NMI Labelling Disclosure for Drug Products
Until now, the drug framework in Canada has been one of the few regulatory frameworks which does not require full-ingredient disclosure on product labels. Health Canada has made several attempts to bring requirements for non-medicinal ingredient labelling into force but has never been successful, until now.
Regulatory Requirement for Non-Medicinal Ingredient (NMI) Labelling are expected to take effect May 12, 2012.
Health Canada has released several Informational guidance documents on their website this week regarding the upcoming Non-Medicinal Ingredient (NMI)listing requirements. These requirements will apply to most drug products intended for human use. Prescription drugs, non-prescription drugs only administered under the supervision of a health care practitioner, low level disinfectants (hard surface) and Veterinary Drugs will be exempt from these requirements.
Manufacturers/Sponsors will be required to submit a letter of attestation to Health Canada to certify that their products meet the NMI regulations and their expected date of compliance. Health Canad has already included notifications regarding these requirements in the Annual Drug Notifications which are currently being sent out to Submission Sponsors.
