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This article applies to selling in: Japan

Drugs

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

Examples of Permitted Listings

For listing for the sale of over-the-counter drugs ("OTC drugs"), you must have drug retailer license or pharmacy establishment license according to the PMD Act (*) of Japan. You also need to provide the required information on the retailer details page. Further listing OTC drugs are authorized to sellers that are pre-approved by Amazon. Sellers who have pre-approved by Amazon can only sell OTC drugs which described on the OTC drug lists provided by Amazon. Products must have the PMD Act 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. For more information, please see the following link:

https://images-na.ssl-images-amazon.com/images/G/09/rainier/help/OTC_Drugs_Guidelinel._TTH%20_.pdf

(*)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).

Examples of Prohibited Listings

  • Illegal drugs and dangerous drugs, such as:
    • Narcotics and Psychotropics defined under the Narcotics and Psychotropics Control Act of Japan, Cannabis defined under the Cannabis Control Act of Japan, Opium and Opium poppy defined under the Opium Act of Japan, Stimulants defined under the Stimulants Control Act of Japan, Poisonous and Deleterious Substances defined under the Poisonous and Deleterious Substances Control Act of Japan and products which contain specified drugs and specified drugs under the PMD Act of Japan.
    • Products specified or reported by the MHLW (Ministry of Health, Labour and Welfare) or any or the other regulatory agencies as dangerous drugs (including products called loophole hallucinatory herbs or legal drugs).
    • Similar products that Amazon does not allow to sell.

      For more information, please see the following links as well as the related laws and regulations:

      The MHLW sites (Japanese):

      http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/yakubuturanyou/

      Tokyo Metro Bureau of Social Welfare and Public Health "Dangerous Drug Notices" (Japanese):

      http://www.fukushihoken.metro.tokyo.jp/kenkou/kenkou_anzen/d_taisaku/index.html

  • Unapproved Drugs
    • Products which contain pharmaceutical ingredients used for drugs or advertise medical efficacy and thus fall under the definition of drugs under the PMD Act, but have never obtained necessary approval etc.
    • Other medicines which are not allowed to advertise or sell in Japan.

      For more information, please see the following link (Japanese):

      http://www.mhlw.go.jp/kinkyu/diet/musyounin.html

  • Pharmacist's Intervention Required Drugs or Class 1 OTC Drugs.
  • OTC Drugs which Amazon does not allow to sell.

    Only those sellers who have pre-approved for listing Drugs by Amazon.co.jp are allowed to list them. Please note that if you list Drugs without pre-approval, your listing will be canceled and also we suspend your account without prior notice due to guideline violation.

    For more information, please see the following link provided by Amaoaon.co.jp (Japanese):

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

  • Ethical Drugs including Prescription Drugs

    For more information, please see the following Ethical Drugs search engine site (Japanese):

    http://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html

    For more information, please see the following JAPIC site (Japanese): http://www.japic.or.jp/

  • Veterinary Products that are not allowed to sell by Amazon.co.jp

    To list drugs for animals, you must have animal drug retailer license according to the PMD Act. You also need to provide the required information on the seller details page. Products must have the Laws required labeling and are not otherwise restricted from selling or advertising under the Laws and all the Amazon policies. For more information, please see the following links.

    Guidelines for product registration (for pet product stores) (Japanese):

    https://s3.amazonaws.com/seller-guide/jp/MA10052W/MA10052W.pdf

    The Ministry of Agriculture, Forestry and Fisheries' "Summary of the revised Pharmaceutical Affairs Law regarding the online sale of drugs for animals" (Japanese):

    http://www.maff.go.jp/j/syouan/tikusui/yakuzi/internet_hanbai.html

  • Products that require a prescription or a medical professional's supervision or direction for their purchase and use (except contact lenses).
  • Prescription drugs that are manufactured and sold abroad.
  • Repackaging Drugs.

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

  • Acting for personal imports.

    Acting for personal imports, adopting a similar method for listing products, or shipping imported products to a buyer (a seller in Japan receives orders and another seller outside of Japan ships products to a buyer) is prohibited.

    For more information please see the relevant laws and MHLW page below(Japanese):

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

  • Prohibited imports by customs (Japanese):

    http://www.customs.go.jp/mizugiwa/kinshi.htm

  • Prohibited products (to be shipped internationally) by Amazon.com (English)

    Drugs & drug paraphernalia

  • Products intended to defeat a drug test, such as urine additives and synthetic urine.
  • Products that are adulterated or misbranded.
  • 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.
  • Listings claiming that a product is intended to be used for the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals unless the claim is approved by laws or the MHLW or any or the other regulatory agencies.
  • 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.
  • "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 that do not have a required labeling.
  • 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 marketed in a manner that imitates the effects of a controlled substance, prescription drug, or substance identified by the MHLW or the other regulatory agencies as an unapproved new drug or tainted supplement.
  • Products marketed to imitate a prescription drug or prescription drug brand.
  • COVID-19 Antigen/Antibody Test Kit that falls under an in vitro diagnostics
  • COVID-19 Antigen/Antibody Test Kit (miscellaneous goods) for research that fall into any of the following conditions;
    • Products that are not explicitly marked “for research use only” in the product name.
    • Products that do not explicitly marked the COVID-19 Antibody/Antigen Test Kit.
    • Products that have a description as if it can be determined whether or not they are currently infected with the COVID-19 by using this test kit.
    • Products with a display that this test kit is approved by the Ministry of Health, Labour and Welfare, or may cause such misunderstandings.
    • Products for which all of the following notes are not listed in the bullet point on the product page.
      • This kit is intended for testing research for epidemiological research, and is not intended to diagnose diseases, so it should not be used for the purpose of investigating the presence or absence of the COVID-19 infection.
      • If you have symptoms such as fever and you suspect that you are infected with the COVID-19, please consult a consultation center or a medical institution.
      • If you do not have symptoms such as fever and wish to take tests related to the COVID-19 infection, visit a medical institution or a partner medical institution that provides the test (self-expense examination) to be taken at your own expense.
    • Products that require additional procedures, such as sending samples after purchase that Amazon does not allow to sell.
    • Products that have illegal marketing claims (i.e., cure, mitigation, treatment, prevention, improvement, etc.) related to the COVID-19 and other diseases.
  • Products containing cannabidiol (CBD).
  • Other products that Amazon does not allow to sell.

Additional Useful Information

Related Amazon Help pages

Restricted Products: Quasi Drugs & Cosmetics

Restricted Products: Dietary Supplements

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