Tough Road Ahead for Drug Establishment Licensing

On August 29th, 2012 Health Canada posted a notice on their website regarding:

  • Renewing Foreign Sites that are Nearing Expiration

  • New: Changes to Calculation of Period of Validity/Expiry for Foreign Site Evidence

In order to maintain a valid foreign site, Drug Establishment License (DEL) holders must submit an application along with full and complete GMP evidence at least 250 days before the expiry of the foreign site. This application may be in the form of an Amendment to update the foreign site evidence or as part of the Annual Review application.

This is a drastic change from previous requirements which allowed companies to submit 90-120 days in advance. To illustrate just how prepared a company has to be, if a foreign site’s evidence expires on July 8, 2013, an application should be received by Health Canada by October 31, 2012, in order to be processed and issued within the 250 day (approx. 8-9 months) service standard.

Failure to submit an application at least 250 days in advance of the expiry of the foreign site or failure to submit full and complete GMP evidence with the application may result in the expiry of the foreign site. This has huge cost implications on the drug industry in Canada. This will increase industry costs and require additional resources since companies will require audits sooner and more frequently to meet the 250 day deadline. The pressure to meet the 250 day standard is very high and missing this deadline will cause a delay in the importation of products, creating a serious headache for companies in Canada.

What to Do:

  • Ensure valid GMP Evidence is readily available for Health Canada 250 Days prior to Establishment License application or renewal.
  • Contact FPR well in advance of this 250 day period to help prepare for timely and successful Establishment Licensing.

If you have any questions about how to prepare for Establishment Licensing or Renewals, please contact us at 905-271-2709.