Revised Timelines for Nitrosamines Risk Assessment

On May 26, 2021, Health Canada extended the timelines for activities related to Nitrosamines Risk Assessment in consideration of the on-going COVID-19 pandemic and challenges associated. To mitigate the risk of presence of nitrosamine impurities, Health Canada has requested that Market Authorization Holders (MAHs) follow a three-step process for assessing and controlling the nitrosamine impurities in all human pharmaceutical products (prescription and non-prescription (over-the-counter)) containing chemically synthesized active pharmaceutical ingredients (APIs). The initial deadline to complete the risk assessment (Step 1) was extended to March 31, 2021. On April 14, 2021, Health Canada issued a follow up letter [...]

2021-07-20T20:44:25+00:00June 1st, 2021|

What you need to know about Health Canada’s Regulatory Amendments for Non-Prescription Drug Products (GUI-0001)

Health Canada's regulatory amendment to the Food and Drugs Regulations Guidance Document GUI-0001 came into effect on July 1st as part of the Canada-United States-Mexico Agreement (CUSMA) and replaces the previous 2018 edition. The new amendments emphasize finished product testing of non-prescription drug products and directly affects importers and distributors and requires reviewing and updating of certain documents and agreements. Non-Prescription Drug Products The new expectations from the regulatory amendments are an effort to streamline and provide flexibility to the importation and distribution of the following lower-risk non-prescription drug products: Personal care use antiseptic skin cleansers Sunscreens Anti-dandruff products [...]

2020-08-06T19:53:51+00:00August 6th, 2020|
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