Please find below a letter outlining revised timelines to complete the Annexes in connection to Health Canada’s letter of April 14, 2021, following up on the completion of nitrosamine risk assessments. Also linked below are answers to new questions to help guide completion of the Annexes.
Please note that this communication is intended for Market Authorization Holders (MAHs) of human prescription and non-prescription pharmaceutical products with a Drug Identification Number (DIN) that contain chemically-synthesized active pharmaceutical ingredients (APIs). It is not intended for MAHs of natural health products.
