China Chemical Regulatory Guidance

Page 167

Hygienic Administrative Licensing for Imported disinfectants II

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Imported Disinfectant Product Hygienic License

卫消进字

Please be noticed: This application form applies to 1. Cosmetics products 2. Disinfectant and disinfecting apparatus 3. Products involved drinking water

The 1st case

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1) Documents issued by the authority from the original place where disinfectants were manufactured should be provided as evidence in case of company name or seat change. Contract could also be valid in case of company name change resulting from mergence etc.

Other materials to be provide Case 1: Company name or Company seat changes

All documents used as evidence should be translated in Chinese and then formally notarized in China.

Case 2: Chinese name of imported disinfectant changes The reason of name change should be specified in the Application Form, and provide re-designed packaging of the product; Foreign name shall be remained unchanged.

2) If the subsidiary is invested by companies located in HK Macao or other places out of China Mainland, “Certificate of Approval for establishment of enterprises with foreign investment in the PRC” is a must. 3) Regarding changes of manufacturing sites,, hygienic testing report of imported disinfectants produced in the new site is a must. Testing over 3 batches of disinfectants for active ingredients, Ph value s and stability are required . The authority may put an onsite inspection over manufacturing place in some cases.

Original Product Hygienic License (卫消进字)

Case 3: Other content changes Reason of content change should be detailed and provide related documents.

If notified through authorized agent, then authorization letter is a must

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www.moh.gov.cn/publicfiles/business/htmlfiles/zwgkzt/pxzxke/200804/33326.htm

One original copy of each submitted material


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