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Regulatory Framework for Licensing Contraceptive Medical Devices in Canada

15

Jul

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Medical Devicesbilingual labelling, Class II devices, Class III devices, clinical evidence, contraceptive medical devices, health canada, ISO 13485, Medical Device Licence, post-market surveillance

Regulatory Framework for Licensing Contraceptive Medical Devices in Canada

The licensing pathway for contraceptive products in Canada can be complex, particularly for manufacturers and importers aiming to introduce new products or expand existing lines. One of the main challenges is the lack of clear, consolidated guidance that explains how different types of contraceptives are regulated under Canadian law. Hormonal…

Health Canada Publishes Updated Natural Health Products Monographs – June 27, 2025 Update

27

Jun

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NHPshealth canada, natural health products, NHP monographs, product compliance, Regulatory Updates

Health Canada Publishes Updated Natural Health Products Monographs – June 27, 2025 Update

On June 27, 2025, Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) will release eight new monographs and revise three existing ones. These updates are part of Health Canada’s continued efforts to maintain regulatory guidance that is accurate, up to date, and reflective of current evidence and product trends. …

May 2025 Health Canada’s Proposed Updates to the Cosmetic Ingredient Hotlist: What You Need to Know

27

May

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Cosmetics2025 updates, CMP, cosmetic compliance, Cosmetic Ingredient Hotlist, cosmetics regulation, health canada, prohibited substances, restricted ingredients

May 2025 Health Canada’s Proposed Updates to the Cosmetic Ingredient Hotlist: What You Need to Know

Health Canada has released a Notice to Stakeholders outlining proposed updates to the Cosmetic Ingredient Hotlist. This notice serves as a heads-up for cosmetics manufacturers, importers, and formulators to review upcoming regulatory considerations and begin preparing for potential product reformulations. Overview: What is the Cosmetic Ingredient Hotlist? The Cosmetic Ingredient…

April 2025 Additions to Health Canada’s Prescription Drug List (PDL): What You Need to Know

20

May

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DINsdrug regulation, efanesoctocog alfa, fecal microbiota, health canada, inavolisib, loncastuximab tesirine, PDL, Prescription Drug List, retifanlimab, rozanolixizumab, sipavibart, tofersen, vaborbactam

April 2025 Additions to Health Canada’s Prescription Drug List (PDL): What You Need to Know

When most people think about prescription drugs, they may not consider the regulatory framework that determines which medicines are available only by prescription. But in Canada, this distinction is critically important and tightly governed by Health Canada through its Prescription Drug List (PDL). In a recent regulatory update published on…

Health Canada NHP Monograph Updates Coming April 25, 2025: What You Need to Know

30

Apr

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NHPsApril 2025 monographs, eleuthero, flaxseed oil, health canada, natural health products, NHP updates, PLA, Product Labelling, pseudoephedrine

Health Canada NHP Monograph Updates Coming April 25, 2025: What You Need to Know

If you're working with Natural Health Products (NHPs) in Canada, it's essential to stay ahead of Health Canada’s regulatory updates. As of April 25, 2025, five updated NHP monographs will be published, and they may impact product licences, labelling, and formulation strategies. Whether you're submitting a new Product Licence Application…

How to Prepare Finished Product Specifications (FPS) for NHPs

28

Apr

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NHPsfinished product specifications, FPS, health canada, natural health products, NHP compliance, NHP licensing, product testing, quality assurance, regulatory standards

How to Prepare Finished Product Specifications (FPS) for NHPs

Finished Product Specifications (FPS) are crucial documents that outline the minimum quality standards an Natural Health Product (NHP) must meet before it can be imported, sold, or distributed in Canada. These specifications are mandated under Health Canada's Natural Health Products Regulations (NHPR), and every NHP must strictly comply with the…

NHP Sampling Regulations for Tradeshows in Canada

23

Apr

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NHPscanadian regulations, consumer safety, health canada, natural health products, NHP compliance, NHP Labelling, NHP sampling, NPN, product distribution, product licensing, tradeshow exhibitors, tradeshow regulations

NHP Sampling Regulations for Tradeshows in Canada

Distributing Natural Health Product (NHP) samples at tradeshows in Canada is subject to clear regulatory requirements designed to protect consumer safety, ensure accurate labelling, and uphold Health Canada’s standards. From proper packaging and compliant promotional claims to valid licensing and record-keeping obligations, all participants are responsible for operating in accordance…

03

Mar

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Food, International TradeCFIA, European Commission, European Food Safety Authority, Food Regulations, health canada, importing foods, Safe Food for Canadians

Importing Food from Europe to Canada: Review of Requirements

As global trade continues to expand, the import of food products from Europe to Canada presents significant opportunities for businesses looking to reach new markets. However, ensuring compliance with both European and Canadian food regulations is crucial for a smooth and successful import process. The European Union (EU) enforces some…

Updates to Regulations for Nicotine Replacement Therapy (NRT) Products Sold as Natural Health Products

30

Jan

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UncategorizedCanadian Market, health canada, Nicotine Replacement Therapy, NRT, Supplementary Rules Respecting Nicotine Replacement Therapies

Updates to Regulations for Nicotine Replacement Therapy (NRT) Products Sold as Natural Health Products

December 2024 Update: Notice of Intent for Transition Period of New NRT Provisions Health Canada has issued a Notice of Intent to extend the transition period for the changes to the labelling and packaging requirements for Nicotine Replacement Therapy (NRT) products. Initially, under the Supplementary Rules Respecting Nicotine Replacement Therapies…

Health Canada’s NNHPD Monograph Revisions: Batch 4 Consultation Period Begins

06

Sep

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UncategorizedCanada Regulatory Compliance, health canada, labelling standards, natural health products, NHP, NNHPD, NNHPD monograph, product formulations, safety and efficacy

Health Canada’s NNHPD Monograph Revisions: Batch 4 Consultation Period Begins

Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) is undertaking a critical initiative to revise existing Natural Health Product (NHP) monographs. These revisions are essential for aligning monographs with new labelling standards, ensuring consistency, and incorporating the latest scientific information. Health Canada’s goal is to improve the quality and…