Following our previous alert on the FDA’s announcement regarding the transfer of cosmetic data from Hello to Privus system, and the renewal of cosmetic notification licenses before 8 September 2018, the FDA has now issued the Ministerial Notification re: Rules, Procedure, and Conditions to Manufacture or Import Cosmetics, as published in the Government Gazette on 23 May 2018, stipulating guidelines for local manufacturers and importers to arrange their manufacturing facilities, importer's offices and cosmetic storages.

Furthermore, the FDA requests immediate actions from local manufacturers and importers as follows:

  1. Local manufacturers and importers whose cosmetics were already notified to the FDA before 24 May 2018 must confirm their identity with the FDA or the provincial health offices by submitting documents such as a company certificate, map showing the location of the premises, and floor plans of the office and cosmetic storage area. If they no longer manufacture or import cosmetics, a formal confirmation of the cancellation of all cosmetic notification licenses must be submitted. The FDA will soon send a letter to each local manufacturer and importer to contact the FDA within 45 days after receiving the letter. Failure to do so will result in the termination of all cosmetic notification licenses.
  2. New local manufacturers and importers who wish to start cosmetics businesses after 24 May 2018 must register themselves with the FDA as manufacturers or importers of cosmetics before they can proceed with the notification of cosmetic formulas. Checklists of documents and materials required for registration, along with guidelines on how to arrange manufacturing facilities, import offices, and cosmetic storages, have now been made available.

 


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