Navigating the medical device regulations set by Health Canada can be a complicated task, but knowing the specific classification
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The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device Licence
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The Canadian Food Inspection Agency (CFIA) protects Canadians’ health and safety by ensuring food that reaches customers is safe, nutritious, and
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U.S.A RRA FDA Draft Guidance: In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation
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Top Canada Cosmetic Regulations Cosmetic Notification Form (CNF) Canada is one of the most popular tourist destinations in the
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Background on FDA NAC Warning Letters: Navigating the FDA’s NAC system can be overwhelming. Understanding FDA warning letters is key
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Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is
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The Canadian government has a set of regulations in place for natural health products (NHPs). These regulations help to
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The following are seven steps for businesses that want to get their FSVP certification. Follow our FSVP checklist to ensure timely results.
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The Medical Device License is a legal document that is required for the manufacture, sale, and distribution of medical
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Many drug industries are working in every country. To sell any OTC drug in Canada is not possible without
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The FSVP Plan is a requirement for many companies to be FSMA compliant. It is the responsibility of the company
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Nowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems.
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Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory
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https://youtu.be/XRZ87ifRki0 Since the publishing of the Safe Foods for Canadians Regulations in 2017, there is now a requirement for a
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If you’re selling natural health products in Canada, understanding NHPID and NPN is essential. These tools from Health Canada determine whether your ingredients are acceptable and whether your product is eligible to be sold legally.
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https://youtu.be/O7GbA-Awo0g 1. What is the NHP Licensing Process/what is needed for it? This process involves the submission of a product
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In this blog, we’ll focus on answering your questions about the SFCR License and Preventive Control Plans, including why they
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Overview Manufacturers of prescription and non-prescription drugs are required to obtain a Drug Identification Number (DIN) before the drug product
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https://youtu.be/veCBMkYUWEU Market Analysis and Overview of CPG Market: Will CBD Products be considered an NHP? The consumer packaged goods (CPG)
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Save time & money by learning food regulations for food sales in North America including food facility registration, TMAL, FSVP, and more.
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Who needs a Foreign Site Reference Number (FSRN)? For Natural Health Products (NHPs) manufactured, packaged, and/or labeled by sites located
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As a license holder for Natural Health Products (NHPs), it is your responsibility to be aware of and educated on
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Learn how to classify your product as a drug, NHP, or cosmetic in Canada. Understand key decision-making criteria, borderline examples, and what regulatory path you need to follow to stay compliant with Health Canada.
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Have you ever looked at a food label and wondered why all that information is there? Labels do more than
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What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
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Introduction: The market for animal and pet products is growing at a rapid pace. With that, there is also a
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What is HACCP? A common question that comes up in regulated industries, such as food manufacturing and processing, is “What
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1. What are over-the-counter drug products (OTC drugs)? Non-prescription drugs also called over-the-counter (OTC drugs), are health products that can
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Introduction Dietary supplements in the USA are very similar to natural health products (NHP regulations) in Canada and many products
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Cosmetic Notification Forms Must be Completed Accurately For Quick and Efficient Processing by Health Canada. Work with QSS Today to File Your Notifications!
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Top 5 Tips to Successfully Secure an NPN Number In order to sell a Natural Health Product (NHP) in Canada
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Natural Health Products have different characterization, identification, quantification, and purity standards that you should know about to ensure the quality
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Regulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines
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What is a claim? A claim is a representation for sale. It can be presented as “a word, a sentence,
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In general, all drug products (including over-the-counters and biologics) must be authorized for sale by Health Canada, before they can be
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All Natural Health Products (NHPs) sold in Canada are subject to the Natural Health Products Regulations (NHPR). Natural Health Products
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Introduction: The Consolidated Appropriations Act, recently passed by the US Congress, incorporates revisions to US cosmetics laws. The Modernization of
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Medicinal Mushrooms in powder, capsule or liquid form can be licensed as Natural Health Product (NHP) in Canada. To sell
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What is a Cosmetic? Cosmetics are a part of just about everyone’s life. Every day, most of us use products
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The classification of Foods and Natural Health Products (NHPs) can be considered difficult, grey, and convoluted. Sometimes even comes down
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The US Environmental Protection Agency (EPA) is saddled with the responsibility to register pesticides in the US. This process is
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What to Expect After Submitting an NPN Application In order to sell a Natural Health Product (NHP) in Canada, you
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Pet Foods and Human Food Labels are designed to look similar yet distinct. There are some similar label requirements and
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The advancement of technology is rapidly progressing, and the evolution can be observed all around us. As cutting-edge technology becomes
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The CBSA has the authority to detain consumer packaged goods at the border. QSS can help ensure there are no delays bringing your goods into Canada!
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Inspection of your food facility will help identify and fix any quality or processing deviations found regarding food safety. Review
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What is Hemp Seed Oil categorized as in Canada? In Canada, Hemp (Canna Sativa) seed oil can be categorized as
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Advertising is something almost all people experience and view daily. Yet, it can be challenging to navigate this space as
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Who Needs an MDSAP Certificate? Anyone looking to manufacture a Class II, III or IV medical device in Canada requires
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In the world of compliance and quality management, audits are a fact of life. Auditing verifies adherence to standards or
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Animal Supplements in the USA – What You Need to Know How are animal supplements regulated in the USA? Dietary
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The product label is something we all look at in our daily lives, but not everyone is well equipped with
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How to Sell Dietary Supplements or NHPs on Amazon or Other Online Platforms in Canada? What is an NHP? In
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COVID-19 and Hard Surface Disinfectants – What You Need to Know In Canada, chemical products that are used to clean,
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Natural Health Products (NHPs) are regulated by Health Canada under the authority of the Food and Drugs Act and the Natural
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Conventional Foods vs. Supplemented Foods The easiest way to know the difference between these categories are that Conventional foods are
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Introduction: Identifying the correct application type has become increasingly crucial for Natural Health Product (NHP) applications. Incorrect classification can result
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Health Canada’s notice on interim orders relating to COVID-19 and medical devices acknowledging stakeholders require predictability for regulatory aspects.
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Earlier this summer, Health Canada provided a notice to industry on the regulatory considerations for non-medical masks or face coverings,
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HACCP Plan and the Food Handler’s Certificate are important in today’s food industry. Our experts help you navigate all food safety measures.
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With the need for hand sanitizers significantly increasing for healthcare personnel and individuals during the current COVID-19 pandemic do help
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The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) introduces amendments to the Food and Drugs Act that will improve Health Canada’s ability to
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All marketed drugs and health products have benefits and risks. All health products are carefully evaluated before they are licensed
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All drugs subject to the Food and Drug Regulations are required to gain premarket authorization prior to issuance of a
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When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the
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The label and package are the first points of interaction between a health product and a consumer. Prior to the
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In continuation to the last article on Canadian legislations and requirements regarding the marketing of drugs and medical devices, this
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Health Canada is not only the national regulatory authority for issuing health product marketing authorizations, but it also oversees and
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Under the Food Safety Modernization Act (FSMA), the United States (U.S.) started graduated enforcement of the Foreign Supplier Verification Program
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Natural Health Product Brand Name Guidance Brand names are an important part of your marketing strategy, but as many of
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The Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into
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Learn if your essential oils are NHPs or cosmetics in Canada. Discover the right license and stay compliant with Health Canada.
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The European Food Safety Authority (EFSA) is a world renowned regulator which is known for its high scientific standards when
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Supplemented foods and natural health products (NHPs) can sometimes pose challenges when trying to determine the correct regulatory pathway to
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https://youtu.be/BEsWTYXGqAQ Summertime has finally arrived and with it comes hot temperatures and intense ultraviolet rays. Exposure to ultraviolet light is
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The Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into
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Health Canada implemented the Plain Language Labelling (PLL) initiative to help make the labels for non-prescription health products easier to
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In October 2014, the Natural and Non-prescription Health Products released a policy to manage the overall application review process. It
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Just a little background information first before I talk about the business aspect of capitalizing on your NPN. NPN stands
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On November 21, 2017 the Canadian Minister of Health announced the Proposed Approach to the Regulation of Canna. The public
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BACKGROUND Originally implemented in 1920 after the inception of the Federal department of Health in 1919, the Food and Drugs
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Some companies make the assumption that selling a dietary supplement product in Canada is no different than selling in the
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Health Canada recently announced their initiative to modernize the regulatory framework for health products and foods. This is required due
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