Food and Drug Regulations

J.01.007.3 (1) The Minister shall refuse to issue, renew or amend a dealer’s licence if

• (a) the applicant is not eligible under section J.01.003.1;

• (b) an inspector who has requested an inspection has not been given the opportunity by the applicant to conduct an inspection under section J.01.025;

• (c) false or misleading information or false or falsified documents were submitted in or with the application;

• (d) an activity for which the licence is requested would not be in compliance with an international obligation;

• (e) information received from a competent authority or the United Nations raises a reasonable belief that the applicant has been involved in the diversion of a restricted drug to an illicit market or use or has been involved in an activity that was not in compliance with an international obligation;

• (f) the applicant does not have in place the security measures set out in the Security Directive in respect of an activity for which the licence is requested;

• (g) the applicant is in contravention of or has contravened during the preceding 10 years

  • (i) a provision of the Act or any regulations made or continued under the Act, or

  • (ii) a term or condition of another dealer’s licence or of an import or export permit issued to the applicant under any regulations made or continued under the Act;

• (h) the issuance, amendment or renewal of the licence would likely create a risk to public health, safety or security, including the risk of a restricted drug being diverted to an illicit market or use;

• (i) the individual in charge of the premises, the qualified person in charge or, if applicable, the alternate qualified person in charge has been convicted, as an adult, within the previous 10 years, of

  • (i) a designated drug offence,

  • (ii) a designated criminal offence, or

  • (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);

• (j) the proposed method referred to in paragraph J.01.007(1)(j) is not capable of recording the applicant’s restricted drug transactions as required under section J.01.023 or permitting the Minister to audit the applicant’s activities with respect to restricted drugs in a timely manner; or

• (k) the additional information required under section J.01.007.1 has not been provided or is insufficient to process the application.

(2) The Minister is not required to refuse to issue, renew or amend a licence under paragraph (1)(c) or (g) if the applicant

• (a) does not have a history of non compliance with the Act or any regulation made or continued under it; and

• (b) has carried out, or signed an undertaking to carry out, specified corrective measures to ensure compliance with the Act and these Regulations.