ARCHIVED - Memo: Requirements and Expectations for Letters of Confirmation of Source of Supply

4 July 2008

1.0 Purpose

This memo clarifies the requirements of the Pest Management Regulatory Agency (PMRA) for submitting letters of confirmation of source of supply of active ingredient (LOC) for formulating registered pest control products.

This document provides minor clarifications requested by registrants and replaces the 13 April 2006 version.

2.0 Background

The requirements for LOCs have historically been equivocal. As a result, various styles of LOCs have been submitted as well as LOCs accompanied by letters of authorization for access to data and/or for representation. The PMRA frequently needs to seek clarification.

We wish to improve efficiency by simplifying the requirements for LOCs and reducing the need for clarification. We would also like to address the suggestions from industry regarding the need for consistent, effective and well-documented procedures.

To assist applicants and registrants when submitting LOCs, a sample letter has been included in the appendix.

3.0 Requirement for Letters of Confirmation of Source of Supply

The purpose of an LOC is to substantiate that registered pest control products are being used to provide the active ingredient(s) in the manufacture of formulated products. This also pertains to instances where a registered product is used as a preservative in the formulation of another pest control product. All pest control products must have the appropriate LOCs on file with the PMRA, and these LOCs must meet the acceptability criteria listed in Section 4.0. Note that LOCs on file with the PMRA are generally valid for five years from the LOC date, but the PMRA may request at any time that an updated LOC be submitted.

An updated LOC/set of LOCs is always required for the following:

• applications to add a new source of active ingredient to a product's formulation
• applications to obtain Master Product or Initial Product status
• reinstatement applications
• any application to register a new product (e.g. new Master Copy, new similar product)

LOCs will only be processed by the PMRA when they are directly related to an open submission, either as part of a new application package or in response to a specific PMRA request. When the LOC is requested by the PMRA for an open application, the submission number must be included in the letter (see example in Appendix A). When sending an LOC in response to a PMRA request, do not sent duplicate copies, that is, if the LOC is sent electronically, do not send the same LOC as a paper copy. This creates unnecessary work for the PMRA as each LOC received needs to be verified. Do not send LOCs to the PMRA at any other time.

The applicant must demonstrate its supply relationship with the registrant of the source of active ingredient or preservative. This can be done by providing a single LOC from the registrant of the product being used, or a set of LOCs connecting the registrant and applicant through a series of product distributors. It is not necessary to substantiate the supply relationship further than the registered product used to formulate the subject product (one step back requirement).

For example:

• Company A makes a technical class product and sells it to Company B.
• Company B formulates a manufacturing concentrate and sells it to Company C.
• Company C sells the product to Company D.
• Company D sells the product to Company E (the applicant).
• The applicant uses the manufacturing concentrate to formulate a commercial end-use product, and makes an application to the PMRA to register this end-use product.

To meet the LOC requirement for this end-use product, Company E (the applicant) must provide an LOC from Company B to Company E

OR

three LOCs, one each from B to C, C to D and D to E.

3.1 Exceptions to the Requirement for Letters of Confirmation of Source of Supply

3.1.1 An LOC is not required for submissions in which the registrant for the source of active ingredient and the applicant for the subject product are the same.

3.1.2 The PMRA has received an acceptable LOC within five years prior to the review. This exception does not overrule the requirement for LOCs for the submission types outlined in Section 3.0. Nor does it preclude the PMRA from requesting a new LOC at any time.

4.0 Criteria for Letters of Confirmation of Source of Supply

Each application must be supported by its own LOC or set of LOCs. For proposed new products, the LOCs must accompany the application. For amendment applications, reference may be made to the LOC(s) on file provided they continue to meet the criteria and the amendment application does not require an updated LOC as identified in Section 3.0.

An LOC will be deemed acceptable if it is on company letterhead, signed and contains ALL of the following information:

1. Legal name of the supplier of the source of active ingredient
2. Name and contact information of the supplier signing authority
3. Registered product name of the source of active ingredient
4. Pest control product registration number of the source of active ingredient
5. Legal name of the receiver to whom the active ingredient is provided

An LOC will be deemed unacceptable if any of the above is missing.

If the same registered product is used to manufacture more than one formulated product, we would prefer to receive a separate LOC for each of the resulting formulated products. This avoids confusion and keeps product-specific information in PMRA files clear.

Should a source of supply registrant (Registrant X) cease to supply a registered product to another registrant (Registrant Y) for manufacturing a formulated product, the formulated product registrant (Registrant Y) is responsible for submitting the appropriate documentation to the PMRA (e.g. an application to change the source of supply of the active ingredient, a registration discontinuation notice).

In addition, we request that applicants do not include letters of authorization in an LOC letter. Separate letters of authorization for access to data and/or for representation are required. Future publications will confirm the requirements for the various types of letters of authorization.

5.0 Implementation

This memo documents and clarifies the PMRA's current practices regarding requirements for letters of confirmation of source of supply and is effective as of the date of publication.

6.0 Questions

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

Appendix A

Sample Letter of Confirmation of Source of Supply

[Date]

[Chief Registrar/PMRA Officer]
Pest Management Regulatory Agency
2 Constellation Drive
Ottawa, ON K1A 0K9

Subject: Letter of Confirmation of Source of Supply (PMRA submission number)

This is to certify that [supplier name, address and contact information] supplies [receiver, address and contact information] with the following for the manufacture of products registered under the Pest Control Products Act.

Yours truly,

[Registrant signature]
[Printed signatory name and contact information]