New GMP regulations for Active Pharmaceutical Ingredients Come Into Force

Posted by on Jun 14, 2013 in Latest News | 0 comments

According to Health Canada, regulations amending the Food and Drug Regulations to extend Good Manufacturing Practices requirements to active pharmaceutical ingredients, together with the Regulatory Impact Analysis Statement (RIAS) for the proposal, have been published in the Canada Gazette, Part II. The new regulations come into force as of November 8, 2013.

Health Canada will update the information on the API page of their website.

This new regulation means that companies importing and wholesaling Active Pharmaceutical Ingredients in Canada will have to obtain Drug Establishment Licenses for the activities that they carry out.