FDA Withdraw The New OTC Monograph User Fee for FY 2021 January 5, 2021 Update: FDA decided to withdraw their newly published OMUFA fees on December 29, 2020 Federal Register Notice entitled “Fee Rates Under the Over-the-Counter Monograph User Fee Program for Fiscal Year 2021″ till further notice. In the past March, President Trump […]
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FDA Cosmetic Approval: What You Need to Know About The FDA regulates drugs and cosmetics, but when a cosmetic is considered a drug, it can become difficult for manufacturers to discern whether their product is classified as an FDA OTC drug or a cosmetic and if requires FDA cosmetic approval. FDA OTC Drug product regulation
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FDA Food Facility Registration Renewal: October 1 to December 31, 2020 FDA registration renewal is due between October 1 and December 31, 2020 for all food facilities. The renewal is required for any facilities that engage in the following US food for consumption activities: • Manufacturing • Packing • Processing • Storing Renewing the FDA
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UK Cosmetic Regulations: What You Need to Know On January 31, 2020, the United Kingdom and the European Union signed a cosmetic regulation. The changes will not have an impact on UK cosmetic regulations initially due to a transition period. The period lasts for one year and, can be extended for an additional year as
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Cosmetic Notification Form CNF Canada Canadian cosmetic regulations encompass products that are sold for use in skin, hair, teeth, perfumes, cleansing and more. Product compliance requires filling out the free cosmetic notification form CNF and notifying Health Canada. If the product is not properly notified, the product cannot be sold in Canada. Canada Cosmetic
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Hand Sanitizer Regulations Canada: Expedite Product License Ended Health Canada announced that from the 13th of July hand sanitizer regulations measures to expedite hand sanitizer product licenses have been suspended. The decision was made because Health Canada believes that there is enough supply of hand sanitizer in the market. Read more : Cosmetic Labelling Canada
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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 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 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 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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