Canada’s New Labeling Requirements Takes Effect June 13
Drugmakers face new labeling requirements in Canada this month aimed at ensuring that the labeling is clear and easily understood.
Beginning June 13, labels on prescription drugs must be prominently displayed and expressed in plain language. The requirement takes effect June 13, 2017, for nonprescription drugs.
Also starting this month, labels for both prescription and nonprescription drugs must display contact information, and new drugs must undergo a brand name assessment to show that they won’t be confused with other products due to similar names.
Health Canada released guidance last week to help manufacturers comply with the new requirements, which stem from a July 2014 regulation. The agency expects labels and packages will be updated over time.
Read the guideline at www.fdanews.com/06-15-CanadaGuide.pdf. — Jonathon Shacat