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Regulatory Compliance Solutions for Homeopathic Medicines in Canada

Get comprehensive regulatory compliance solutions for Homeopathic Drug Registration in Canada and keep your company compliant, competitive, and profitable. We help startups and small businesses with DIN-HM registration, label compliance, and package compliance. Get the knowledge and assistance you need to complete all regulatory compliance requirements and get your DIN-HM registration.
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What is a DIN-HM?

In Canada, homeopathic medicines must obtain a Homeopathic Medicine Number from Health Canada. DIN-HM in Canada.

The DIN-HM number identifies the product as a homeopathic medicine and is mandatory to include on the product labeling in order to sell your product in Canada. 

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“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

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I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

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Homeopathic Medicine Regulatory Compliance in Canada

Homeopathic medicines are regulated in Canada in the same way that Natural Health Products (NHP) are. In the event that a product is categorized as a drug under the Food and Drugs Act and is marketed without a DIN, it does not comply with Health Canada requirements. Having a DIN-HM in Canada informs patients that the homeopathic medicine has been made in a way that ensures the product’s quality or if the label is comprehensive and correct.

Homeopathic Medicines Criteria

In Canada, the Medicinal ingredient must be found in the homeopathic monograph and one of the homeopathic pharmacopoeias such as the Homeopathic Pharmacopeia of the United States (HPUS), European Pharmacopeia (Ph. Eur) among others.

Canadian Labelling Laws

Homeopathic medicine labels must be bilingual (i.e. both in English and in French) because these languages are considered official in Canada.

Homeopathic Drug Compliance Solutions in Canada

Our Canadian homeopathic compliance experts provide turnkey solutions to meet regulatory compliance. 

DIN-HM Registration

We'll help you in licensing for non-specific health claim based DIN-HM (class 1 NHP) and licensing for specific health claims (class 3 NHP). This includes preparing the necessary documentation for submission.

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DIN-HM Package Compliance and French Translation

Worried about DIN-HM Package Compliance and French Translation? Our experts will help you meet packaging compliance by making homeopathic medicine labels bilingual (English and French) and meeting Canadian labelling laws.

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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