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Pest Control Products Regulations (SOR/2006-124)

Regulations are current to 2023-01-25 and last amended on 2022-12-07. Previous Versions

Protection of Test Data (continued)

Application

Marginal note:Equivalent active ingredients

 Sections 17.1 and 17.3 to 17.94 apply to applications to register a pest control product whose active ingredient has been determined by the Minister under subsection 7(2) of the Act to be equivalent to the active ingredient of a registered pest control product.

  • SOR/2010-119, s. 2
  • SOR/2016-61, s. 2

Marginal note:Re-evaluations and special reviews

 Sections 17.1, 17.2 and 17.4 to 17.94 apply, with any necessary modifications, to a registrant who wishes to use or rely on test data of another registrant for the purpose of subsection 16(5), (5.1), 18(3) or (3.1) of the Act.

  • SOR/2010-119, s. 2
  • SOR/2017-169, s. 2

Marginal note:Non-application — product copies

 When an applicant wishes to use or rely on test data of a registrant in order to register a pest control product that is equivalent to the registrant’s product, using a pest control product provided by that registrant, sections 17.5 to 17.94 do not apply if

  • (a) the registrant provides the Minister with a letter of confirmation of source; and

  • (b) the only pest control product used in the manufacture of the applicant’s product is the one provided by that registrant.

  • SOR/2010-119, s. 2

Exclusive Use

Marginal note:Exclusive use period

  •  (1) The registrant of a new active ingredient has the exclusive use of the following test data for 10 years after the date of registration:

    • (a) test data that was provided in support of the initial application to register the active ingredient;

    • (b) test data that was provided in support of a concurrent application to register a pest control product that contains that active ingredient; and

    • (c) test data that was included in any additional information that was reported to the Minister under section 12 of the Act in relation to those applications.

  • Marginal note:Exclusive use — compounds and substances

    (2) The registrant of a new pest control product described in paragraph 2(b) has the exclusive use of the test data submitted in support of the initial application to register it, for 10 years after the date of registration, if the product has never been an ingredient in a registered pest control product.

  • Marginal note:Extension — minor uses

    (3) The Minister must extend the exclusive use period in all of the following circumstances:

    • (a) the registrant

      • (i) includes minor uses in an application to register a pest control product referred to in paragraph (1)(b), or

      • (ii) on or after August 1, 2007 but in any case within seven years after the date of registration of a pest control product referred to in paragraph (1)(b), either makes an application to amend that registration to add minor uses or makes an application, that includes minor uses, to register a new pest control product that contains the same active ingredient;

    • (b) the registrant requests an extension of the period, within eight years after the date of registration; and

    • (c) the Minister determines that the proposed minor uses are minor uses, as defined in section 17.1, and approves their addition to the registration.

  • Marginal note:Calculation of extension

    (4) The following rules apply when calculating an extension:

    • (a) the exclusive use period is extended by one year for every three minor uses that are added, one or more at a time, to the registration for a maximum total period of 15 years; and

    • (b) the maximum number of minor uses in respect of a crop group is the number of representative crops in the crop group.

  • Marginal note:When minor use withdrawn or removed

    (5) Each extension of one year is cancelled if the registrant withdraws a minor use from their registration, or the Minister amends the registration and removes a minor use, such that the remaining number of minor uses is insufficient to support the extension.

  • SOR/2010-119, s. 2
  • SOR/2016-61, s. 3

Marginal note:Letter of access

 During the exclusive use period, an applicant may use or rely on test data of a registrant in an application to register a pest control product or amend a registration if the registrant provides the applicant with a letter of access.

  • SOR/2010-119, s. 2

Agreements

Marginal note:Conditions — use or reliance

  •  (1) Subject to subsection 17.94(2), an applicant may use or rely on compensable data of a registrant if they pay compensation to the registrant in accordance with an agreement for the relevant period described in subsection (2) and provide the Minister with a copy of a letter of access.

  • Marginal note:Compensable period

    (2) Compensation is payable in respect of the following compensable data that is submitted to or considered by the Minister for the first time, for the following periods:

    • (a) in the case of test data that supports an application to register a pest control product whose active ingredient is already registered, for 12 years after the date of the application;

    • (b) in the case of test data that supports an application to amend a registration, for 12 years after the date of the application;

    • (c) in the case of test data submitted in response to a notice delivered to the registrant under subsection 16(3), 18(1) or 19(1) of the Act, for 12 years after the date on which the Minister receives the data; and

    • (d) subject to subsection (3), in the case of foreign test data considered by the Minister in the course of a re-evaluation or special review, for 12 years after the date on which the Minister initiates the re-evaluation or special review.

  • Marginal note:Condition — foreign test data

    (3) Foreign test data is compensable only if the registrant is able to provide the Minister with the foreign test data on request.

  • SOR/2010-119, s. 2

Marginal note:Minister to identify compensable data

  •  (1) For the purpose of subsection 7(2) of the Act, the Minister must provide the applicant with a list of the compensable data that they may use or rely on and in respect of which they will need to enter into an agreement with each registrant.

  • Marginal note:Request to enter agreement

    (2) On receipt of the list of compensable data, the applicant may send a copy of an agreement to the registrant to enter into with respect to such of that data that they wish to use or rely on, by certified or registered mail or any other method of delivery that provides proof of delivery.

  • SOR/2010-119, s. 2
  • SOR/2017-169, s. 3

Negotiation and Arbitration

Marginal note:Agreement entered into

  •  (1) On delivery of the proposed agreement, the applicant and the registrant must enter into the agreement and begin to negotiate the compensation payable in respect of the data that the applicant wishes to use or rely on.

  • (2) [Repealed, SOR/2016-61, s. 4]

  • Marginal note:Negotiation

    (3) If the parties fail to reach a negotiated settlement with respect to the compensation payable within 120 days after delivery of the agreement, they may continue negotiating if they both agree to do so.

  • SOR/2010-119, s. 2
  • SOR/2016-61, s. 4

Marginal note:When no negotiated settlement — notice of arbitration

  •  (1) If the parties fail to conclude a negotiated settlement in accordance with section 17.9, the applicant may, by notice in writing delivered to the registrant, submit the determination of the compensation payable to binding arbitration in accordance with the agreement.

  • Marginal note:Parties’ offers in writing

    (2) The notice must include the last offers of the parties, if they were presented in writing at the end of the negotiation.

  • Marginal note:Method of delivery

    (3) The notice must be delivered by certified or registered mail or any other method of delivery that provides proof of delivery.

  • Marginal note:Arbitral award

    (4) An arbitral award must be made within 120 days after delivery of the notice, unless

    • (a) the parties agree to an extension of that period; or

    • (b) the arbitrator provides written notice to the parties, before the end of that period, that the period has been extended.

  • SOR/2010-119, s. 2
  • SOR/2017-91, s. 6

Marginal note:When no offer in writing

 If the registrant does not put their last offer in writing at the end of the negotiation, the applicant may make the request referred to in subsection 17.93(1) without having to meet the conditions set out in section 17.93.

  • SOR/2010-119, s. 2

Marginal note:Conditions on early registration

  •  (1) If a negotiation ends without a negotiated settlement, the applicant may, once a notice referred to in section 17.91 has been delivered, use or rely on the compensable data and request that the Minister register their product in the absence of a letter of access, if the following conditions are met:

    • (a) the applicant enters into an escrow agreement with a third party;

    • (b) the third party is a person who is entitled under the laws of a province to receive and hold money on behalf of another person;

    • (c) pursuant to the escrow agreement, the applicant deposits with the third party an amount of money equal to the registrant’s last offer referred to in subsection 17.91(2); and

    • (d) the escrow agreement contains all of the following terms:

      • (i) the third party holds the money until it is payable in accordance with the escrow agreement,

      • (ii) on receipt of a copy of the registration certificate, the third party pays the registrant an amount equal to the applicant’s last offer referred to in subsection 17.91(2),

      • (iii) on receipt of a copy of the negotiated settlement or arbitral award, the third party pays the registrant the amount determined in that settlement or award, less the amount paid under subparagraph (ii), and

      • (iv) the third party pays any remaining balance to the applicant.

  • Marginal note:Copy and proof to Minister

    (2) The applicant must send the Minister both a copy of the escrow agreement and proof that the applicant has deposited the money with the third party in accordance with paragraph (1)(c).

  • SOR/2010-119, s. 2

Marginal note:Letter of access

  •  (1) On the determination of the compensation payable, whether by negotiated settlement or arbitral award, the registrant must provide the applicant with a letter of access in accordance with the settlement or award.

  • Marginal note:Failure to provide letter of access

    (2) If the registrant fails to provide the letter of access, the applicant may use or rely on the compensable data without having to comply further with the negotiated settlement or arbitral award.

  • SOR/2010-119, s. 2

Emergency Registration

Marginal note:Validity period and exemption

 Despite section 13, if a pest control product is registered for, or the registration of a pest control product is amended to permit its use in, the emergency control of a seriously detrimental infestation,

  • (a) the validity period must not be longer than one year and may not be extended;

  • (b) subsections 28(1) and 35(1) and paragraphs 42(2)(c) to (f) of the Act do not apply; and

  • (c) the registration may not be renewed.

 [Repealed, SOR/2022-241, s. 10]

Denaturation

Marginal note:When required

 If the physical properties of a pest control product are such that its presence may not be detected when it is used and as a result it could expose a person or domestic animal to a severe health risk, the pest control product must be denatured by means of colour, odour or any other means specified as a condition of registration by the Minister under paragraph 8(1)(a) of the Act to provide a signal or warning as to its presence.

  • SOR/2014-24, s. 9(E)

Advertising

Marginal note:Prohibition

 A word or an expression that states or implies that the Government of Canada or any of its departments or agencies promotes, endorses or recommends the use of a pest control product must not appear on the package of, or in any advertisement for, a pest control product.

  • SOR/2014-24, s. 10(F)

Labels

General

Marginal note:Official languages

  •  (1) Subject to subsection (3), all information on a label must be in both English and French.

  • (2) [Repealed, SOR/2014-24, s. 11]

  • Marginal note:Exception — products destined abroad

    (3) The information on the label of a registered pest control product that is not authorized to be manufactured, imported, sold or used in Canada may be in either English or French, or in both.

  • SOR/2014-24, s. 11

Marginal note:Label — presentation

  •  (1) All information that is required to be shown on a label must appear in a manner that is clearly legible and indelible.

  • (2) Any written, printed or graphic matter on the marketplace label of the pest control product must not detract from or obscure the required information.

  • SOR/2018-284, s. 4

Marginal note:Diseases of humans

  •  (1) A label must not represent a pest control product as a treatment, preventive or cure for any disease, disorder or abnormal physical state listed in Schedule A.1 to the Food and Drugs Act.

  • Marginal note:Diseases of domestic animals

    (2) A label must not represent a pest control product as a treatment, preventive or cure for any disease, as defined in subsection 2(1) of the Health of Animals Act, that is required to be reported under that Act.

Display Panel

Marginal note:Principal and secondary display panels

 A registered pest control product must have a display panel consisting of a principal display panel and a secondary display panel.

 
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