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RESOURCES / REGULATORY GUIDES

Regulatory guides, market by market.

Category rules, submission expectations and certification requirements for the markets our clients enter most often.

Canada

Health Canada NPN

Product licensing, monograph use and evidence expectations for natural health products in Canada.

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Canada

Health Canada NPN

Product licensing, monograph use and evidence expectations for natural health products in Canada.

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United States

FDA Regulatory

Supplement, food and OTC boundaries, monograph eligibility and labelling exposure in the United States.

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United States

FDA Regulatory

Supplement, food and OTC boundaries, monograph eligibility and labelling exposure in the United States.

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European Union

EU & EFSA

Novel food status, authorised claims and member-state notification routes across the European Union.

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European Union

EU & EFSA

Novel food status, authorised claims and member-state notification routes across the European Union.

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Australia

TGA Australia

Listed and assessed medicine pathways, permitted indications and ingredient restrictions.

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Australia

TGA Australia

Listed and assessed medicine pathways, permitted indications and ingredient restrictions.

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China

SAMR registration routes, Blue Hat filing requirements and ingredient list constraints for the Chinese market.

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China

SAMR registration routes, Blue Hat filing requirements and ingredient list constraints for the Chinese market.

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Japan

Food with Function Claims, FOSHU pathways and the evidence expectations behind each Japanese route.

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India

FSSAI nutraceutical schedules, permitted ingredient lists and licensing steps for the Indian market.

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Certification

NSF Certification

What certification covers, what it does not, and when it is worth the audit and testing burden.

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Certification

NSF Certification

What certification covers, what it does not, and when it is worth the audit and testing burden.

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