Memorandum to Registrants, Applicants and Agents - Category C Guidance Document

19 May 2010

Purpose

This document provides guidance on the requirements for a Standard Category C application and clarifies the review process for these submissions by the Pest Management Regulatory Agency (PMRA). The information supplements REG2003-01: Guidance on Selecting the Correct Category for Pest Control Product Submissions.

Background

The PMRA has defined a Category C application as a submission with no or reduced data requirements for new or amended registrations requiring minor label or formulation reviews (DIR2003-01: Organizing and Formatting a Complete Submission for Pest Control Products).

This document refers specifically to applications with no data requirements (referred to as a Standard Category C). Guidance on Category C applications with reduced data requirements is provided in REG2002-04: Category C Submission Efficacy Reviews.

To qualify as a Standard Category C application, the following criteria must be respected:

• The source of active ingredient used to formulate an end-use product or manufacturing concentrate must be registered in Canada.
• The information on formulants¹ and formulant mixtures² used in the manufacture of pest control products must be acceptable to the PMRA (i.e., complete information on the formulant or formulant mixture has been provided to the PMRA).
• Requests for waiver of data requirements cannot be considered under a Standard Category C application. Additionally, waivers should not be included as part of the covering letter of the application.

To provide a more efficient process and facilitate a common understanding of Standard Category C applications and their review, the PMRA would like to:

• clarify the requirements for acceptance of an application for consideration as a Standard Category C application; and
• provide more information for those Category C subtypes that require PMRA review.

Appropriateness of a Precedent Product for a Standard Category C Application

An appropriate precedent product is required for several types of Standard Category C applications (e.g., a similar product). Table 1, Overview of Standard Category C Application Types, indicates which types of applications specifically require that a precedent product be cited. The onus is on the applicant to provide a valid precedent that best supports their application.

Definition of a Precedent Product

A precedent product is a pest control product that is currently registered in Canada.

Selecting a Suitable Precedent Product

To help the applicant identify a suitable precedent product, the following criteria must be met:

• A maximum of two precedents may be cited to support an application. For situations where two precedent products are required to support the application, the applicant must explain in their cover letter how each of the precedent products supports the application.
• The precedent product must be equivalent (substantially similar) to the proposed product. Differences may be acceptable if they are deemed to have no adverse implications for product quality or biological activity such as safety, residues or efficacy.
• Products with a conditional registration may be cited as a precedent for a new or amended registration
• If the cited precedent product was itself registered as a similar or identical product, the PMRA will not consider it an appropriate precedent product for a Category C application.

In addition to the above criteria, there may be regulatory issues that the PMRA will consider when validating the appropriateness of the cited precedent product.

Eligibility Criteria for a Standard Category C Application

To clarify the requirements for different Standard Category C applications and how the PMRA reviews them, the PMRA has stratified the different Standard Category C types under four broad common types:

1. New registrations (i.e., issuing a new Pest Control Product Registration Number)
2. Amendments to an existing registration
3. PMRA required amendments
4. Administrative changes

Table 1 provides an overview of Standard Category C application types and highlights the expectations for each of these broad groups of Standard Category C applications with respect to the label and the formulation of the proposed product. The requirement for a precedent product in support of the application is also indicated.

A. New Registrations

Identical Products

To be considered identical to a registered precedent product, the proposed product must meet all of the following criteria:

• the source of active ingredient(s) must be identical.
• the formulation must be identical.
• the label text (i.e., uses) must be the same as the cited precedent.

The above criteria apply only to new end-use products and manufacturing concentrates. New technical grade active ingredients (TGAIs) must be manufactured in the same manufacturing plant as the precedent product (i.e., they are a re-pack of the precedent product). The applicant must also submit a Letter of Authorization to Cite Data from the registrant of the TGAI.

Similar Products

To be considered similar to a registered precedent product, the new proposed product must meet all of the following criteria:

• the active ingredient(s) must be registered by PMRA.
• the active ingredient(s) must be the same concentration (i.e., within the standard certified limits).
• the formulation type must be the same.
• the chemical and physical properties are similar.
• the formulant(s) must be equivalent and at equivalent concentrations with the same functionality. Differences may be acceptable if they are deemed to have no adverse implications for product quality or biological activity such as efficacy, safety or residues.
• the label text (i.e., uses) may contain all, or a subset of, the use claims found on the cited precedent.

The above criteria apply only to new end-use products and manufacturing concentrates. As previously described, Category C applications to register a new TGAI must always be identical to the precedent product.

B. Amendment to an Existing Registration

Standard Category C application amendments to an existing registration can consist of either a minor label or a minor formulation change. Whenever a label or a formulation change is made through a Standard Category C application, the onus is on the applicant to explain, in their cover letter, what change is being proposed, why the change is being proposed and to confirm why the proposed change(s) will not have an effect on either the chemical or biological aspects of the product. For formulation amendments, the PMRA will compare the proposed changes to the original formulation specifications in order to prevent a potential drift in product specifications.

Please note that the maximum number of amendments allowed under one application is five (5). The following information provides an overview of what constitutes an amendment.

Examples of an amendment are as follows:

• Amendment of the net content range.
• Addition of a tank mix.
• Addition of a use (e.g. cooling towers, addition of wheat/canola) based on the equivalence to an existing registered product.
• Addition of a pest.
• Addition of an alternate formulation.

An applicant would be able to make five (5) amendments per application. An application could include:

• Addition of one alternate formulation.
• Addition of two pests.
• Addition of one tank mix.
• Addition of a one use.

Likewise, an application could also include:

• Addition of one pest.
• Addition of four tank mixes.

Minor Label Changes

Standard Category C label changes are limited to those supported by a precedent product or those that are editorial in nature. Some examples of this type of application are described below:

Addition of a New Pest or New Site

For this type of application, the proposed product label must be based on a precedent product and meet all of the following criteria:

• the active ingredient(s) must be the same and be registered by PMRA.
• the rate of application must be the same.
• the formulant(s) must be the same or equivalent and at the same or equivalent concentrations with the same functionality.
• the formulation type should be the same.
• no expansion of the currently registered use pattern.

Addition of a Tank-Mix Partner

A tank-mix, by definition, is the simultaneous use of two or more registered pest control products in a single application. Standard Category C applications to add a tank-mix are based entirely on precedent products according to the following criteria:

• all components of a tank mixture must be currently registered;
• there is no expansion of the use pattern (i.e., both partners are registered on the same site);
• the tank-mix use is already on one of the component's product label;
• the tank-mix use is on the label of a product which has an identical or similar formulation with that of the proposed product (Note: the covering letter should state the submission number under which this may have been previously assessed and accepted);
• the tank-mix use has already been approved in the format of a supplemental label, and the application is to incorporate the tank-mix use to the full product label.

Minor Formulation Changes

Minor formulation changes refer to small amendments to the concentration(s) of the formulant(s) or the substitution of a similar formulant (i.e., a formulation with the same functionality) with another. Some examples of this type of application are described below:

Change in the Identity of Formulants

The applicant's covering letter must outline all of the proposed formulation amendments and must provide assurances that both the chemical and biological aspects of the product will not be affected as a result of the amendment.

• the active ingredient(s) must be the same and be registered by PMRA.
• the active ingredient(s) must be the same concentration (i.e., within the approved certified limits).
• the formulant(s) must be the same or equivalent and at the same or equivalent concentrations with the same functionality. Differences may be acceptable if they are deemed to have no adverse implications for product quality or biological activity such as efficacy, safety or residues.
• the formulation type must be the same.

Change to the Guarantee

For this type of application, the guarantee of the active ingredient in the proposed amendment must remain within its certified limits as approved by the PMRA.

C. PMRA - Required Amendment to an Existing Registration

These types of applications refer to label recommendations and/or formulation changes that are initiated by the PMRA following the development of a new policy or as a result of a re-evaluation decision.

Periodically, the PMRA publishes policy documents that require the registrant to amend their product. When submitting an application to comply with these policy documents, the cover letter must outline the policy document number. Unless otherwise stated in the policy document, no other changes can be made with this type of application.

In the case of a re-evaluation decision, the application must reflect the label improvement or formulation change that is requested in the PMRA re-evaluation document. In addition, the changes proposed in the application must be limited to the re-evaluation decision (i.e., no other changes to the product are to be made at this time). This is to ensure efficient processing of the application.

D. Administrative changes

These types of Standard Category C applications include, but are not limited to, reinstatements, a change of source of registered active and a request for Master Product status. Some examples of this type of application are described.

Reinstatements

An applicant can submit a Standard Category C application for the reinstatement of an expired product registration if:

• the application is submitted within 12 months of the expired registration date;
• there are no changes to the label and to the formulation; or in the case of a TGAI, there is no change in the manufacturing site and specifications;
• the product contains a registered active ingredient;
• all appropriate, updated Letters of Confirmation of Source of Supply (LOC) are included; and
• the product was not discontinued or cancelled as a result of a re-evaluation decision by PMRA.

Please note that a Category B application is required to reinstate a product where the registration has lapsed for more than 12 months.

Change of Source of Registered Active Used in the Formulation of a Registered Product

For this type of application, the application must fulfill all of the following criteria:

• the source of new active must be registered by PMRA.
• an LOC for each source of active ingredient (new and original sources) must be included with the application.

Upgrade to Master/Initial Product Status

A product which has a master product registration status can be used as a precedent for registration of subsequent copies (Refer to DIR93-20: Master Product/Master Copy Registration Process and DIR93-21: Initial Product/Private Label Registration Process.) This type of application must be accompanied by an appropriate, updated LOC for each source of TGAI found in the product.

An Initial Product status must be issued before an application to register a Private Label will be accepted for review. Initial Product status can only be granted to fully registered products that are not manufacturing concentrates or TGAIs. Private Label products must be identical in formulation and must be formulated on the same production line as the Initial Product.

Data Protection

Regulatory Directive DIR2007-03: Protection of Proprietary Interests in Pesticide Data in Canada (PPIP) describes the PMRA's new data protection policy that relates to the TGAI, the manufacturing concentrate and end-use products. It explains which type of data is protected and for how long. The PPIP may be applicable to Standard Category C applications where the applicant and the registrant of the cited precedent are different. Should the precedent product be supported by protected data from a different registrant, the applicant will have to gain access to it through PPIP unless:

1. The applicant has previously gained access to the data and has provided evidence of this (e.g., a letter of access);
2. The applicant has a LOC from the registrant of the precedent product or is applying to register a master copy or private label; or
3. The use being cited is a tank mix which already includes the applicant's product (e.g., Registrant's A label has a tank mix with Registrant's B product, so registrant B can add the same tank mix on its own product's label)

The PMRA will publish guidelines for the registration of generic (i.e., a new product based on a precedent) manufacturing concentrates and end-use products in the near future. Information on the implementation of this policy for Standard Category C applications will be detailed in subsequent communications.

Ineligibility Criteria of a Standard Category C Application

Before making a Standard Category C application, it is important to recognize the circumstances under which such an application would not meet the eligibility criteria for a Standard Category C application. Reasons for ineligibility include, but are not limited to:

• the new or amended product contains an active ingredient or source of active ingredient that is not currently registered in Canada. Guidance on these active ingredients is outlined in the Notice to Registrants: Pest Control Products Containing Active Ingredients or Sources of Active Ingredients that are Not Currently Registered in Canada (July 2004).
• the new or amended product is one of the following product types: an antifouling paint, an antisapstain, preservative used in millwork or joinery products, and preservatives used in textiles or treated articles. All formulation changes, however minor, to these product types require a Category B application.
• the new or amended product contains a new formulant, defined as a "formulant not currently identified as being present in a registered Canadian pest control product."
• the labelling of the new or amended product proposes differences in the precautionary statements compared to the precedent product. The precautionary symbols of the new or amended product must be the same as the precedent product unless the change has been requested by PMRA.
• the new or amended product proposes the substitution of a chemically dissimilar carrier/solvent for a product that is sprayed on crops, without a suitable precedent.
• the new or amended product proposes the addition of a bittering agent to a vertebrate-control bait product, without a suitable precedent.

Review Time Lines for Standard Category C Applications

The review time for a Standard Category C application is 45 days for screening and up to 180 days for evaluation (as per PRO96-01: Management of Submission Policy). The PMRA is currently reassessing review times for all subtypes. Once this review is completed, it is anticipated that the PMRA will be in a position to propose changes to the review times of some subtypes of Standard Category C applications.

Preparation of a Standard Category C Application

The Agency's ability to meet its commitment to review a Standard Category C application within the MOSP time frame will depend on the quality of the application and the completeness of the submitted information (e.g., completeness of required forms). Applicants are reminded to consult DIR2006-05: Requirements for Submitting Data Index, Documents and Forms for submitting documents in support of a Standard Category C application.

The required forms should be downloaded from the web:

• Form 6003: Statement of Product Specification Form
• Form 6005: Application for New or Amended Registration
• Form 6011: Fee Form
• Form 6023: Proposed New Uses and/or Uses to be Withdrawn from the Label

The following documents apply to Standard Category C applications and should also be consulted:

• June 1, 2006: Memorandum - Transparency Requirements of the new Pest Control Products Act: New Requirements for Applications to Register or Amend a Pest Control Product
• July 4, 2008: Memorandum - Requirements and Expectations for Letters of Confirmation of Source of Supply
• February 14, 2003: REG2003-01: Guidance on Selecting the Correct Category for Pest Control Product Submissions
• October 28, 1993: DIR93-20: Master Product/Master Copy Registration Process
• October 28, 1993: DIR93-21: Initial Product/Private Label Registration Process
• April 11, 2003: DIR2003-01: Organizing and Formatting a Complete Submission for Pest Control Products
• June 15, 2006: DIR2006-05: Requirements for Submitting Data Index, Documents and Forms

Questions

Questions concerning the clarified requirements should be directed to the PMRA via the Pest Management Information Service

Table 1 - Overview of Standard Category C Application Types

Purpose of application	Product Type	Parameters for PMRA Review			Examples
		Precedent Required	Label	Formulation
A. New Registration
Identicali.e., repack	TGAI MA EP	Yes	Identical to the precedent product label	Identical to the precedent product	Company A wants to register a new product that has the same uses and formulation as Company B's product that is currently registered.
Similar or "me-too"	EP MA	Yes	Identical to precedent product label, or subset of the precedent product label	Similar to the precedent product	Company A wants to register a new product that has similar uses and formulation as Company B's product that is currently registered.
B. Amendment to an Existing Registration
Label Change
New pests, new site/host	EP	Yes	All of the amendments must be present on the precedent product.	Identical or similar to the precedent product	Company B wants to amend the label to include a new pest for Product B to match the label of Company A's Product A. Both products contain the same active ingredient at the same guarantee and rate of application
Addition of a tank mix partner	EP	Yes	All of the tank mixes must be present on the precedent product	Identical or similar to the precedent product	Company A wants to add a tank mix between its Product A and Company B's Product B where the Product B product label currently has this tank mix
Formulation Changes (Product Chemistry Changes)
Changes in the identity and/or proportions of the formulants	EP MA	No	Only if the changes require any additional labelling statements (e.g., the addition of a formulation preservative)	Similar to original formulation No changes in the value or toxicology profile as a result of the changes	Company A wishes to add a formulation preservative to Product A
Changes to the guarantee	EP MA TGAI	No	Yes	Guarantee remains within the [standard] certified limits of the original formulation	Company A wants to decrease (or change from min to nom) the guarantee in Product A and the proportions of existing formulants have been adjusted to compensate for the change in guarantee
C. PMRA - Required Amendments
Re-evaluation triggered label changes	EP MA TGAI	No	Must reflect the changes requested in PMRA re-evaluation decision letter	Identical to the original formulation	The re-evaluation decision letter to registrants provides details related to their product(s)
Label Policy Changes	EP MA TGAI	No	Must reflect the changes requested in PMRA memo	Identical to the original formulation
Formulation Changes	EP MA	No	Identical to the original label	Must reflect the changes requested in PMRA memo and be limited to those changes	The removal of formulants of concern
D. Administrative Changes
Reinstatement of a previously registered product (expired within last 12 months)	EP MA TGAI	No	Identical to the original label	Identical to the original formulation
Change of source of registered active used in formulation	EP MA	No	Identical to the original label	Similar to original formulation Source of new active must be registered by the PMRA	Company A currently has two sources of active ingredient but wants to add a third registered source
Upgrade to Master/Initial Product Status	EP	No	Identical to the original label	Identical to the original formulation	Refer to DIR93-20: Master Product/ Master Copy Registration Process or DIR93-2, Initial Product/ Private Label Registration Process