Changes to the Non-prescription Drug Monograph Attestation Process

by dsaadmin | Announcement, Drugs

All non-prescription Category IV Monograph product (DINF) applications must include the new monograph attestation form. Due to unfavorable results of the monograph attestation pilot, Health Canada has put in place processes to ensure that all DINF applications comply...

Reminder to Generic Drug Manufacturers

by dsaadmin | Drugs

Market authorization holders (MAH) of generic drug products regulated under Division 8 of the Food and Drug Regulations are required to file submissions to update their labelling to ensure consistency with that of the Canadian Reference Products (CRP) labeling. On a...

Change to Ibuprofen listing on the Prescription Drug List

by dsaadmin | Drugs

Health Canada has announced that certain uses of Ibuprofen will be changed to nonprescription status by amending the Prescription Drug List (PDL). This change only impacts Ibuporfen for human use; the current Veterinary listing will remain the same. The effective date...

Updates to DEL Applications & GMP Evidence Requirements for APIs

by dsaadmin | Announcement, Drugs

The Active Pharmaceutical Ingredient (API) regulations came into force on November 8, 2013. After a three year transition, November 8, 2016 will mark the full implementation of the Regulations. Health Canada has posted several updates on changes that have been made to...

Changes to Acetaminophen Labelling Standard

by dsaadmin | Drugs

Health Canada is proposing changes to the Acetaminophen Labelling Standard to minimize the risk of liver damage and improve acetaminophen safety. The last update to the Labelling Standard was in 2009 when stronger warnings were adding to non-prescription products to...

Implementation of Advance Notice of Importation for Cosmetics and Drugs

by dsaadmin | Cosmetics, Drugs

The importation for sale of non-compliant cosmetics and drugs, including Natural Health Products is prohibited as per the Cosmetic Regulations and Food and Drug Regulations. However, the Regulations do allow for the importation of non-compliant cosmetics and drugs...