[Green Circle Talks About Crossing the Border] Regulation of Pharmaceutical Products and Cosmetics in Japan

Below is a detailed description of "Extra-medical Products and Cosmetics":

Laws and Regulations

• PMD Bill: Laws and regulations on quality, efficacy and safety assurance of medicines, medical devices, regenerative and cellular therapy products, gene therapy products and cosmetics.

Qualification Requirements

• Pharmaceuticals: Labeled as "Extra-medical Product" after being licensed for the manufacture and sale of Extra-medical Products.
• Cosmetic: Japanese labels are required.

Compliance Product Demonstration

1. Acquisition of Extra-medical Products::

• Goods used for the prevention of nausea and other discomforts or for the prevention of bad breath or for deodorizing the body; goods used for the prevention of prickly heat or ulcers; goods used for the prevention of hair loss, the promotion of hair growth, or for the removal of hair, and which do not belong to a medical device or instrument.
• Goods for the health of humans and animals to eliminate rats, flies, mosquitoes, fleas, or other similar animals or insects, and which are not medical devices or instruments.

1. Approved Veterinary Extra-ordinary ProductsThe
2. Cosmetics with essential cosmetics labelingThe

High Risk Product Range

1. Unapproved Extra-medical Products or Cosmetics::

• Merchandise that meets the definition of a medical device or cosmetic under the PMD Act because it contains an ingredient or advertises an efficacy for use as a medical device or cosmetic, but has never received the necessary approval or submitted the necessary notifications, etc.
• Other extra-medical or cosmetic products that are prohibited from being advertised or sold in Japan.

1. Repackaged goods: It is prohibited to take ready-made goods out of their containers or packages and split them into multiple packages for sale.
2. Commodities Used to Cheat on Stimulant TestsSuch as urine additives and synthetic urine.
3. Inclusion of substandard, misbranded or mislabeled goodsThe
4. Products that have not been approved by the Ministry of Health, Labor and Welfare or any other regulatory agency for promotional use or sale.The
5. Goods that have been determined by the Ministry of Health, Labor and Welfare or other regulatory agencies to be a potential safety hazard or goods containing such ingredients.These goods may be unreasonably described as causing injury or illness or otherwise present a safety hazard.
6. Goods containing controlled substances whose promotion or sale is prohibited by laws and regulations.The
7. Goods whose expiration/warranty dates or use-by dates have expired.The
8. Goods that have been opened or show signs of use.The
9. Goods not sealed in the manufacturer's original packagingThe
10. Merchandise with part or all of the original packaging missingFor example, goods for sale without an outer packaging box.
11. Test items, non-sale items or items not for resaleThe following are some examples of the types of merchandise that may be sold in the U.S., or that are labeled as testers, not for sale, or not for resale.
12. Goods lacking some or all of the labeling required by lawFor example, goods whose serial numbers, which are required to be on the manufacturer's original packaging, are blacked out and difficult to recognize, and goods intended for foreign markets that do not have all of the Japanese language labels required by law.
13. Merchandise that has been recalled or received a safety warning or warning letterThe
14. Cannabis products whose possession is prohibited by lawFor example, commodities containing tetrahydrocannabinol (THC).
15. Products found to contain THC in the pastThe product range includes items from the same brand and collection.
16. Goods containing substances considered to have effects similar to those of controlled substancesThe

These instructions should cover everything in the form. If there are any other parts that need to be explained, please contact the Green Circle.