Component Checklist for Veterinary New Drug Submissions

Table of Contents

Covering letter clearly indicating
Drug Submission Application Form HPB 3011
Labelling
Product Name
Fee and Fee Application Form
Table of Contents
Submission Certification
Letter of Authorization
Patent List
Submission Format
Master Volume
Phased submissions
Additional Data

Note: this checklist has been created to assist you in completing your veterinary drug submission, it is not a complete list of the data required. It does not replace the requirements of the Food and Drugs Act and Regulations.

The following information should be included in all veterinary drug submissions:

Covering letter clearly indicating:

• product trade name
  
  
• purpose of the submission
  
  
• number of volumes included (originals and duplicates). Each separate binder of information is considered to be a "volume"; these are to be numbered sequentially (ie. 1 to 15)
  
  
• for phased submissions include the submission number and file number previously assigned
  
  
• letter to be dated and signed, with the name and position of the signee to be clearly indicated, as well as the full company address and telephone/fax numbers

Drug Submission Application Form HPB 3011:

(This form can be viewed in either HTML format or PDF format)

• must be signed and dated
  
  
• number of volumes indicated in Part 1, Section 6
  
  
• company name (Part 1, Section 12) is the company who will own the DIN
  
  
• formulation must match the manufacturing information and be consistent with labelling

Labelling:

• product name to be same as that indicated on form HPB 3011
  
  
• labelling text must be in one or both official languages
  
  
• labelling to be provided for each dosage form, and package size; package insert to be included, if applicable
  
  
• a total of two copies of each label should be provided

Product Name:

• must be the same name on labelling and in Drug Submission Application Form HPB 3011. The correct Canadian product name (not just the chemical name) should also be included in the covering letter and in the data; if a different product name is used in the data, this should be clearly explained

Fee and Fee Application Form:

(This form can be viewed in either HTML format or PDF format)

• Veterinary Drug Submission Fee Application Form (cover page and appropriate section(s) only) and applicable fee must be included with submission
  
  
• a photocopy of the original form is acceptable
  
  
• Cheques are to be made payable to the "Receiver General for Canada" in Canadian funds from a Canadian bank
  
  
• applications for reduced fees must include the $1000 application
  fee plus the calculated reduced fee (Part 5.2 of the Guidance
  Document on Cost Recovery)

Table of Contents:

• to be included in the Master Volume
  
  
• all components/subsections identified by volume and page
  
  
• non-applicable sections identified (if there is no data, please do not include a "volume" for a non-applicable section or component)

Submission Certification:

• to be executed by an officer of the Company
  
  
• to be signed by a Canadian Authorized Agent, if applicable

Letter of Authorization:

• must be included for a submission cross-referenced to a submission of another company

Patent List:

• include new Patent Form IV or V (June 1998)
  
  
• a copy of the labelling and information about the chemical composition of the product, along with the original Patent forms, is sent by VDD to the Patent Officer, Submission and Information Policy Division (SIPD), Therapeutic Products Programme

Submission Format :

• for all submissions, the purpose is clearly stated in the covering letter
  
  
• for additional data (A/D) submissions, specify the number of volumes included and also enclose a copy of the letter from the VDD which requested the data.

Master Volume:

• should contain the covering letter, Submission Certification, Table of Contents, Drug Submission Application Form HPB 3011, Fee Application form (and payment), Letter(s) of Authorization (allowing reference to a submission owned by another company), draft labelling and information about prior submissions
  
  
• 2 copies of the Master Volume should be submitted for submissions for veterinary drugs used in non-food animals.
  
  
• copies of the Master Volume should be submitted for submissions for veterinary drugs used in food-producing animals (one for each of the applicable reviewing units: Manufacturing, Pharmaceutical Assessment, and Human Safety)
  
  
• two copies (original and duplicate) of the rest of the submission are to be submitted in separate volumes for separate components ie. manufacturing data Part 2, separate from Human Safety data Parts 3 & 4, apart from Efficacy & Animal Safety data Parts 5 & 6
  
  
• duplicate volumes readily distinguished from original
  
  
• the volume covers (front cover and spine) should be identified by volume number (numbered sequentially), manufacturer, product name, date, and component
  
  
• Table of Contents for each volume, cross-referenced by volume # and page #
  
  
• pagination (sequential or by volume) consistent throughout
  
  
• legibility of text and graphics (clarity, type size)
  
  
• 3-ring binders (not accupress binders) should be used for submissions with more than 20 pages. Binders should not fall apart nor be too thick
  
  
• 6 cm margins (except annotations) for Comprehensive Summaries
  
  
• for submissions for a veterinary drug used in a food-producing animal, human safety data is required (for NDSs, some SNDSs). Human safety data may also be required for some DIN applications for not-new-drugs (ie. residue data for intra-mammary drug products)

Phased submissions :

• a summary should be included indicating the purpose and rationale of the phased submission, and an estimate of when the subsequent phases will be submitted
  
  
• the Drug Submission Application Form HPB 3011 and draft labelling are to be included with the first component(s) submitted. A photocopy of this information should be included with the components sent in each subsequent phase.
  
  
• Part 5: Intended Species Safety Studies and Part 6: Efficacy Studies must be submitted in the same phase as they are evaluated together.
  
  
• Part 3: Laboratory Animal Toxicity Studies must be submitted at the same time as either Part 4 or Parts 5 and 6 as it is relevant to the evaluation of each of these Parts.

Additional Data :

All subsequent requested data and unsolicited information will also be verified or screened to ensure that it includes all information requested or is relevant (if unsolicited). Sponsors should clearly identify in a covering letter the product name, submission number, and file number of the relevant submission, the purpose of the correspondence and the amount of data included. A copy of the letter from the VDD which requested the additional data should be enclosed. The requested information should be submitted in a question and answer format which is cross-referenced to replacement volumes where appropriate.

Revised December 14, 2001