proposed amendment to the food and drug regulations 1470 non-medicinal ingredients 13 pages available in english and french applications for drugs regulated solely under part c division 1 of the food and drug regulations those drugs that have been sold in canada for a sufficient time and in sufficient quantity to establish safety and effectiveness i.e. the majority of non-prescription drugs are not required to include information on the non-medicinal ingredients nmis present in the formulation of the drug. as a result health canada generally does not receive a complete quantitative list of nmis for division 1 drugs unless voluntarily provided by the manufacturer of the drug. therefore if a health risk to canadians is posed by a specific nmi health canada is limited in its capacity to develo risk management strategies since it would be challenging to identify the division 1 drugs on the market which contain the ingredient in question. the proposed regulatory amendment would apply to prescription and non-prescription drugs intended for human and animal use that are solely regulated under part c division 1 of the food and drug regulations. the amendment would not affect drugs that are regulated under division 8 of the food and drug regulations i.e. new drugs as they are already subject to similar requirements. the proposed changes to the food and drug regulations would introduce the following requirements 1 the submission of a full quantitative list of all the nmis present in a drug as part of a drug identification number din application. 2 that sponsors of currently marketed division 1 drugs submit their full product formulations to health canada. 3 that subsequent changes to the formulation of a drug holding a din and present on the market be submitted to health canada within 30 days of the change. the proposed regulatory amendment would be complementary to project 743 addressing nmi labelling recently published in the canada gazette part ii g tbt n can 271 add.1 which requires sponsors to list the nmis on the outer labels of drugs with some exceptions. those regulations which will come into force on may 13 2012 will provide consumers with label information about nmis which will assist them in avoiding allergens and agents for which they have a history of adverse reactions. the current proposal would provide health canada with nmi information that may enhance risk management activities should issues arise post-market.