Cosmereg, Author at Cosmereg

FDA Imposes New Yearly Charges for OTC Monograph Drug Establishment

FDA Imposes New Yearly Charges for OTC Monograph Drug Establishment This article has been updated on the 5th of January 2021 https://cosmereg.com/fda-withdraw-the-new-otc-monograph-user-fee-for-fy-2021/ In the past March, President Trump had signed a pandemic aid act named “CARES”. This act featured a measure that reshapes and upgrades the manner specific OTC and non-prescription drugs are […]

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FDA registration requirements to import face masks

US FDA Medical Devices / By Cosmereg

FDA registration requirements to import Face Mask Guidelines to import face mask and FDA registration Non-surgical Face mask (no EUA required) Register as an importer, and have your manufacturer the FDA registration as a medical device manufacturing establishment with FDA. List the medical device product that you intend to import. (FDA’s fee is

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Health Canada Hand sanitizer Registration

Canada Dietary Supplement NHP NPN / By Cosmereg

Health Canada Hand Sanitizer Registration Temporary expedited approval for non-compliant products Health Canada took the decision on Wednesday the 18th of March to allow temporary access to hand sanitizers, disinfectants that don’t fully meet standard regulatory requirements. This measure is due to the shortage of these products during the COVID-19 pandemic. In Canada, hand sanitizers

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FDA hand sanitizer registration

USA Cosmetic Regulations / By Cosmereg

FDA hand sanitizer registration US FDA sets temporary regulations for alcohol-based Hand Sanitizer Because of the actual emergency situation caused by the COVID-19 in the United States, we are receiving a lot of inquiries about the FDA hand sanitizer registration process of Hand and wipe Sanitizer. So In this sense, the FDA issued a temporary policy

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What is the active ingredient in all fda approved hand sanitizers?

US FDA OTC regulations / By Cosmereg

What is the active ingredient in all FDA approved hand sanitizers? FDA issued a final rule on April 11 regarding ban certain dangerous active ingredients in OTC hand sanitizer products. After reviewing the safety and effectiveness of hand sanitizers, the normative concluded a previous determination from FDA that, 28 active ingredients, including triclosan and benzethonium chloride,

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FDA Sunscreen Regulations and Requirements in US

US FDA OTC regulations, USA Cosmetic Regulations / By Cosmereg

New FDA Sunscreen Regulations in the near future: What you need to know? Sunscreen products are classified as over-the-counter OTC products. FDA just released a new proposal of FDA sunscreen regulations. The proposed law requires products to be safe and effective. This update means that all non-approved sunscreen products currently sold in the US market

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FDA Food Labeling Changes: What Businesses Should Know

US FDA food regulations / By Cosmereg

FDA Food Labeling Changes: What Businesses Should Know The FDA food labeling changes impact businesses that have $10 million in annual revenue or more per year. Businesses must meet FDA food label requirements by January 1, 2020. The changes will impact the following on the Nutrition Facts Chart: • Daily values • Serving sizes •

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Is It Mandatory FDA Establishment Registration?

US FDA food regulations / By Cosmereg

Is It Mandatory FDA Establishment Registration? Overview of When FDA Establishment Registration is Required FDA establishment registration varies depending on the FDA regulated product marketed and sold. Various types of FDA facility registration are discussed in the sections below. In general, prior to entering the market a company must classify the product, determine if FDA approval

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Selling Natural Health Products in Canada: What You Need to Know

Canada Dietary Supplement NHP NPN / By Cosmereg

Selling Natural Health Products in Canada: What You Need to Know Consumers are demanding natural health products, and your business is equipped to meet that demand! But what are the requirements for selling a natural health product in Canada? Here are the 3 main requirements you need to know about before your product can

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Should I sell my cosmetics products to Europe or USA first?

EU Cosmetic Regulations, USA Cosmetic Regulations / By Cosmereg

Should I sell my cosmetics products to Europe or USA first? Whether you are a start-up company or an established company in your Home Country it comes the moment where you would like to export your products in new markets and increase your brand awareness or simply you want to sell directly in foreign

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Author name: Cosmereg