DSA Consultants Blog

Elimination of Schedule F from the Food and Drug Regulations On April 26, 2012 an announcement was made by the Minister of Health that Schedule F of Health Canada’s Food and Drug Regulations will be eliminated.   Schedule F is a listing of drugs which require a prescription from a medical doctor to

Health Product Advertising on Physician Websites Recently, Health Canada wrote to the registrars of the provincial medical regulatory authorities about physicians promoting health products on their Web sites. They have received complaints about this practice (direct-to-consumer advertising of prescr

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

Reconsideration Process through NHPD Many companies are finding that NHPD is increasingly issuing Notices of Refusal (NOR) to shorten their review queue. What happens if you receive a Notice of Refusal?  You have a few options.  You can either accept the refusal, re-file your submission, or you can

Renewal of Medical Device Licenses Health Canada has released a new Guidance document for Industry entitled “Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices” It is effective July 1st, 2011 and replaces the earlier 2005 guidance document. This guidance is to pro

Health Canada has updated the user fees related to the licensing and sale of Drugs and Medical Devices. Initial Health Canada user fees were introduced in 1995 and in 1998 and represented 50% of the cost at that time. Fees have not been increased since their inception and now represent only approxim

NHP Standards of Evidence and New Compliance and Enforcement Policy NHPD is currently undertaking revisions to the guidance document which relates to the Standards of Evidence (SoE) for Non-Traditional Natural Health Product Submissions.  While this occurs, Health Canada is extending the compliance

Health Canada releases Final Guidance on Schedule A / Section 3 to the Food and Drugs Act Schedule A to the Food and Drugs Act (FDA) is a list of diseases, disorders, or abnormal physical states for which there is no known cure.  As such, the Food & Drugs Act (FDA) prohibits the labelling and adver

Assessment of Naturally-Sourced Ingredients found on Schedule F Health Canada has issued an update on the Assessment of Naturally-Sourced Medicinal Ingredients found on Schedule F. Schedule F of the Food and Drug Regulations regulates ingredients that require a prescription for sale. Health Canada i

Risk-based Approach to Site Licensing (RBASL) for NHPs   Health Canada has issued an update of work currently underway to build an enhanced Risk-Based Approach to site-licensing (RBASL) for manufacturers, packagers, labellers and importers of natural health products (NHPs). This new approach is in