Japan to Adjust Cosmetic/Quasi Drug Manufacture and Sale Licenses Application Requirements

  •   18 Apr 2017
  •    Jo Zhou

    Take home:

    To align with the revised “Standard for Quasi Drug Ingredient 2006”, Japan MHLW will adjust the requirements for cosmetic manufacture and sale license applications.

    The revision of “Standard” amends 11 testing methods and 10 quality requirements of ingredients. This “Standard” will be implemented Sep.30 2018 after a grace period (more details see: CL).

    Therefore, if an enterprise applies for “manufacture and sale license” before Sep. 30, 2018, it can fill out the application form (“ingredient” and “testing method” columns) referring to the previous “Standard”, but afterwards the applicant must fill out the application form in compliance with new requirements.

    For enterprises which have already obtained the “manufacture and sale license”, the information on the supporting documentation relating to ingredients and methods can remain unchanged until Sep.30 2018. Starting from Oct. 1 2018 all information on the license must be in compliance with new “Standard”. In case of any modification to manufacturing or sales activities, the amendment to the license should follow the new standard.

    In addition, one testing method called “filter paper chromatography” will change its name (will be published soon). Enterprises should use the new name when filling out the application documents. One ingredient called “Polyethylene chloride dimethyl methylene piperidinium solution” is now called “Polyvinyl chloride dimethyl dimethylene pyrrolidinium solution” and new applications should use the new designation.