Entries by admin

Drug Establishment License Review

If you are a Canadian facility working with pharmaceutical products intended for the Canadian market, chances are you will require a drug establishment license (DEL) for your building. According to Part C, Division 2 of Health Canada’s Food and Drug Regulations, you are not permitted to fabricate, package/label, distribute, import, test or wholesale a drug […]

Health Canada’s Proposed Labelling Standard for Docusate Products

Health Canada has published a new label standard for docusate calcium and docusate sodium over-the-counter products. This label standard has been developed in association with the Australian authorities (TGA) in an effort to increase regulatory harmonization and alignment between the two regulators. The proposed Non-prescription Oral Stool Softener Laxatives Labelling Standard describes the requirements necessary […]

New Health Canada Labelling Standard for Oral Dextromethorphan

A new label standard for oral dextromethorphan has been posted for consultation on Health Canada’s website. This label standard has been developed in association with the Australian authorities (TGA) in an effort to increase regulatory harmonization and alignment between the two regulators. The proposed Non-prescription Oral Adult Antitussive Cough and Cold Labelling Standard describes the […]