Food and Drug Regulations

Marginal note:Application for registration number

• J.01.006 (1) The manufacturer of a test kit may obtain a registration number for it by submitting to the Minister an application containing

  • (a) a detailed description of the design and construction of the test kit;

  • (b) a detailed description of the restricted drug and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component; and

  • (c) a description of the proposed use of the test kit.

• Marginal note:Signature and attestation

  (2) The application must

  • (a) be signed and dated by the person authorized by the applicant for that purpose; and

  • (b) include an attestation by that person that all of the information submitted in support of the application is correct and complete to the best of their knowledge.

• Marginal note:Additional information or document

  (3) The applicant must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.