Site Licensing & GMP Compliance
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Site Licensing & GMP Compliance — Canada
Under Canada’s Natural Health Products Regulations (NHPR), companies that manufacture, package, label, or import Natural Health Products (NHPs) must hold a valid Site Licence and comply with Good Manufacturing Practices (GMP).
This requirement applies not only to supplements, vitamins, and herbal products, but also to many topical Natural Health Products, including:
- Mineral sunscreens
- Medicated skincare products for eczema, acne, and dandruff
- Aromatherapy products with therapeutic claims
- Certain topical wellness and therapeutic formulations regulated as NHPs rather than cosmetics
GNHP Consulting provides structured regulatory and quality assurance support for companies requiring Site Licensing, GMP compliance systems, quality documentation, importer compliance, and operational readiness aligned with Health Canada expectations.
A Site Licence authorizes a company to conduct regulated activities involving Natural Health Products in Canada, including:
- Manufacturing
- Packaging
- Labelling
- Importation
Health Canada requires Site Licence holders to demonstrate compliance with Good Manufacturing Practices (GMP), including quality systems, documentation controls, sanitation procedures, recall systems, personnel training, specifications, and quality assurance oversight.
Companies operating without the required Site Licence may face regulatory action, marketplace restrictions, or inability to legally distribute products in Canada.
Site Licensing requirements apply to:
- Canadian NHP manufacturers
- Importers of Natural Health Products
- Contract manufacturers
- Companies packaging or labelling NHPs
- Businesses importing supplements into Canada
- Companies manufacturing topical NHPs such as mineral sunscreens and medicated skincare products
This includes many businesses that mistakenly assume their products are regulated only as cosmetics. Proper product classification is essential.
Good Manufacturing Practices (GMP) are mandatory for Site Licence holders and are designed to ensure that Natural Health Products are consistently manufactured, packaged, labelled, stored, and distributed according to quality standards.
Health Canada GMP requirements include:
- Product specifications
- Quality assurance systems
- SOPs and documentation controls
- Sanitation programs
- Equipment and premises compliance
- Personnel training
- Stability programs
- Recall procedures
- Record keeping and traceability
Our Site Licensing & GMP Services
We assist companies with:
- New Site Licence applications
- Site Licence amendments
- Site Licence renewal applications
- Importer Site Licence compliance
- Documentation review and submission preparation
We help companies establish and strengthen GMP systems aligned with Health Canada requirements.
Services include:
- SOP development and review
- Quality assurance systems
- Batch record review
- Product specification development
- Deviation and CAPA support
- Recall and complaint procedures
- Documentation and record control systems
Start-up companies often require practical GMP implementation guidance before beginning operations or applying for Site Licensing.
We provide:
- GMP training for founders and operational teams
- Basic quality systems implementation
- Regulatory readiness planning
- Inspection preparation guidance
- Compliance-focused operational structure support
Topical NHP & Therapeutic Skincare Compliance
Many topical wellness products regulated as Natural Health Products require both Product Licensing and Site Licensing compliance.
We support companies manufacturing or importing:
- Mineral sunscreens regulated as NHPs
- Therapeutic aromatherapy products
- Medicated skincare for eczema, acne, or dandruff
- Other topical Natural Health Products requiring NPN authorization
Services include:
- Product classification assessment
- GMP compliance guidance
- Site Licence readiness
- Product specification support
- Label and claims review
Importers of Natural Health Products into Canada must ensure that products are manufactured, packaged, labelled, and tested under compliant conditions.
We support importers with:
- Importer Site Licence applications
- Foreign manufacturer evidence review
- GMP documentation assessment
- Supplier qualification support
- Regulatory compliance readiness for imported products
We also assist companies addressing:
- Health Canada observations
- GMP deficiencies
- Documentation gaps
- Site Licence concerns
- Non-compliant operational systems
- Marketplace compliance issues
Our remediation approach focuses on practical corrective action and long-term compliance sustainability.
We work with:
- Natural Health Product/Supplements manufacturers
- Importers of NHPs/Supplements
- Contract manufacturers of NHPs
- Therapeutic skincare and sunscreen brands
- Start-ups building GMP systems
- International companies entering the Canadian market
Whether you are preparing your first Site Licence application or strengthening an existing quality system, GNHP Consulting provides practical regulatory support tailored to your operation.
Clients choose GNHP Consulting for:
- Practical GMP and Site Licensing expertise
- Support for both operational and regulatory requirements
- Experience with importer and foreign site compliance
- Structured quality assurance systems development
- GMP training for start-ups and growing companies
- Regulatory guidance for topical NHPs and therapeutic skincare products
We help companies build compliant systems that support both regulatory success and long-term operational growth.
Site Licensing and GMP compliance are critical components of manufacturing, importing, packaging, and distributing Natural Health Products in Canada.
GNHP Consulting provides strategic regulatory and quality assurance support to help your business move forward with confidence.
Begin Your Compliance Journey With Us Today
How we can help you
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Certifications
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