The Active Pharmaceutical Ingredient (API) regulations came into force on November 8, 2013. After a three year transition, November 8, 2016 will mark the full implementation of the Regulations.
Health Canada has posted several updates on changes that have been made to the way API submissions are processed and changes to the GMP evidence requirements of foreign API buildings.
It is Health Canada’s expectation to have on file a consolidated up-to-date Table A at all times. Effective immediately API submissions will be screening for completeness. Complete applications will be screened within 20 business days. Once an application is screened successfully an “Acknowledgement of Acceptance” will be issued.
Further, importers are not allowed to import APIs manufactured at or Finished Dosage Forms manufactured from APIs from any foreign building not listed on the most recently submitted Table A until they’ve received the “Acknowledgement of Acceptance” for the addition of the new sites.
Health Canada will also begin to issue DEL API Foreign Building Annexes.
As of November 8, 2016 importers will be expected to have satisfactory GMP compliance evidence on file for all foreign API buildings listed on Table A.