Entries by admin

Post Approval Changes for Drugs in Canada

If you’ve received a Drug Identification Number (DIN) or Notice of Compliance (NOC) for selling your drug product in Canada, then that is definitely a cause for celebration. Now it’s smooth sailing until such time as you want to make a change to your drug product. There are two major types of changes you may […]

Workout Supplements – 10 Days to Licensing

It’s no great surprise to anyone that dietary supplement use has been on the rise over the past decade. More and more of us are interested in getting healthy and getting fit, and these products certainly have potential benefits. The workout supplement category has undergone exponential grown in terms of products offered on line and on […]

Producing Medical Marijuana in Canada

Canada’s unique marijuana regulations have been in place since 2013, for the purpose of maintaining strict control over the production and sale of marijuana for medical purposes. These regulations, known as the Marihuana for Medical Purposes Regulations (MMPR), have been the subject of countless news stories worldwide, attracting attention from a broad spectrum of interested […]

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 […]