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.
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)
| 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 |
Page details
- Date modified: