PMRA Guidance Document, Administrative Changes in Contact Information for Registered Pest Control Products (Registrants and Formulators)

Health Canada - Pest Management Regulatory Agency
17 February 2022
(PDF Version - 306 KB, 17 pages)

Document History

Updated:	Update/Rationale:
September 2021	Changes made to reflect current administrative practices
September 2005	Initial release of documents

Foreword

Guidance documents are meant to provide assistance to:

• Industry and end-users on how to comply with governing statutes and regulations, and/or
• Health Canada staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent, and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

Health Canada reserves the right to:

• request information or material,
• or define conditions not specifically described in this document,
• in order to allow the Department to adequately assess the safety, efficacy, or quality of a pest control product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

Related documents

This guideline should be read in conjunction with applicable notices and the relevant sections of applicable documents.

• Form 6026: Administrative Changes in Contact Information for Registered Pest Control Products

This guideline does not identify or establish requirements that are outside or in addition to current legislation. See the Pest control products (pesticides) acts and regulations section of the Canada.ca website for a list of all regulatory requirements.

Please note that this guidance document is in effect as of 17 February 2022 and should be used for applications submitted on or after 1 April 2020.

Table of Contents

• 1.0 Purpose
• 2.0 Registrant responsibility
• 3.0 Background
• 4.0 Scope
• 5.0 Policy
• 6.0 Contact roles
• 7.0 Requirements for administrative changes in contact information for registered pest control products (registrants and formulators)
  • 7.1 Requirements for a change in registrant name (Submission Category Y.1.1)
  • 7.2 Requirement for a change in registrant address (Submission Category Y.1.2)
  • 7.3 Requirements for a change (transfer) in registration ownership (Submission Category Y.1.3)
  • 7.4 Requirements for a change in Canadian representation (Submission Category Y.2.1) or a change in regulatory mailing address (Submission Category Y.2.2)
  • 7.5 Requirements for a change in formulator name (Submission Category Y.3.1)
  • 7.6 Requirements for a change in formulator address (Submission Category Y.3.2)
• 8.0 Registrant codes
• 9.0 Service standards
• 10.0 Fees
• 11.0 Marketplace labels
• 12.0 Requirement for e-PRS secure web portal enrollment
• 13.0 Implementation

1.0 Purpose

This document outlines the necessary steps that are required for current registrants in the event of an administrative change in registrant, change in formulator name or address, a change (transfer) of registration ownership, a change in Canadian representation - where applicable, or a change in regulatory mailing address.

This document is intended to provide guidance and supersedes the Regulatory Directive DIR2005-02, Administrative Process for a Change in a Registrant's Name or a Change in Registrant for Pest Control Products.

Related Form 6026: Administrative Changes in Contact Information for Pest Control Products.

2.0 Registrant responsibility

The term "Registrant" is defined under subsection 2(1) of the Pest Control Products Act as "a person in whose name a pest control product is registered." "Person" refers to a person in law, that is, a person or an entity created by law (for example, a corporation). A registrant must:

• be in a position to assume full legal responsibility for the pest control product registrations registered in its name;
• be able to comply with the conditions of registration for the pest control product registrations registered in its name; and
• be able to demonstrate legal entitlement to the pest control product registrations to be registered in its name.

In addition, registrants as per Subsection 3.1 of guidance document Notification/Non-Notification, registrants are responsible for maintaining up-to-date contact information. The Pest Management Regulatory Agency ("PMRA") must be informed of any changes to a registrant or formulator contact information.

3.0 Background

Improved record keeping and information tracking capacity enables the PMRA to streamline its efforts for accurate and reliable information. The PMRA strives for an efficient pest control product registration process.

In the event of a change in registrant or formulator name or address, regulatory mailing address or Canadian Representation or a change of registration ownership (transfer), a product registration must be amended to reflect these changes. Any changes must align and adhere to the Pest Control Products Act and Pest Control Product Regulations.

The PMRA meets the accepted target performance standards with regard to a change (transfer) in registration ownership requests. However, the processing of these requests has been compromised by:

• the practice of allowing other amendments to be processed in the same application, some of which require a review of the data and a re-categorization of the application
• the significant workload associated with transfers that resulting from mergers, spin-offs, buyouts, product-line purchases and other complex, sequential business transactions.

The transfer of a portfolio of products for these reasons, has often taken an additional two or more years for the PMRA to complete. Moreover, successive company mergers have resulted in an overlap of change requests and has created difficulties in record-keeping. This scenario has had a negative impact on the processing of other related applications and it has resulted in product labels for some registered products that incorrectly reflect the names of companies that have not existed for several years.

The procedures in Section 7.0 intend to address these issues.

4.0 Scope

This policy applies to all instances where there has been:

• a change occurs in the registrant name or address (provided that the registrant remains the same legal entity) (for example, an Amendment to the Certificate of Incorporation and the related Article of Amendment);
• a change occurs in registration ownership that results from a legal business transaction (for example, an amalgamation of companies, a spin-off of a new company, an acquisition of the rights to single or multiple registrations (for example, a buyout, product-line purchase)) or any other legal circumstance that entitles the new registrant to have registrations placed in its name;
• a change occurs in Canadian Representation or a regulatory mailing address (for example, a change to where the PMRA will direct the registrant's regulatory mail;
• a change occurs in the formulator name or address.

Note: The changes stated above cannot be processed for expired products.

5.0 Policy

Product-specific applications for notifications of a change in registrant or formulator name or address; a change in registration ownership (transfer); a change in regulatory mailing address; or change in Canadian Representation are no longer required. Instead, as an administrative process, current or proposed registrants, depending on the case, must submit an administrative change request comprised of the documentation outlined in Section 7.0 of this guidance. Then the PMRA will update all affected products listed on the Product Register to reflect the requested changes, and any open application. The procedures and documentation identified in Section 7.0 as a part of this administrative process, will be required to ensure that the change may be processed as requested.

The request to change a registrant's name or to transfer the registration ownership of pest control products should be submitted to the PMRA immediately following the completion of the business legal transaction (i.e., as soon as the applicable supporting documentation is available).

If current or proposed registrants desire to request any other changes to product registrations and/or corresponding product labels, they must submit the appropriate amendment application and/or notification.

6.0 Contact roles

Registrant contact: this individual is the intended or current registrant of the product, in whose name this application is filed, and in whose name the Certificate of Registration will be issued. The Registrant name must appear on the label. The address provided must be capable of receiving postal mail delivery.

When changing the Registrant contact, if the new contact is an employee of the Registrant, an email notification with new contact is sufficient.

Emails are to be sent to: pmra.reg.contacts-titu.arla@hc-sc.gc.ca.

Regulatory mailing address contact: this address is to where the PMRA will direct all regulatory mail. Operational and system requirements dictate that the regulatory mailing address must be the same for all products registered to the registrant. For non-Canadian registrants must use the Canadian Agent/Representative's mailing address. Note that under the Pest Control Products Act, all foreign registrants must name one Canadian representative, as the regulatory mailing address (address to where regulatory correspondence will be sent).

• When changing the Regulatory Mailing Address contact:
  • if the new contact is an employee of the Registrant, an email notification of the new name is sufficient;
  • if the new contact is not an employee of the Registrant, the Registrant must submit an application - refer to Section 7.4 : Requirements for a Change in Canadian Representation or a Change in Regulatory Mailing Address

Emails are to be sent to: pmra.reg.contacts-titu.arla@hc-sc.gc.ca.

Submission contact: this contact is to whom the PMRA will direct inquiries that are specific to the application. This role only lasts for the life of the submission. A letter of authorization (LOA), approving the submission contact to act on behalf of the registrant must be provided at the time of application to amend or register a pest control product.

7.0 Requirements for administrative changes in contact information for registered pest control products (registrants and formulators)

Prior to the submission of a change request, current or new registrants are strongly encouraged to contact the PMRA to clarify the identities of both the parties and products involved, and in advance determine any issues that may arise as a result of the change.

This procedure must be followed in the event of a change in registrant name for applications to register new products that have been received by the PMRA and are either awaiting review or are in progress: Submit follow-up correspondence under that submission number to request that the submission coordinator apply these changes under the submission number.

7.1 Requirements for a change in registrant name (Submission Category Y.1.1)

In the event of a change in registrant name (provided that the registrant remains the same legal entity), it is the responsibility of the registrant to submit a change request comprised of this documentation:

a. A cover letter on corporate letterhead that:

• confirms the contact information for the registrant;
• describes the circumstances surrounding the change;
• attests that no other changes aside from the change in registrant name have been made to the submitted product label(s) as compared to the last approved version of the label(s)
• confirms that the marketplace label of the affected products will be reprinted to reflect the new registrant within one year from the date the PMRA has acknowledged completion of the change request;

b. A signed, completed copy of the Form 6026: Administrative Changes in Contact Information for Registered Pest Control Products;

c. The amended English and French labels are to be available in separate Microsoft Word files of the last approved label for all affected products. Subsequently, submit ONLY the requested changes to the Registrant Name and address (if applicable) using the "Track Changes" tool. Changes not tracked or additional changes outside the nature of the request will be rejected. Consequently, new proposed labels may be required.

Note: When saving the labels in the PRZ file, indicate the Registration Number in the "TITLE" field;

d. A listing of:

• all affected products: Registration Number, Product Name, the most recently closed submission number for each product, from which the last approved label was obtained;
• all affected open applications that identify the submission number and corresponding product name;
• Supporting legal documentation which confirms the change in registrant name (i.e., copies of the Articles of Amendment and the Amendment to the Certificate of Incorporation/Modification)

e. In the case of private label registration(s), a letter from the current registrant of the initial product that supports the request for the change in registrant name for the private label registration(s).

The above documentation must be submitted in a PRZ file to PMRA via PMRA DOCS (pmra.docs.arla@hc-sc.gc.ca) or via the e-PRS Secure Web Portal (SWP).

If the submitted documentation is insufficient to support the change in registrant name, the PMRA will contact the registrant for additional information.

7.2 Requirement for a change in registrant address (Submission Category Y.1.2)

In the event of a change in registrant address where the registrant legal entity remains the same, it is the responsibility of the registrant to submit a change request comprised of this documentation:

a. A cover letter on company letterhead that:

• confirms the contact information for the registrant;
• describes the circumstances surrounding the change;
• attests that no other changes aside from the change in registrant address have been made to the submitted product label(s) as compared to the last approved version of the label(s);
• confirms that the marketplace label of the affected products will be reprinted to reflect the new registrant address within one year from the date the PMRA acknowledged completion of the change request;

b. A signed, completed copy of the Form 6026: Administrative Changes in Contact Information for Registered Pest Control Products;

c. The amended English and French labels are to be available in separate Microsoft Word files of the last approved label for all affected products. Subsequently, ONLY submit the requested changes to the registrant address using the "Track Changes" tool. Changes not tracked or additional changes outside the nature of the request will be rejected. Consequently, new proposed labels may be required.

Labels saved in the PRZ file must indicate the Registration Number in the "TITLE" field.

d. A listing of:

• all affected registered product(s): Registration Number, Product Name, the most recently closed submission number for each, from which the last approved label was obtained;
• all affected open applications that identify the submission number and the corresponding product name.

The above documentation must be submitted in a PRZ file to PMRA via PMRA DOCS (pmra.docs.arla@hc-sc.gc.ca) or via the e-PRS Secure Web Portal (SWP).

If the submitted documentation is insufficient to support the change in registrant address, the PMRA will contact the registrant for additional information.

7.3 Requirements for a change (transfer) in registration ownership (Submission Category Y.1.3)

In the event of a change (transfer) of registration ownership resulting from a business legal transaction, it is the responsibility of the new registrant to submit a change request comprised of the following documentation:

a. A cover letter on the new registrant company's letterhead that:

• confirms the contact information for the new registrant;
• describes the circumstances surrounding the change;
• attests that no other changes aside from the change in registrant contact information have been made to the submitted product label(s) compared to the last approved version of the label(s);
• confirms that the marketplace label of the affected products will be reprinted to reflect the new registrant within one year from the date the PMRA acknowledged completion of the change request;
• confirms that the proposed new registrant will comply with the conditions of registration for the affected pest control product registrations and will submit any outstanding data requirements;

b. A signed, completed copy of the Form 6026: Administrative Changes in Contact Information for Registered Pest Control Products;

• The amended English and French labels are to be available in separate Microsoft Word files of the last approved label for all affected products. Subsequently, submit ONLY the change in registration ownership and contact information using the "Track Changes" tool. Changes not tracked or additional changes that are outside the nature of the request will be rejected. Consequently, new proposed labels may be required.
  Labels saved in the PRZ file indicate the Registration Number in the "TITLE" field.

c. A listing of:

• all affected registered products: Registration Number, Product Name, the most recently closed submission number for each Product, from which the last approved label was obtained;
• all affected open applications that identify the submission number and the corresponding product name;

d. Supporting legal documentation which confirms that the new registrant:

• is in a position to assume full legal responsibility for the pest control registrations, and supply documents to confirm the proposed new registrant's status in law, (in other words, a Certificate of Incorporation/Modification)
• is legally entitled to the ownership of the products (for example, a copy of asset purchase agreement

e. In the case of private label registration(s), a letter from the current registrant of the initial product, that supports the request for a transfer of registration ownership for the private label registration(s).

In the event of a transfer of registration ownership that results from a legal business transaction, it is the responsibility of the current registrant to submit a cover letter on company letterhead that:

• describes the circumstances surrounding the change;
• lists all the affected registered products, according to registration number and their corresponding product name
• lists all affected open applications according to the application number and the corresponding product name
• confirms whether data ownership that relates to the affected pest control product registration(s) have been transferred to the proposed new registrant's profile.

The above documentation must be submitted in a PRZ file to PMRA via PMRA DOCS (pmra.docs.arla@hc-sc.gc.ca) or via the e-PRS Secure Web Portal (SWP).

If the submitted documentation is insufficient to support the transfer of registration ownership, the PMRA will contact the new registrant to discuss the documentation required by the PMRA to affect the transfer of registration ownership.

NOTE: All outstanding annual charges must be paid by the current registrant BEFORE the change (transfer) of registration ownership can be completed. Contact PMRA Receivables directly for information about Annual Charges and payment: pmra.receivable1-recevable1.arla@hc-sc.gc.ca.

*NOTE: Merger or Buyout

1. In the event of a registrant merger or buyout, all products that belong to the parties of the merger or buyout must be accounted for in the list of product registrations submitted with the change request. If one or more of the registrations acquired by the new registrant have been discontinued, the new registrant must comply with any conditions attached to the discontinuation until the registration expires. If there are any existing registrations that the new registrant does not wish to support, they must submit an Application for Renewal or Discontinuation (form 6000).
2. In the case of an amalgamation of two or more companies, each of whom hold pest control product registrations, a separate change request will be required for each of the registrant companies involved in the amalgamation.

7.4 Requirements for a change in Canadian representation (Submission Category Y.2.1) or a change in regulatory mailing address (Submission Category Y.2.2)

In the event of a change in the Canadian representative's name or address, or a change in the regulatory mailing address, it is the responsibility of the registrant to submit a change request comprised of this documentation:

a. a cover letter on the registrant company letterhead that:

• confirms the contact information for the new representative;
• describes the circumstances surrounding the change;
• in circumstances where the Canadian Representative or Regulatory Mailing Address appears on the product labels, an attestation that no other changes aside from the new representative and their contact information have been made to the submitted product label(s), compared to the last approved version of the label(s);
• in circumstances where the Canadian representative or Regulatory Mailing Address appears on the product labels, a confirmation that the marketplace label of affected products will be reprinted to reflect the new registrant within one year from the date the PMRA acknowledged completion of the change request;

b. a signed, completed copy of the Form 6026 Administrative Changes in Contact Information for Registered Pest Control Products;

c. A Letter of Authorization (LOA) for representation;

d. In some circumstances, the Canadian representative or Regulatory Mailing Address appears on the product labels. Subsequently, the amended English and French labels must be available in separate Microsoft Word files of the last approved label for all the affected products. The amendment must be restricted to ONLY the change in information for the representative contact information with the "Track Changes" tool. Changes that are not tracked, or additional changes that are outside the nature of the request will be rejected. Consequently, new proposed labels may be required.

Labels saved in the PRZ file must indicate the Registration Number in the "TITLE" field.

e. In circumstances where the Canadian representative or Regulatory Mailing Address appears on the product labels, a listing of:

• all affected registered products: their Registration Number, Product Name, and, the most recently closed submission number for each product, from which the last approved label was obtained
• all affected open applications that identify the submission number and the corresponding product name

The above documentation must be submitted in a PRZ file to PMRA via PMRA DOCS (pmra.docs.arla@hc-sc.gc.ca) or via the e-PRS Secure Web Portal (SWP).

If the submitted documentation is insufficient to support the change in Canadian representative or Regulatory Mailing Address, the PMRA will contact the registrant for additional information.

7.5 Requirements for a change in formulator name (Submission Category Y.3.1)

In the event of a change in the formulator name change, it is the responsibility of the registrant to submit a change request to advise of the most current formulator name for end-use products, and is comprised of this documentation:

a. A cover letter from either the registrant, regulatory mailing contact, or submission contact, that:

• confirms the contact information for the new formulator;
• describes the circumstances surrounding the change.

The above documentation must be submitted in a PRZ file to PMRA via PMRA DOCS (pmra.docs.arla@hc-sc.gc.ca) or via the e-PRS Secure Web Portal (SWP).

If the submitted documentation is insufficient to support the change in formulator name, the PMRA will contact the registrant for additional information.

7.6 Requirements for a change in formulator address (Submission Category Y.3.2)

In the event of a change in the formulator address, it is the responsibility of the registrant to submit a change request to advise of the most current formulator address for end-use products and is comprised of this documentation:

a. a cover letter from either the registrant, regulatory mailing contact, or submission contact, that:

• confirms the new address of the formulator/manufacturer;
• describes the circumstances surrounding the change.

NOTE: A change of address for the manufacturing address of a technical grade active ingredient (TGAI) pest control product registration does not qualify as an administrative change. Essentially, this type of change will require an application to register a new manufacturing site (Category B application). Refer to REG2003-01, Guidance on Selecting the Correct Category for Pest Control Product Submissions, or contact the Pest Management Information Service for assistance.

The above documentation must be submitted in a PRZ file to PMRA via PMRA DOCS (pmra.docs.arla@hc-sc.gc.ca) or via the e-PRS Secure Web Portal (SWP).

If the submitted documentation is insufficient to support the change in formulator address, the PMRA will contact the registrant for additional information.

8.0 Registrant codes

The PMRA keeps a record of registrant codes. If you do not know your registrant code, and if this code is necessary to submit your data as a 3rd party supplier, you can submit a request to: pmra.reg.contacts-titu.arla@hc-sc.gc.ca.

9.0 Service standards

The PMRA will proceed as follows in order to process change requests within 45 days. Upon receiving a change request, the PMRA will review the required documentation and determine whether it is acceptable. If the required documentation is determined to be acceptable, the PMRA will:

• a. update all the affected products listed in the Register and, if applicable, update the records for any open applications;
• b. confirm via email receipt of the PMRA's completion of the change request.

If the required documentation is determined to be unacceptable, the PMRA will move the submission status to "On-Hold" and contact the current or new registrant. They will explain to the registrant why the submitted documentation was determined to be unacceptable, and clarify the requirements. Consequently, the time required to fully process the request can exceed 45 days.

10.0 Fees

There are no fees associated with the process of Administrative Changes in Contact Information for Registered Pest Control Products (Registrants or Formulators).

11.0 Marketplace labels

After the PMRA has acknowledged the completion of a change in registrant name or a change (transfer) of registration ownership, the marketplace labels of all affected products must be:

• updated to reflect the change in registrant name or transfer of registration ownership;
• reprinted within one year from the date the PMRA acknowledged completion of the change request.

After reprinting the marketplace labels that reflect the change in registrant name or transfer of registration ownership, the registrant must either:

• over sticker or over label products in the distribution chain or marketplace bearing outdated labels, or
• advise retailers and users of the new contact information.

NOTE: There is no requirement to submit copies of reprinted labels to the PMRA at the time of reprinting.

12.0 Requirement for e-PRS secure web portal enrollment

a. When requesting a change to the existing primary officer, this information required:

• the e-PRS Secure Web Portal Terms and Conditions of Use Agreement; and
• Information Provider Profile Form.
  
  Subsequently, sign, date and send this information to: pmra.reg.contacts-titu.arla@hc-sc.gc.ca.

b. When requesting a new primary officer, this information is required:

• PMRA e-PRS Secure Web Portal Terms and Conditions of Use Agreement;
• PMRA Information Provider Profile Form; and
• Proof of legal capacity to enter into the e-PRS Secure Web Portal Terms and Conditions of Use Agreement (in other words, Certificate of Incorporation or business license).
  
  Subsequently, sign, date and send this information to: pmra.reg.contacts-titu.arla@hc-sc.gc.ca. Refer to this link for additional information regarding the Secure Web Portal enrollment

13.0 Implementation

This policy is in effect from the date on this guidance document.

• Current or new registrants should contact the Pest Management Information Service for additional information regarding Administrative Changes in Contact Information for Registered Pest Control Products (Registrant or Formulator).