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Important Health Canada Reminders: Drug Establishment Licence, Drug Shortages, Clinical trials

September 26, 2018

In light of the potential impacts of Hurricane Florence on North and South Carolina, Health Canada is reminding you of certain obligations to notify or report to Health Canada.

1.  Drug Establishment Licence

Health Canada would like to remind you of your responsibilities under C.01A.013 (b) of the Food and Drug Regulations (Regulations):

Notification

C.01A.013 Every person who holds an establishment licence shall notify the Minister in writing within 15 days after

(b) an event occurs that results in their being in contravention of any of the applicable requirements of Divisions 2 to 4, where it may affect the quality, safety or efficacy of a drug fabricated, packaged/labelled, tested as required under Division 2 or stored by them.

Notifications, pursuant to C.01A.013 (b) of the Regulations are to be sent to hc.el.applications-le.sc@canada.ca using the subject “C.01A.13 Notification”. The notification should include a description of the contravention, and a description of the impact the contravention may have on quality, safety and/or efficacy. If available at the time of notification, disclose any action that has been taken or is planned to address the contravention and mitigate the health risk the drug may pose to the consumer.

2.  Expedited Reviews of Drug Establishment Licences

In the circumstances where your foreign building(s) have been affected by events impacting the supply chain of life-saving medicines, Health Canada will consider expediting the addition of new foreign buildings to DELs if it meets one of the following scenarios:

1) When a product is medically necessary.

A medically-necessary drug is defined as a market-authorized drug in Canada which is used to prevent, treat or diagnose a serious or life-threatening disease or medical condition, for which there is no available alternative. Patient inconvenience alone is an insufficient reason to classify a drug as medically necessary. If there are other market-authorized drugs, please provide detailed market data demonstrating that these products are not available. If your product qualifies as medically necessary, please complete the attached template (FRM-0378) and submit it back to the Drug Establishment Licensing Unit at hc.el.applications-le.sc@canada.ca. Use “Request to EXPEDITE: DEL# xxxxxxx; Company name, Add foreign building” as your email subject line. Additionally, please ensure that the application number is provided, if the application was previously submitted to us.

2) When the Therapeutic Products Directorate (TPD)/Biologics and Genetic Therapies Directorate (BGTD) has accepted the application for priority review.

If TPD/BGTD has accepted your application as a priority review, please provide a copy of their acceptance letter indicating this and submit it back to the Drug Establishment Licensing Unit. Use “Request to EXPEDITE: DEL# xxxxxxx; Company name, Add foreign building” as your email subject line. Additionally, please ensure that the application number is provided, if the application was previously submitted to us.

Once you have submitted your completed form, we will assess your request and make a decision.

3.  Requirement to Report Drug Shortages

As of March 14, 2017, sections C.01.014.8 to C.01.014.12 of the Food and Drug Regulations came into force requiring the mandatory reporting of drug shortages and discontinuations through a third-party website (http://drugshortagescanada.ca/). Refer to the guidance document Guide to Reporting Drug Shortages and Discontinuations (https://www.drugshortagescanada.ca/blog/11) for more information and assistance on how to comply with the Regulations.

The Regulations make it mandatory for drug authorization holders to report drug shortages and discontinuations of sale:

  • no less than six months in advance if it is likely to begin in more than six months; or;
  • within five days of becoming aware of the drug shortage or discontinuation of sale if it will begin within six months; and;

The Regulations also make it mandatory to update any posted information on the website within two days of becoming aware of the change.

4.    Clinical trials

As per sections C.05.008 and C.05.007 of the Food and Drug Regulations, sponsors of clinical trials are reminded of their obligations to file a clinical trial application amendment (CTA-A) or notification (CTA-N) to applications previously authorized by Health Canada, when changes that may affect the quality or safety of the clinical trial drug supplies are proposed.  For consideration, if a sponsor of an already approved clinical trial is importing clinical trial drug supplies from North Carolina or South Carolina, and changes to the chemistry and manufacturing information become necessary, a CTA-A or CTA-N may be needed, depending on circumstances.  Sponsors may consult the Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications for some examples of situations that warrant the filing of Quality CTA-A or CTA-N (here: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/clinical-trial-sponsors-applications.html#a242). 

As per section C.05.010, sponsors are responsible for ensuring that clinical trials are conducted in accordance with good clinical practices, and that systems and procedures assuring the quality of every aspect of the clinical trial are implemented.

It is Health Canada’s expectation that regulated parties take the steps necessary to ensure that they are in compliance with the Food and Drugs Act and Regulations