Submission Completeness Checklist for Fertilizer or Supplement Registration Applications: Me-too
A complete submission package must include all the information requirements as indicated below and must be organized in the form of sections or tabs as per the Guide to Submitting Applications for Registration Under the Fertilizers Act.
Mandatory List of Tabs and Sub-Tabs
Tab 1: Administrative Forms and Fees (Required for Safety Assessment Levels I, II, and III)
- Cover letter stating that the company guarantees that the "me-too" label and product are exactly the same as the currently registered product label apart from either:
- name or address of the registrant and/or manufacturer;
- colour or format of the label;
- product name and/or brand; and/or
- declaration of net contents (weight).
- A letter from the initial registrant granting permission to CFIA to use the data in the original parent file to support the me-too registration.
- Completed and signed Fertilizer or Supplement Registration Application (CFIA/ACIA 3778) form according to the Guidelines to Completing the Fertilizer or Supplement Registration Application Form document.
- Designation of Signing AuthorityFootnote 1
- Designation of Delegated Representatives (optional)Footnote 1
- Declaration of Resident Canadian Agent (required if the applicant/registrant does not reside in Canada) (Please ensure that the Canadian Agent signs and completes applicable section of the registration form)Footnote 1
- Registration Fee
Tab 2: Marketplace Label (Required for Safety Assessment Levels I, II, and III)
- Proposed Market Place Label
Tab 3: Product Specification (Required for Safety Assessment Levels I, II, and III)
- List of Ingredients: Input MaterialsFootnote 1 (preferably in table-format; always include Name of the material, CAS# (if available), Manufacturer, Country of origin, Source, Manufacturing/purification processes, Concentration in the final product, Purpose, and (M)SDS)
- List of Ingredients: Microbial Inocula, when product contains viable microorganism (always include purpose of the microroganism; its taxonomic identification to the strain level if possible; analytical results; relationship to known pathogens; strain bank accession number or environmental isolate's origin/proof of purity)Footnote 1
- List of Ingredients: Composition of the Final ProductFootnote 1 (preferably in table-format; always include Identity of the ingredient, Relative proportion as w/w percentage of the final product, and (M)SDS)
- Method of ManufactureFootnote 1
- Quality Assurance and Quality Control ProceduresFootnote 1
- Physical CharacteristicsFootnote 1
Tab 4: Results of Analysis (Required for Safety Assessment Levels II and III)
- Total number of batches/lots produced within a 3 year period (if applicable)
- Sets of Metal Analyses as required
- One (1) set of Dioxins and Furans (if applicable; provide with new product application only)Footnote 1
- Four (4) sets of Indicator Organisms (if applicable)
Please note that requirements vary depending on the product type. (Consult Appendix 2 of the guide in order to determine which Tabs are required for each product.)
The Fertilizer Safety Section reserves the right to require additional information, data, fees, rationale or results of analysis to support the registration of any product regulated under the Fertilizers Act and Regulations.
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