VDD may look at any provided unsolicited information, we do not review the information for its compliance with the regulations.

Examples of unsolicited information include a memorandum of conference, a technical section complete letter and a technical section incomplete letter.

Environmental data

Submissions that include environmental data help us assess the potential risk to the environment and human health from environmental exposure to substances in veterinary drugs under the Canadian Environmental Protection Act, 1999 (CEPA).

For more information and guidance on environmental data and requirements under CEPA, email the Environmental Assessment Unit at eau-uee@hc-sc.gc.ca.

Environmental data that is not specifically solicited by VDD may be submitted as “unsolicited information”, along with a brief description of the information.

Submission plan

A sponsor should submit a submission plan with the request to participate in the RCC pathway. The plan should specify when the sponsor intends to provide the missing information and consider a scenario where the sponsor cancels the submission.

Sponsors must submit an up-to-date submission plan at the time of initial filing.