
10 tips to Prepare for the Safe Food License Application Process
Introduction: There are many reasons that you might want to get licensed as a food processor or retail operator. You
... Read moreIntroduction: There are many reasons that you might want to get licensed as a food processor or retail operator. You
... Read moreSubmitting a 510 K Premarket Notification is an essential step in the process of getting medical devices approved by
... Read moreThe purpose of a Hazard Analysis Critical Control Points (HACCP) plan is to identify and control any hazards that may
... Read moreIntroduction Like most food businesses, you probably spend a lot of time thinking about what’s in your food and how
... Read moreIntroduction: The FDA offers an online dietary supplement labeling guide that provides labeling requirements for supplement manufacturers. The guide covers
... Read moreThe Global Food Safety Initiative: What You Need to Know: The Global Food Safety Initiative (GFSI), founded in 2000, is
... Read moreIntroduction Prior notice is a requirement for all food manufactured, processed, packed, or held outside the United States that is
... Read moreIntroduction Food classification is a tricky topic. There are so many different names for additives and preservatives, and it can
... Read moreIntroduction: Meeting FSMA compliance requirements is one of the most important things a manufacturer can do to protect their business.
... Read moreIntroduction Health Canada oversees the importation and sale of Veterinary health products (VHPs) in Canada through the VHP Notification Program.
... Read moreIntroduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients.
... Read moreIntroduction to GRAS & NDI An ingredient can get into the diet by being a food, food additive, drug, dietary
... Read moreHACCP, which stands for Hazard Analysis and Critical Control Points, is the cornerstone of food safety plans in the food
... Read moreFood is one of the most important parts of our lives. We eat it to stay alive, and we eat
... Read moreFDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand overview,
... Read moreHow Medical Devices are Classified in Canada Regulatory Classification Basics for your Medical Device: There are certain rules that apply
... Read moreThe Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device
... Read moreThe Canadian Food Inspection Agency (CFIA) is responsible for protecting Canadians’ health and safety by ensuring that food that reaches
... Read moreU.S.A RRA FDA Draft Guidance: In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation of
... Read moreTop Canada Cosmetic Regulations Cosmetic Notification Form (CNF) Canada is one of the most popular tourist destinations in the world,
... Read moreBackground on FDA NAC Warning Letters: Navigating the FDA’s NAC system can be overwhelming. Understanding FDA warning letters is key
... Read moreSay you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is
... Read moreThe Canadian government has a set of regulations in place for natural health products (NHPs). These regulations help to
... Read moreForeign Supplier Verification Program (FSVP) Due to the increasingly global nature of today’s industry, an increasing number of businesses
... Read moreThe Medical Device License is a legal document that is required for the manufacture, sale, and distribution of medical devices.
... Read moreMany drug industries are working in every country. To sell any OTC drug in Canada is not possible without
... Read moreThe FSVP Plan is a requirement for many companies to be FSMA compliant. It is the responsibility of the company
... Read moreNowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems. The
... Read moreQuality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and
... Read moreIndustry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory
... Read morehttps://youtu.be/XRZ87ifRki0 Since the publishing of the Safe Foods for Canadians Regulations in 2017, there is now a requirement for a
... Read morehttps://youtu.be/iojmXU4ZSx4 What is Natural Health Products Ingredients Database (NHPID)? The Natural Health Products Ingredients Database (NHPID) is an electronic tool
... Read more1. What is the NHP Licensing Process/what is needed for it? This process involves the submission of a product license
... Read moreIn this blog, we’ll focus on answering your questions about the SFCR License and Preventive Control Plans, including why they
... Read moreOverview Manufacturers of prescription and non-prescription drugs are required to obtain a Drug Identification Number (DIN) before the drug product
... Read moreMarket Analysis and Overview of CPG Market: Will CBD Products be considered an NHP? The consumer packaged goods (CPG) market,
... Read moreDo you want to learn about the food regulations for food sales in North America? This could include food facility
... Read moreWho needs a Foreign Site Reference Number (FSRN)? For Natural Health Products (NHPs) manufactured, packaged, and/or labeled by sites located
... Read moreAs a license holder for Natural Health Products (NHPs), it is your responsibility to be aware of and educated on
... Read moreThis blog unpacks the distinctions between NHPs, Health Canada & FDA-approved drugs, and cosmetic product regulations that define these products.
... Read moreEver wonder why Why Food Labels are Important? Food labels provide important information about the food we eat, such as
... Read moreWhat is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
... Read moreIntroduction: The market for animal and pet products is growing at a rapid pace. With that, there is also a
... Read moreWhat is HACCP? A common question that comes up in regulated industries, such as food manufacturing and processing, is “What
... Read more1. What are over-the-counter drug products (OTC drugs)? Non-prescription drugs also called over-the-counter (OTC drugs), are health products that can
... Read moreIntroduction Dietary supplements in the USA are very similar to natural health products (NHP regulations) in Canada and many products
... Read moreWhat is a Cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
... Read moreTop 5 Tips to Successfully Secure an NPN Number In order to sell a Natural Health Product (NHP) in Canada
... Read moreIntroduction The purpose of this guidance document is to give stakeholders directions on how to be compliant with Natural Health
... Read moreRegulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines
... Read moreWhat is a claim? A claim is a representation for sale. It can be presented as “a word, a sentence,
... Read moreIn general, all drug products (including over-the-counters and biologics) must be authorized for sale by Health Canada, before they can be
... Read moreAll Natural Health Products (NHPs) sold in Canada are subject to the Natural Health Products Regulations (NHPR). Natural Health Products
... Read moreMedicinal Mushrooms in powder, capsule or liquid form can be licensed as Natural Health Product (NHP) in Canada. To sell
... Read moreWhat is a Cosmetic? Cosmetics are a part of just about everyone’s life. Every day, most of us use products
... Read moreThe classification of Foods and Natural Health Products (NHPs) can be considered difficult, grey, and convoluted. Sometimes even comes down
... Read moreThe US Environmental Protection Agency (EPA) is saddled with the responsibility to register pesticides in the US. This process is
... Read moreAs a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
... Read moreWhat to Expect After Submitting an NPN Application In order to sell a Natural Health Product (NHP) in Canada, you
... Read morePet Foods and Human Food Labels are designed to look similar yet distinct. There are some similar label requirements and
... Read moreThe advancement of technology is rapidly progressing, and the evolution can be observed all around us. As cutting-edge technology becomes
... Read moreHow to Minimize the Risk of Border Detention Shipping Consumer Packaged Goods As an importer of consumer packaged goods, unanticipated
... Read moreInspection of your food facility will help identify and fix any quality or processing deviations found regarding food safety. Review
... Read moreWhat is Hemp Seed Oil categorized as in Canada? In Canada, Hemp (Canna Sativa) seed oil can be categorized as
... Read moreAdvertising is something almost all people experience and view daily. Yet, it can be challenging to navigate this space as
... Read moreWho Needs an MDSAP Certificate? Anyone looking to manufacture a Class II, III or IV medical device in Canada requires
... Read moreIn the world of compliance and quality management, audits are a fact of life. Auditing verifies adherence to standards or
... Read moreAnimal Supplements in the USA – What You Need to Know How are animal supplements regulated in the USA? Dietary
... Read moreThe product label is something we all look at in our daily lives, but not everyone is well equipped with
... Read moreHow to Sell Dietary Supplements or NHPs on Amazon or Other Online Platforms in Canada? What is an NHP? In
... Read moreCOVID-19 and Hard Surface Disinfectants – What You Need to Know In Canada, chemical products that are used to clean,
... Read moreNatural Health Products (NHPs) are regulated by Health Canada under the authority of the Food and Drugs Act and the Natural
... Read moreConventional Foods vs. Supplemented Foods The easiest way to know the difference between these categories are that Conventional foods are
... Read moreIdentifying the correct application type has become increasingly more crucial for Natural Health Product (NHP) applications. Incorrect classification can result
... Read moreHealth Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is
... Read moreEarlier this summer, Health Canada provided a notice to industry on the regulatory considerations for non-medical masks or face coverings,
... Read moreWhat is a HACCP Plan? Food safety is always evolving and becoming more complex, as companies require constant updating with
... Read moreWith the need for hand sanitizers significantly increasing for healthcare personnel and individuals during the current COVID-19 pandemic do help
... Read moreThe 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
... Read moreAll marketed drugs and health products have benefits and risks. All health products are carefully evaluated before they are licensed
... Read moreAll drugs subject to the Food and Drug Regulations are required to gain premarket authorization prior to issuance of a
... Read moreWhen Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the
... Read moreThe label and package are the first points of interaction between a health product and a consumer. Prior to the
... Read moreIn continuation to the last article on Canadian legislations and requirements regarding the marketing of drugs and medical devices, this
... Read moreHealth Canada is not only the national regulatory authority for issuing health product marketing authorizations, but it also oversees and
... Read moreUnder the Food Safety Modernization Act (FSMA), the United States (U.S.) started graduated enforcement of the Foreign Supplier Verification Program
... Read moreNatural Health Product Brand Name Guidance Brand names are an important part of your marketing strategy, but as many of
... Read moreThe Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into
... Read moreWhen it comes to topical essential oils, determining the correct regulatory pathway to ensure full compliance typically depends on how
... Read moreThe European Food Safety Authority (EFSA) is a world renowned regulator which is known for its high scientific standards when
... Read moreSupplemented foods and natural health products (NHPs) can sometimes pose challenges when trying to determine the correct regulatory pathway to
... Read moreThe Canna Regulations were officially published in Canada Gazette Part II on July 11, 2018. The regulations outline several different
... Read moreSummertime has finally arrived and with it comes hot temperature and intense ultraviolet rays. Exposure to ultraviolet light is known
... Read moreThe Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into
... Read moreHealth Canada implemented the Plain Language Labelling (PLL) initiative to help make the labels for non-prescription health products easier to
... Read moreYou might have heard a little something in the news recently about the legalization of Canna coming to Canada. Needless
... Read moreIn October 2014, the Natural and Non-prescription Health Products released a policy to manage the overall application review process. It
... Read moreHydrolyzed collagen and gelatin are animal-based proteins that have recently gained popularity within the food and supplement industry. Gelatin and
... Read moreJust a little background information first before I talk about the business aspect of capitalizing on your NPN. NPN stands
... Read moreIn the winter and spring of 2017 Health Canada inspectors visited 23 companies. The program was called a compliance monitoring
... Read moreQuality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.