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Search for "Pre-market Approval" related English Translations
43 results found
Most Popular
Lastest Update
Cosmetic Hygiene and Safety Act
Jul 04, 2019
EN
Taiwan Cosmetic Hygiene and Safety Act was released on May 2, 2018 and implemented on July 1, 2019. This is the newest cosmetic overarching regulation in Taiwan, amending cosmetic definition, classification, pre-market requirements, GMP, enterprises' obligations, illegal claims, advertisements and labels, etc., which will definitely have great influences to cosmetic enterprises want to enter Taiwan market.Read the 8 key amendments at CL News.
Taiwan, China
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
Manufacturer/Importer Regulation
Advertising
Administrative Measures for Filing of Non-special Use Cosmetics (Draft)
Jun 06, 2019
EN
Administrative Measures for Filing of Non-special Use Cosmetics (Draft) aims to standardize the regulation of non-special cosmetics filing nationwide. The draft version has 5 Chapters and 30 Articles with an attachment, mainly involving the filing process, the filing materials, relevant safety assessment and etc.
Chinese Mainland
Pre-market Approval
Animal Testing
Safety Assessment
Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (2019.09.20)
Dec 04, 2018
EN
The document is the enforcement regulations of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. Note: This translation was published by Japanese Law Translation and is an unofficial text. The translation is only updated to the 2015 revision while the revised edition of 2019 is in effect. This document should only be used as a reference for understanding Japanese regulations and in case of any discrepancy between the English and Japanese versions the original Japanese version shall prevail.
Japan
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
Manufacturer/Importer Regulation
Animal Testing
Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (2018.12.30)
Dec 04, 2018
EN
This document is the order for enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. The Cabinet hereby enacts this Cabinet Order pursuant to the provisions of Article 2, paragraph (4), Article 11 (including as applied mutatis mutandis pursuant to Article 38), Article 28, paragraph (2), Article 30, paragraph (3), Article 43, paragraph (2), Article 67, paragraph (1), Article 77, paragraph (3), Article 78, paragraph (1), Article 80 and Article 82 of the Pharmaceutical Affairs Act (Act No. 145 of 1960). Note: This translation was published by Japanese Law Translation and is an unofficial text. The translation is only updated to the 2015 revision while the revised edition of 2016 is in effect. This document should only be used as a reference for understanding Japanese regulations and in case of any discrepancy between the English and Japanese versions the original Japanese version shall prevail.
Japan
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
Manufacturer/Importer Regulation
Management Requirements for Sun-protection Effect Labeling of Sunscreen Cosmetics
Nov 14, 2018
EN
This standard specifies the management requirements of sun-protection effect labeling for sunscreen cosmetics.
Chinese Mainland
Pre-market Approval
Labeling/Claim/Advertising
Guidance of Filing Management for First Import Non-special Use Cosmetics through Shanghai Pudong (EN Version Available)
Mar 26, 2018
EN
This Guidance is applicable to the application for and handling of relevant service concerning the filing management of imported non-special use cosmetics in Pudong New Area of Shanghai.
Chinese Mainland
Pre-market Approval
Pudong Filing
QB/T 1685-2006 Requirements of Packaging Appearance for Cosmetic Products
Dec 28, 2017
EN
This standard is a revision of QB/T 1685-1993: Requirements of packaging appearance for cosmetic products. Compared with QB/T 1685-1993, this standard made the following main changes: ---Added spray head (including pneumatic, pump) types in packaging category; ---Deleted 3.11 in the former standard; ---Modified visual test method.
Chinese Mainland
Pre-market Approval
Testing
Measures for the Metrological Supervision and Administration of Quantitatively Packed Commodities [Effective]
Dec 28, 2017
EN
For the purpose of protecting the lawful rights and interests of consumers, manufacturers and sellers, regulating the metrological supervision and administration of quantitatively packed commodities, these Measures are formulated pursuant to the Metrology Law of the People's Republic of China and by reference to the prevailing international practices. Within the territory of the People's Republic of China, the production and selling of quantitatively packed commodities, and the metrological supervision and administration of quantitatively packed commodities shall be in accordance with these Measures. The term "quantitatively packed commodities" as mentioned in these Measures refers to pre-packed commodities for selling with uniform mass, volume, length, acreage, numbering label and other marks within a certain quantitative scope.
Chinese Mainland
Pre-market Approval
Provisions for Application and Acceptance of Administrative Licensing for Cosmetics
Mar 12, 2015
EN
The requirements are applicable to the acceptance work of cosmetic administrative license stipulated in the Regulations concerning the Hygiene Supervision over Cosmetics and its Detailed Rules, are laid down in order to further standardize the application and acceptance of administrative licensing for cosmetics and to guarantee its publicity, fairness and impartiality. The cosmetic administrative license refers to the examination and approval of the use of new cosmetic raw material, production of domestic special cosmetics and the importation of cosmetics for the first time. Besides, the obligations of application, extension, modification, reissue of a hygiene license document (record keeping certificate) are also clearly stated.
Chinese Mainland
Pre-market Approval
Manufacturer/Importer Regulation
Requirements for Management on Whitening Products
Jan 29, 2015
EN
Whitening products are reclassified as special use cosmetics and fall into the category of spot-removing products. From 30 June 2015, the manufacture and import of whitening products without an accompanying special use cosmetic certificate will be banned. This regulation stipulates the requirements for management on whitening products.
Chinese Mainland
Pre-market Approval
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