Food and Drug Regulations

Marginal note:Qualified person in charge

• J.01.012 (1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to restricted drugs that are specified in the licence application and for ensuring that those activities comply with this Part. The applicant may designate themself if the applicant is an individual.

• Marginal note:Alternate qualified person in charge

  (2) An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual.

• Marginal note:Qualifications

  (3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:

  • (a) they work at the site specified in the dealer’s licence;

  • (b) they

    • (i) are a person entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician,

    • (ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or

    • (iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold

      • (A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or

      • (B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province;

  • (c) they have sufficient knowledge of and experience with the use and handling of the restricted drugs specified in the dealer’s licence to properly carry out their duties; and

  • (d) they have sufficient knowledge of the provisions of the Act and this Part that are applicable to the activities specified in the dealer’s licence to properly carry out their duties.

• Marginal note:Exception

  (4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if

  • (a) no other individual working at the site meets those requirements;

  • (b) those requirements are not necessary for the activities specified in the licence; and

  • (c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties.