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This article applies to selling in: Japan

Quasi Drugs & Cosmetics

Note: All listings and products must comply with all laws and regulations and Amazon policies.

Examples of permitted listings

Following products that have the Pharmaceutical and Medical Device Law(*) and other laws and regulations, administrative interpretations and guidelines ("Laws")- required labeling and are not otherwise restricted from selling or advertising under the Laws and all the Amazon policies.

  • Quasi Drugs
  • Designated Quasi Drugs
  • Quasi Drugs for prevention or extermination
  • Quasi Drugs for animals
  • Cosmetics

(*)Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (PMD Act) of Japan (Act No. 145 of 1960, as amended)

Regarding a required labeling for Quasi Drugs and Cosmetics, please see the following link as well as the Laws:

Tokyo Metropolitan Institute of Public Health: Required labeling for Quasi Drugs (Japanese)

http://www.tokyo-eiken.go.jp/k_yakuji/i-kanshi/bugaihin/b-hyouji/

Tokyo Metropolitan Institute of Public Health: Required labeling for cosmetics (Japanese)

http://www.tokyo-eiken.go.jp/k_yakuji/i-kanshi/cosme/c_label/

Article 59 and 61: Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices: (Japanese/ English)

http://www.japaneselawtranslation.go.jp/law/detail_main?re=&vm=&id=3213#ja_ch9sc3at1

http://www.japaneselawtranslation.go.jp/law/detail_main?re=02&vm=03&id=3213#ja_ch9sc4at1

Article 218, 220-2 and 221-2: Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Japanese/ English)

http://www.japaneselawtranslation.go.jp/law/detail_main?re=02&vm=03&id=3215#ja_ch7at24

http://www.japaneselawtranslation.go.jp/law/detail_main?re=&vm=&id=3215#ja_ch7at31

http://www.japaneselawtranslation.go.jp/law/detail_main?re=02&vm=03&id=3215#ja_ch7at34

Examples of prohibited listings

  • Unapproved Quasi Drugs or Cosmetics
    • Products which contain ingredients used for Quasi Drugs or Cosmetics or advertise effect-efficacy and thus fall under the definition of Quasi Drugs or Cosmetics under the PMD Act, but have never obtained necessary approval or submitted necessary notification etc.
    • Other Quasi Drugs or Cosmetics which are not allowed to advertise or sell in Japan
  • Repackaging products

    Taking off-the-shelf products from their containers or encapsulations and splitting them into multiple packages for sale is prohibited

  • Unauthorized imported products

    Shipping imported products to a buyer or adopting a similar method for listing products (a seller who doesn’t have a marketing license for quasi drugs (when selling quasi drugs) or a marketing license for cosmetics (when selling cosmetics) in Japan receives orders and another seller outside of Japan ships products to a buyer) is prohibited. For more information, please see the following link (Japanese):

    https://www.mhlw.go.jp/kinkyu/diet/tuuchi/0828-4.html

  • Beauty store products that Amazon.co.jp prohibits (Japanese):

    https://images-na.ssl-images-amazon.com/images/G/09/rainier/help/NoParallelImportBrands_jp_beauty.xlsx

  • Products intended to defeat a drug test, such as urine additives and synthetic urine
  • Products that are adulterated, misbranded or mislabeled
  • Products that have been the subject of a prior US regulatory action, such as:
    • Food and Drug Administration (FDA) warning letters, safety alerts, or recalls
    • Drug Enforcement Administration (DEA) emergency scheduling
    • Federal Trade Commission (FTC) orders or guidance
  • Products that are unapproved for advertisement, use or sale by the MHLW or any or the other regulatory agencies
  • Products and products that contain ingredients that the MHLW or any other regulatory agencies have determined present an unreasonable description of injury or illness, or are otherwise unsafe

    Regarding the regulations on advertisement of Quasi Drugs or Cosmetics, please see the following link (Japanese) as well as relevant laws and regulations:

    Tokyo Metro Bureau of Social Welfare and Public Health: Standard for Adequate Advertisement of Pharmaceutical Products

    http://www.fukushihoken.metro.tokyo.jp/kenkou/iyaku/sonota/koukoku/index.html

    Tokyo Metro Bureau of Social Welfare and Public Health: Advertising seminar materials for Drugs, Quasi-drugs, Cosmetics and Dietary Supplements

    https://www.fukushihoken.metro.tokyo.lg.jp/kenkou/iyaku/sonota/koukoku/siryou.html

  • Products that contain controlled substances that are not allowed to be advertised or sold pursuant to laws or regulations
  • Products that have passed their expiration or use-by dates
  • Opened or used products
  • Products that are not sealed in original manufacturer's packaging
  • Products in which part or all of the manufacturer's original packaging is missing. For example, a product that is sold without an outer box
  • "Tester," "Not for retail sale," or "Not intended for resale" products and products labeled as "Tester," "Not for retail sale," or "Not intended for resale"
  • Products for which part or all of the labeling required by law is missing. For example, a product whose required serial number on the manufacturer's original packaging is blacked out and unreadable. A product for foreign markets that doesn’t have all of the labeling in Japanese required by law.
  • Products that have been the subject of recalls or safety alerts or warnings
  • Products that have been the subject of criminal enforcement, injunctions, or seizures
  • Products containing cannabidiol (CBD)
  • Other products that Amazon does not allow to sell

Related Amazon Help pages

  • Restricted Products: Drugs
  • Restricted Products: Dietary Supplements
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