Improvements to the Application Process for Foreign Buildings on a Drug Establishment License

Health Canada has made significant changes to the application process for foreign buildings that are listed under a company’s Drug Establishment Licence (DEL). This information is important for any importer and/or drug submission sponsor in Canada that imports from a foreign site.

It is essential that in order for a foreign building to be added to a company’s DEL, it has to have compliant Good Manufacturing Practices (GMP) in place. In the past, any foreign building on a company’s DEL Foreign Building Annex had an expiry date that was based on the building’s GMP evidence that they provided to Health Canada. DEL holders had to submit their application containing updated GMP evidence within 250 days before the expiry date to prevent the possibility of their foreign building becoming removed from their Foreign Building Annex.

The application process is now changed and importers do not have to submit their updated GMP evidence 250 days before expiry. As long as the importer submits an application that is complete and contains the updated GMP evidence by the New Evidence Required By (NERBY) date, the foreign building can be classified as GMP compliant and can be listed on the company’s DEL Foreign Building Annex. If the GMP evidence is considered to be incomplete or unacceptable, Health Canada can remove the foreign building from the Foreign Building Annex, therefore not allowing the company to import from that building location. In order to allow the company to import from that building again, the company must re-perform the full application process to add the foreign building back onto their DEL.

The NERBY date will be determined using a risk-based approach but will usually be 4 years from the inspection start date. The NERBY date can also be either shorter or longer than the typical 4 years based on various factors such as the category of the drug and compliance history. However, the exception is that the NERBY date will not be added to the DEL of any Active Pharmaceutical Ingredient (API) buildings on the company’s API Annex. Also, Health Canada is no longer asking companies who are DEL holders to complete a full application and submit it to renew their GMP evidence for a foreign building that is located in a Mutual Recognition Agreement (MRA) country. These are huge changes that are significant improvements for companies holding a DEL.

We hope that this information is helpful to you. If you have any questions, please feel free to contact Focal Point Research. We are industry leading Drug Product Consultants that you can trust to help guide your company in the right direction.

Source: Health Canada Drug GMP Inspection Unit Bulletin from July 21st, 2016