Notice to Stakeholders - Establishment Licence Application deadline - February 8, 2014

New Regulatory Requirements

This is to remind regulated parties that the transition period that was established for regulated parties to comply with the new establishment licence (EL) requirements with respect to active pharmaceutical ingredients (API) has expired. Health Canada amended the Food and Drug Regulations to extend the requirements of Division 1A and Division 2 to APIs used in drugs for human use. The regulatory amendments came into force on November 8, 2013. The department provided a nine-month transition period in order to allow regulated parties time to make necessary adjustments to business practices to come into compliance with Good Manufacturing Practice (GMP) requirements. This transition period was communicated to stakeholders several times. For additional information please refer to the Notice to Stakeholders - Amended Food and Drugs Regulations for Active Ingredients - Coming into force on November 8, 2013.

Establishment Licensing Requirements

Under the Food and Drugs Act, regulated parties have the primary responsibility to produce safe products and are expected to take full responsibility for understanding and complying with all applicable legislative and regulatory requirements. The new EL requirements with respect to APIs affect the following four categories of regulated parties in Canada:

  • API Fabricators, Packagers/Labellers, Testers, Importers and Dosage Form Fabricators that import APIs for use in manufacturing their own products;
  • Dosage Form Importers;
  • Distributors and Wholesalers; and
  • Establishments that began to conduct licensable activities related to APIs starting on or after November 8, 2013.

All establishments in Canada conducting licensable activities with respect to APIs were required to submit an Establishment Licence application form (FRM-0033) respecting the domestic and/or foreign sites in which APIs activities occur before February 08, 2014 in order to be compliant with the requirements and to continue performing their activities. Health Canada works closely with Canada Border Services Agency (CBSA) to make sure that imported health products meet the regulatory requirements prior to entering Canada. Conducting regulated activities without an EL may be subject to compliance and enforcement action.

To date, Health Canada has received more than 500 EL applications in relation to API establishments. Establishments that have submitted applications before the deadline are permitted to continue to conduct activities set out in the EL application form without an establishment licence. These applications will be risk-ranked and prioritized for inspections based on factors such as complexity of the activities conducted and oversight by other regulatory bodies.

Compliance and Enforcement

Making information available to regulated parties and encouraging compliance through education is an important element of Health Canada's compliance and enforcement activities. As such, the department has adopted a phased approach to compliance and enforcement with respect to APIs. As a first step, Health Canada will focus on encouraging compliance through education and other compliance promotion activities in order to facilitate capacity building. For example, Questions and Answers related to Good Manufacturing Practices for active pharmaceutical ingredients have been created to provide additional guidance regarding inspections and GMPs specific to APIs. This Q&A list will be updated by the department on a regular basis. During this initial phase, emphasis will also be placed on managing risk at borders to protect health and safety and increase awareness of the new regulatory requirements with respect to APIs. Between April 1, 2014 and August 31, 2014, importers whose shipments of API are referred to Health Canada by CBSA and are found to be in non-compliance will be notified to apply for an EL immediately. Such importers will also be informed that failure to apply for an EL will result in the refusal of any future shipments of APIs referred to Health Canada by CBSA. After, August 31, 2014, the focus will shift to encouraging compliance through a series of escalating actions that depend on the seriousness of the violation. If Health Canada becomes aware that a regulated party is conducting an API activity without having submitted an application, it will apply the Act and Regulations including action on products sought to be imported.

Compliance and enforcement activities are a key element of safeguarding the health products to which Canadians have access. The primary objective of Health Canada's compliance and enforcement approach is to manage the risks to Canadians using the most appropriate level of intervention. Making information available to regulated parties and encouraging compliance through education is an important element of the department's compliance and enforcement activities. However, if at any time a risk to the health and safety of Canadians is identified Health Canada will take immediate action. The Inspectorate's Compliance and Enforcement Policy (POL-0001) is the foundation document which describes how it delivers its national compliance and enforcement program.

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