Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and
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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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https://youtu.be/iojmXU4ZSx4 What is Natural Health Products Ingredients Database (NHPID)? The Natural Health Products Ingredients Database (NHPID) is an electronic tool
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1. What is the NHP Licensing Process/what is needed for it? This process involves the submission of a product license
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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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Do you want to learn about the food regulations for food sales in North America? This could include food facility
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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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This blog unpacks the distinctions between NHPs, Health Canada & FDA-approved drugs, and cosmetic product regulations that define these products.
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Food Labelling 101 Food labelling is an important aspect for consumers across the globe. Food labels are used as reliable
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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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What is a Cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
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How Medical Devices are Classified in Canada Regulatory Classification Basics for your Medical Device: There are certain rules that apply
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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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Introduction The purpose of this guidance document is to give stakeholders directions on how to be compliant with Natural Health
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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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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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As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
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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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Background on NAC N-acetyl-L-cysteine (NAC supplement) has been approved by the FDA to treat liver side effects from an overdose
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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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How to Minimize the Risk of Border Detention Shipping Consumer Packaged Goods As an importer of consumer packaged goods, unanticipated
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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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Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is
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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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Identifying the correct application type has become increasingly more crucial for Natural Health Product (NHP) applications. Incorrect classification can result
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Health Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is
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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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In light of the current COVID-19 pandemic, Health Canada is taking action to increase supplies of disinfectants and hand sanitizers.
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What is a HACCP Plan? Food safety is always evolving and becoming more complex, as companies require constant updating with
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The purpose of a Hazard Analysis Critical Control Points (HACCP) plan is to identify and control any hazards that may
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In light of the recent Coronavirus pandemic, the demand for antimicrobial products such as disinfectants and hand sanitizers are skyrocketing. The
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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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When it comes to topical essential oils, determining the correct regulatory pathway to ensure full compliance typically depends on how
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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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The Canna Regulations were officially published in Canada Gazette Part II on July 11, 2018. The regulations outline several different
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Summertime has finally arrived and with it comes hot temperature and intense ultraviolet rays. Exposure to ultraviolet light is known
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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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You might have heard a little something in the news recently about the legalization of Canna coming to Canada. Needless
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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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Hydrolyzed collagen and gelatin are animal-based proteins that have recently gained popularity within the food and supplement industry. Gelatin and
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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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In the winter and spring of 2017 Health Canada inspectors visited 23 companies. The program was called a compliance monitoring
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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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Often the dietary supplement landscape in the United States has been referred to as the “Wild, Wild West” with many
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