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Disinfectants and disinfection of disposable hand sanitizer exports the United States, need to be prepared for these?

by:Zanyu     2020-09-28
Disinfectants and disinfection of disposable hand sanitizer exports the United States, need to be prepared for these? After more than a month to the national people's solidarity, hard fight, domestic epidemic finally gradually ease. However, the new virus has started in the world. Tam kung plug in 11, the world health organization director-general, said the new crown pneumonia outbreak has has the characteristics of a global pandemic, but it is also the first in history can control of the pandemic. Prevent new coronavirus, in addition to the effective isolation, correct disinfection is one of the very important control measures. The European and American countries although have been denied the validity of the mask, but agree to wash their hands or hand disinfection is a very effective method. Show that disposable disinfectant hand sanitizer this kind of product has begun foreclosures in various countries. In order to let more compliance disinfectant products o science and technology in the near future can smoothly enter the market demand has been focusing on the various countries and regions of disinfectant for listing rules, today, we know the main disposable disinfectant hand sanitizer, export to the specific requirements of the United States. Disposable disinfectant hand sanitizer exports to America's demand in the United States, the local disinfection of disposable disinfectant hand sanitizer belongs to over-the-counter drugs ( 场外,- - 计数器) With dandruff shampoo, fluoride toothpaste, sunscreen, and other products, the food and drug administration ( FDA) Regulation. Although belongs to the drug class, but most of the OTC products or simple compliance requirements. In general, the FDA will review for OTC drugs active ingredient, and eventually issue a monograph on OTC ( 场外专著) 。 OTC monograph is equivalent to active material standard for OTC products, as long as one of the active ingredients to meet the requirements of the monograph on over-the-counter (OTC), can be directly listed is not approved by the FDA. Need to pay attention to, not the FDA approval does not mean that the OTC drugs listed no compliance obligations, products still need to meet certain requirements, specific requirements are as follows: 1, the active ingredient in the OTC drugs must have a ready-made OTC monograph, and active ingredient used in the enterprise meet the requirements of the monograph on OTC OTC drugs or products will do application; For alcohol-based disposable disinfection liquid soap, alcohol in the United States has a corresponding OTC monograph, so long as to meet the requirements of the monograph, used in the production of alcohol products can keep the FDA approval. 2, OTC drug manufacturers or importers and exporters to FDA site registration, for companies outside the United States, you need to entrust the FDA site registration agent within the territory of the United States. 3, for OTC drugs to apply for a national drug code ( NDA,国家药品代码) 。 4, enterprises must take all OTC medicines list will be entering the U. S. market and the FDA for backup, after this listing to update in June and December every year twice. 5, OTC drugs tag must conform to the relevant provisions of the 6, production factory must satisfy dynamic pharmaceutical production management specification ( cGMP) Overall, the requirements for production factory has meet cGMP requirements of the enterprise, the remaining five compliance obligations are relatively simple to contribute with you together o o science and technology has an independent subsidiary in the United States, American agents can serve as the general enterprise, assist the company to complete the FDA registration and other compliance related matters, the time required to the whole process of compliance will be in a month or so. The current world is suffering from a new type of coronavirus, epidemic situation grim, o science and technology has always been willing to use our professional ability, to contribute to this virus battle. We the deepening European Union, the United States, China disinfectant compliance field for many years, has a professional technical team and rich experience in the declaration, power disinfectant enterprise smoothly into the market demand, can hope to help people around the world have more choose and use disinfectant products, spend outbreak! Tags: disinfectant disinfection of disposable hand sanitizer exports
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