Draft guidance on terms and conditions for human and veterinary drugs: Compliance and enforcement
Market authorization holder does not comply with terms and conditions
All terms and conditions (T&Cs) are enforceable under section 21.7 of the Food and Drugs Act (FDA). MAHs may be held criminally liable for not fulfilling or complying with T&Cs, including failing to submit trials and studies as per their deadlines outlined in the T&Cs letter.
Health Canada may also take compliance and enforcement actions as outlined within the policy:
- Compliance and enforcement policy (POL-0001)
We will apply a risk-based approach when taking regulatory actions related to information generated by the T&Cs, indicating that the:
- drug poses a risk to people in Canada
- veterinary drug poses a risk to animal health or
- predicted efficacy or quality of the drug has changed
Regulatory actions may result in:
- stop-sale
- ordering label changes
- ordering additional studies
- suspending a notice of compliance (NOC) or
- cancelling a drug identification number (DIN)
For subsequent-entry drugs, sometimes the MAH of a CRP or CRBP fails to fulfill their T&Cs or discontinues their DIN, and the CRP or CRBP or any indications of these products are then withdrawn. In such cases, further regulatory action with the MAH of the subsequent-entry drug may be required. For example, in cases where the MAH of the subsequent-entry drug wishes to continue marketing the drug, they may be required to provide evidence to support continued approval of the subsequent-entry drug. We will decide whether that evidence is sufficient to support continued approval.