Getting your site license application approved for natural health products just got a little bit easier in Canada. After much anticipation the Natural and Non-Prescription Health Products Directorate (NNHPD) published their new Site License Guidance Document, Version 3.0 in December of 2015. Highlights of the new document include: Explanation of the different types of deficiencies […]
Good Manufacturing Practices (GMP) is a term understood and well recognized worldwide for the control and management of manufacturing and testing of pharmaceutical products. In Canada the GMP requirements also apply to natural health products (dietary supplements). Adopting GMP can help avoid: adulteration or contaminated products, labelling errors such as the incorrect label or missing risk information, distribution […]
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 […]
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 […]
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 […]
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 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 […]
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 […]
Regulatory Compliance Just Got Easier
