Eurofins Experchem helps global pharma companies enter the Canadian marketplace

Elfi Daniel-Ivad, Regulatory Affairs Manager, Eurofins Experchem Laboratories, elfidaniel-ivad@experchemlab.com

In Canada, medical device and drug regulations are similar to those in other countries, but have their own very specific requirements. Classification of a product in Canada might differ from the US or Europe. For example, sunscreen products are classified as drugs in Canada and require a licence, like other drugs, but are cosmetics in Europe. Also, certain creams and liquids regulated as medical devices in Europe or the US are in many cases regulated as drugs or Natural Health Products (NHPs) in Canada.

Regulations affecting dietary supplements or NHPs differ greatly in Canada compared to other countries. In the US, the Food and Drug Administration (FDA) regulates most dietary supplements as foods, which are not evaluated for safety or efficacy prior to release in US markets. In Canada, however, dietary supplements such as botanical formulations, vitamins, minerals, amino acids, enzymes and homeopathies are regulated as NHPs following guidelines similar to drugs.

When a product is regulated as a NHP, the manufacturer must demonstrate to Canadian authorities that the product is safe and effective before a licence is issued and the product can be marketed. A site licence is required to manufacture, label and/or import a NHP in Canada. To receive a site licence, the company must demonstrate compliance with Good Manufacturing Practices (GMPs).

If a company’s products are already marketed in the USA, Europe or other countries, now could be a good time to look at entering the Canadian marketplace and expanding global reach. Eurofins keeps manufacturers and distributors connected globally, and now the company is pleased to offer regulatory support services to get your product on the shelf in Canada.

Experchem Laboratories, is located in Toronto, Ontario, Canada and was recently acquired by Eurofins. The company has a thriving regulatory affairs department that helps Eurofins clients enter the Canadian market place.

For more information, visit the website: www.experchemlab.com