Preparation
Gather all necessary safety, efficacy, and quality data for the active ingredient. Ensure the data complies with NHPD requirements.
An NHP-MF (Master File) is designed to enable suppliers of medicinal ingredients or raw materials to provide proprietary information directly to the Natural Health Products Directorate (NHPD) without disclosing it to the applicant. This mechanism applies to medicinal ingredients, non-medicinal ingredients, packaging materials, and safety and efficacy evidence data in support of Product License Applications or Clinical Trial Applications.
Cross-references can be made to NHP-MFs by multiple manufacturers, provided an authorization letter from the Master File originator (holder) is submitted to the NHPD. Maintaining an NHP Master File streamlines the approval process for new products, ensuring timely market access and sustained competitiveness.
An NHP-MF is typically required in the following scenarios:
When a manufacturer introduces a new medicinal ingredient or raw material into the market, which has no previous history of use in natural health products, an NHP-MF must be submitted. This is to ensure that Health Canada can thoroughly assess the safety and quality of the new ingredient.
When the manufacturing details, technical specifications, or processes involved in the production of an ingredient are proprietary, an NHP-MF is required. This allows the manufacturer to protect their proprietary information while still providing necessary details to Health Canada.
If a Product License Application (PLA) or a Clinical Trial Application (CTA) for a natural health product includes ingredients that are covered under an NHP-MF, the master file must be submitted or cross-referenced. This helps to streamline the approval process by providing comprehensive and pre-reviewed data.
An NHP-MF may also be required for non-medicinal ingredients, packaging materials, and safety and efficacy evidence data that are integral to the natural health product’s overall formulation and presentation.
To register a Master File with the NHPD of Health Canada, follow these steps:
Gather all necessary safety, efficacy, and quality data for the active ingredient. Ensure the data complies with NHPD requirements.
Prepare a comprehensive submission package including the data and relevant forms specified by the NHPD.
Complete and submit the Master File application form along with the submission package to the NHPD.
The NHPD will assign a submission number to your Master File and review its contents. Note that the initial review typically occurs when the Master File is referenced in a PLA.
Once reviewed and accepted, the Master File will be registered with the NHPD. It will then be available for reference in future PLAs to support the registration of finished natural health products.
Ensure the Master File is kept up to date with any new relevant data or changes as required by the NHPD.
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An NHP Master File (NHP-MF) serves as a confidential repository of safety, efficacy, and quality data for ingredients used in natural health products. It allows suppliers to share proprietary information directly with Health Canada while keeping it secure from applicants. This ensures compliance with Canadian regulations while maintaining the confidentiality of your data.
An NHP Master File provides Health Canada with detailed data on ingredients, manufacturing processes, and safety evaluations. This includes evidence like toxicology reports and clinical studies, which align with food safety and quality assurance certification standards. These details ensure the product’s quality and safety meet regulatory requirements.
While both involve rigorous safety and quality evaluations, an NHP Master File focuses on ingredients for natural health products, including medicinal and non-medicinal components. In contrast, a food additive submission evaluates substances used to enhance food products. Each process has distinct documentation and approval requirements tailored to its respective category.
Yes, an NHP Master File can be referenced across multiple Product License Applications, provided the file owner authorizes its use. Including a letter of certification of GRAS ingredients strengthens applications by demonstrating prior evaluations of ingredient safety and quality, further simplifying regulatory compliance.
Keeping an NHP Master File up to date is critical for long-term compliance. Challenges may include gathering new safety data for ingredient changes, adapting to evolving Health Canada regulations, and managing cross-references for multiple applications. GRAS Experts offer ongoing support to ensure your file remains accurate and compliant.
The timeline for completing an NHP Master File submission varies depending on the complexity of the ingredient and the quality of the data provided. Typically, preparing the submission can take several months, including gathering safety data and drafting documentation. Once submitted, Health Canada’s review process can take an additional 6 to 12 months. Partnering with GRAS Experts ensures your submission is accurate and complete, helping to avoid delays and streamline approval.
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