Pub: 210717
Name and address:
Telephone #:
Email:
1.
2.
3.
4. Indications (claims) including intended species:
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Product Classification RequestForm
Veterinary Drugs Directorate (VDD)
This form is to request a
product classification
from the Veterinary Drugs Directorate (VDD), who acts as a single-window
for product classifications, when it is unclear how a product for use in animals is to be regulated. Please note that the
information below is requested for classification purposes only and should not be considered an official submission for
product approval.
Please note: The information provided may be shared with other government departments and agencies responsible for
other product types for discussion and classification purposes.
Complete this form and submit with supporting documentation by email at: [email protected]. If more space
is required, or additional product information needs to be submitted, include it in the email.
Section B: General Product Information
Section A: Requester Information
Product Name:
Company Name and Address:
Purpose/Intent of use:
Tablets Capsules Chewable tablets Granules Powder Soluble Powder
Solution ConcentrateSuspension Cream Ointment Shampoo
Other (specify):
7. Mode of action (as documented or postulated):
8. Complete directions for use and/or dosage recommendations:
9.
10. Any other product information considered to be relevant:
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2 | Product Classification Request Form
Regulatory status of this product ininternational jurisdiction(s), with links to authorizations or proof/evidence
(e.g.European Medicines Agency (EMA), European Food Safety Authority (EFSA), Australian Pesticides and
Veterinary Medicines Authority (APVMA), Food and Drug Administration (FDA), Association of American Feed
Control Officials (AAFCO),etc.):
5. Product form:
6. Mode of administration:
Added to pet food or livestock feed
Added to drinking water
Direct (forced) oral administration
Parenteral
Topical
Other (specify):
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Section C: Detailed Product Information
1 a) Product formulation/composition
-
Ingredient name
Ingredient Purpose
Ingredient
Identification
3
Substance ID
4
Ingredient #
5
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3 | Product Classification Request Form
Quantity
and
units
2
Inactive
ingredients
Active
ingredients
Ingredient
type
1
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1
Ingredient type: chemical, feed, plant, plant extract, microorganism or other
2
Quantity and units: units in %, mg/kg, or mg/L
3
Ingredient identification: CAS no. if chemical, Latin name if plant, bacterial strain if microorganism
4
Substance ID: as indicated on List of Permitted Substances (LPS) for Veterinary Health Products, if applicable
5
Ingredient #: in Feeds Regulations Schedule IV or V, Part I
1 b) For any ingredients that are plant extracts
Extract
Extraction Ratio
Crude
Equivalent
Short Description of Manufacturing Process
1 c) For any ingredients that are essential oils
Essential oil
Complete Formulation (% pure essential oil, % any other oil, etc.)
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4 | Product Classification Request Form
-
Ingredient name
Ingredient Purpose
Substance ID
4
Ingredient #
5
Inactive
ingredients
Ingredient
type
1
Quantity
and units
2
Ingredient
Identification
3
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Section D: Information to provide
Attach the following supporting documents (if available) to the form and submit to classification-vet@hc-sc.gc.ca:
Copy of the proposed label
Copy of any supporting material, including promotional (with source of the publication)
For each section, supporting documentation and references
Research documentation (including source) pertaining to each active ingredient
List of comparable (similar) products (with labels)
Information about the regulatory status of similar products
Supporting documentation from a regulatory authority
Veterinary Drugs Directorate (VDD)
Email: classification-vet@hc-sc.gc.ca
Website: Classification of products for use in animals
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5 | Product Classification Request Form
2022/06/23
