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Requirement for the submission of a statement of product specifications form (SPSF) - Canada.ca
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Requirement for the submission of a statement of product specifications form (SPSF)
2014-04-14
1.0 Purpose
The purpose of this document is to communicate changes regarding the requirement for the submission of an SPSF with all applications to register, amend, conduct research with, or renew pest control products. Implementation of these changes has been designed to improve process efficiencies for both registrants and the PMRA.
2.0 Background
The Formulants Policy (DIR 2006-02; Formulants Policy and Implementation Guidance Document) requires that all applications to register, amend, conduct research with, or renew pest control products include SPSFs regardless of whether the purpose of the application involves changes to the SPSF. This requirement was established to ensure that the PMRA had up-to-date product specifications that reflected the current product composition.
As the requirement for submission of an SPSF for registration renewal was in place from 2002 until 2011, up-to-date SPSFs should now be on file with the PMRA for most products.
3.0 Scope
The changes described in this document apply only to certain product amendments. Applications to register new products and amendments involving changes to an SPSF will continue to require the submission of an SPSF.
Statement of Product Specification Form instructional video
4.0 Changes to the requirement for submission of SPSFs
For product amendments, the submission of an SPSF with an application to amend a product registration will only be required if the amendment involves a change to the SPSF(s). Refer to Appendix A for a list of submission types which require an SPSF.
For pest control product amendment applications not involving the submission and review of an SPSF, (e.g., label revisions) the validity period for the registration will only be extended for a period up to December 31st of the fifth year after the year in which the amended registration is granted, if the registrant attests that no changes have been made to the product SPSF(s) since they were last approved by the PMRA. In such instances, the following statement must be included within the covering letter for the application.
"I, the undersigned, certify on the basis of direct knowledge that no changes have been made to the pest control product SPSFs for [insert product name and registration number] since they were last approved by the PMRA"
The PMRA may conduct an audit of product SPSFs for products that have not undergone a recent SPSF review by the PMRA (e.g., in the last 5 years) by requesting the submission of SPSFs during the review of the application for product amendment or under a separate application.
5.0 Effective Date
These process changes will be in effect on April 1, 2013.
6.0 Questions/Contact
Any questions on the new process should be directed to the
PMRA Information Service
.
Appendix A Submission categories requiring the submission of a Statement of Products Specification Form (SPSF)
Submission categories requiring the submission of a Statement of Products Specification Form (SPSF)
Category
Subcategory
Description
SPSF required?
A
New technical grade active ingredient (TGAI)
Canadian registration
Yes
User requested minor use registration (URMUR)
Yes
Import maximum residue limits (MRLs)
Foreign product SPSF required
Major new use
Major new use - end use product (EP)
Required if new product
Major new use - technical grade active ingredient (TGAI)
No
B
New/changes to TGAI or Integrated systems product (ISP) product chemistry
New source/site
Yes
Specifications
Yes
New/changes to EP or manufacturing use (MA) product chemistry
Guarantee
Yes
Form of TGAI or ISP
Yes
Identity of Formulants
Yes
Proportion of Formulants
Yes
Formulation Type
Yes
New combinations of TGAIs
Yes
New/changes to product labels
Application rate increase
No
Application timing
No
Application number or frequency
No
Application Method
No
Rotational crops/plantback interval
No
Pre-harvest/pre-slaughter/with-holding interval
No
Pre-grazing interval
No
Re-entry interval
No
Level of control
No
Tank mixes
No
New pests
No
New site or host
No
Precautions
No
Classification
Required if new registration number assigned
Category C "fast track" submissions (i.e., Category B submissions requiring only Part 10 Value data) as described in Regulatory Note REG2002-04, Category C Submission Efficacy Reviews
No
Conversions or extensions of conditional registration
Conversion from conditional to full registration
Required if new data results in Changes to the SPSF
Renewal of conditional registration
No
Fulfilment of conditions of registration for a product with full registration
Required if new data results in changes to the SPSF
Partial submission of data for conditionally registered product
Required if new data results in changes to the SPSF
New MRL
New MRL for previously assessed TGAI
No
Registration reinstatement
Reinstatement of product registration
Yes
C
New/changes to TGAI or ISP product chemistry
New source /site
Yes
Specifications
Yes
New/changes to EP or manufacturing use (MA) product chemistry
Guarantee
Yes
Form of TGAI or ISP
Yes
Identity of formulants
Yes
Proportion of formulants
Yes
Formulation Type
Yes
New/changes to product Labels
Application rate decrease
No
Application timing
No
Application number or frequency
No
Application method
No
Rotational crops/plantback interval
No
Pre-harvest/slaughter/with-holding interval
No
Pre-grazing interval
No
Re-entry interval
No
Level of control
No
Tank mixes
No
New pests
No
New site or host
No
Precautions
No
Classification
Required if new registration number assigned
Re-evaluation-related label revisions
No
NAFTA label
No
Administrative changes
Change/addition of source of registered TGAI
Yes
Addition of approved minor use
No
New product
Registration of a similar product
Yes
Upgrade to master or initial product status
Yes (Note: requirements will change under revised Notification/Non-notification Policy)
D
User requested minor use label expansion (URMULE)
New use
No
Fast track registration
Master copy registration
Yes
Private label registration
No
Renewal
Renewal of product registration
No
E
Research permits
New TGAI
Yes
New Use
Required if new EP or new formulation
Notification of Research
Required if new TGAI, new EP or new formulation
F
Notification
Notifiable Changes under DIR2001-04
No (Note: requirements will change under revised Notification/Non-notification Policy)
P
Pre-submission consultation
Presubmission consultations for new TGAIS, ISPs, MAs, and EPs, joint reviews, product amendments, study protocols
Required for new products and changes in specifications
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Date modified:
2020-12-04