Human Pathogens and Toxins Regulations

Marginal note:Period during which licence in effect — factors

• 2 (1) When determining the period during which a licence is in effect, the Minister must take the following factors into consideration:

  • (a) the history of the applicant’s compliance, during the previous 10 years, with the provisions of the Act and the regulations, the Department of Health Act, the Human Pathogens Importation Regulations, the Health of Animals Act and the Health of Animals Regulations;

  • (b) the risks associated with the controlled activities authorized by the licence; and

  • (c) any other factor that is relevant to the protection of the health or safety of the public.

• Marginal note:Maximum period

  (2) The maximum period during which a licence may be in effect is the following:

  • (a) five years, if the licence authorizes controlled activities in respect of

    • (i) a human pathogen that falls into Risk Group 2,

    • (ii) a prion that falls into Risk Group 3, or

    • (iii) a toxin that is not prescribed under section 10;

  • (b) three years, if the licence authorizes controlled activities in respect of a human pathogen that falls into Risk Group 3 — other than a prion — or a toxin that is prescribed under section 10; or

  • (c) one year, if the licence authorizes controlled activities in respect of a human pathogen that falls into Risk Group 4.

• Marginal note:Renewal

  (3) The Minister may renew a licence on application of the licence holder, for further periods set out in subsection (2).