Importing Designated Dangerous Drugs

Designated drugs are dangerous drugs designated by the Minister of Health, Labor and Welfare.  For more information on the scope of designated dangerous drugs, please refer to the Ministry of Health, Labor and Welfare’s  website.  The importation of designated drugs for purposes other than medical use is prohibited.  In addition, methamphetamine is regulated by the Stimulants Control Law, marijuana by the Cannabis Control Law, narcotics and psychotropic drugs by the Narcotics Control Law, and opium and poppy seeds by the Opium Law, so they are not considered designated drugs. 

There are products called “legal drugs” that are sold on the Internet, claiming to have hallucinogenic effects, but they often fall under the category of designated drugs even if they do not fall under the category of narcotics, marijuana, or stimulants.  In addition, drugs that do not fall under the category of designated drugs, but they claim to have hallucinogenic effects, it falls under the category of unapproved “drugs” and are prohibited from being sold or advertised to in Japan.

 

Drugs

In principle, importation of drugs such as marijuana, stimulants, narcotics, psychotropic substances, and opium is prohibited.

 

Restricted Subject

Import Regulations

Cannabis Control Law

Marijuana (Cannabis plant, Cannabis plant products)

Importation is prohibited except for marijuana researchers who import with a permit. An import permit or a copy of the permit is required for importation.

Stimulants Control Law (1951)

Stimulant

Import is prohibited

Methamphetamine ingredients (ephedrine)

remarks

Importing requires a permit. Customs requires a “Permit for the importation of methamphetamine materials or a copy thereof.

Individual Purposes

Permission may be granted to carry and import “methamphetamine materials that are medicinal products” for the purpose of treating one’s own illness. Customs requires a “Permit for the importation of methamphetamine materials or a copy thereof.

Import by Designated importers

Designated importers of methamphetamine materials may obtain a permit to import.  Customs will require the import permit or a copy thereof. 

Narcotics Control Law

Narcotic

Remarks

A permit is required for import.

Individual Purposes

Medical narcotics (morphine/fentanyl) may be approved for importation by a person who has been instructed by a physician to take them and carry them as baggage for the purpose of treating his or her own illness. Customs requires a “Portable Import Permit” or a copy thereof.

Licensed drug importers

In the case of importation by a licensed drug importer, an import license is required, and customs will require an import permit or a copy of the permit.

Psychotropic drug

Remarks

A permit is required for importation.

Individual Purposes

Permission may be granted to carry and import medical psychotropic drugs (diazepam, triazolam) for the purpose of treating one’s own illness. Customs will require an import permit or a copy of the permit.

Licensed psychotropic drug importers

○A permit is required for the importation of psychotropic drugs of the first class.

○For the importation of Class 2 or 3 psychotropic drugs, import approval based on the Foreign Exchange and Foreign Trade Law is required instead of requiring a permit based on the Narcotics Control Law.  In addition, if the government of the exporting country requires an import certificate from the government of Japan, it is necessary to obtain an import certificate and send it to the exporter in the other country.

○When the importation of “Class 1”, “Class 2” or “Class 3” psychotropic substances for which the government of the exporting country requires an import certificate” is completed, a psychotropic substance import completion report must be submitted.

Establishers of psychotropic drug testing and research facilities

○An import permit or a copy of the permit is required.

○When the importation is completed, a psychotropic drug import completion report must be submitted.

Ingredients for narcotic psychotropic drugs

Remarks

At the time of importation of narcotic psychotropic raw materials, an import permit based on the Narcotics Control Law is not required, but an import approval based on the Foreign Exchange and Foreign Trade Law is necessary.

For Business

Purposes

Importers of narcotic ingredients are required to submit a notification at the time of commencement of business, as well as in the case of individual imports of specified narcotic psychotropic raw materials.

For Non-Business Purposes

○No notification of commencement of work is required.

○Notification is required when importing narcotic psychotropic materials that exceed the amount specified for each narcotic psychotropic material.

Opium Law

Opium

Importation is prohibited except for those who have been entrusted by the government. 

Poppy seed

A permit is required for importation.

Please contact us if you have any questions.

Regulations on Importing Veterinary Drugs

For importing veterinary drugs into Japan, the provisions for conventional medicinal products, quasi-drugs, medical devices and medical products for regenerative medicine are applied in the same way.  However, unlike pharmaceuticals, the Ministry of Agriculture, Forestry and Fisheries has jurisdiction over this topic.

1 Importation as a Business

In the case of importing veterinary medicinal products as a business:

  1. The importer is required to obtain a license from the Minister of Agriculture, Forestry and Fisheries for manufacturing and sales. 
  2. For those who manufacture veterinary medicinal products in a foreign country, certification and registration as a foreign manufacturer is required for each manufacturing site. 
  3. The business operator in Japan that manufactures label replacements will need to obtain a manufacturing license and registration.
  4. Approval and certification are required for each veterinary drug product imported.

2 Import other than business purposes

In principle, importation by person without a manufacturing and sales license is prohibited.  However, there are certain exceptions, such as for the purpose of testing and research.   In the case of importation based on such exceptions, import verification is required. 

In addition, import verification is not required in the case of:

  1. the owner of an animal other than the subject animal (dog/cat) may import No more than two boxes or two months’ supply of one pharmaceutical product as a portable product for use with the animal;
  2. a veterinarian or the operator of an animal care facility may import no more than two boxes or two months’ worth of each item of veterinary medicine as a portable product for his/her own use for the purpose of diagnosis, treatment or prevention of disease; and
  3. a veterinarian for his or her own medical treatment, where the animals to be used are other than the subject animals, and where the quantity of veterinary drugs to be imported is six boxes or less for each item

3 Prohibition of Importation

The import of illicit veterinary drugs is prohibited.

4 Prohibition of Advertising

Advertising for unapproved and uncertified drugs, medical devices, and regenerative medicine products is prohibited.

 

Please contact us if you have any questions.

Importing Medical Devices, etc.

Processes for importing medical devices and in vitro diagnostic products into Japan differs depending on if the  import is for business purposes or not.

1 Imports as a Business

In the case of importing medical devices and in vitro diagnostic products as a business and selling them in Japan.  First, the business operator conducting the importation is required to obtain a manufacturing and sales license.  Secondly, registration of foreign manufacturers is required for each manufacturing site for business operators who manufacture in foreign countries. Third, if there is a business operator in Japan that manufactures label replacement, that business operator is required to register as a manufacturing business.  Fifth, the manufacturer or distributor must submit a notification and make it public with regard to the matters described in the attached document. 

2 Imports other than for business purposes

Import verification is required for imports other than for business purposes.  However, in the case of contact lenses, importation of two pairs (two-month supply for disposable lenses) does not require import verification. You can find more information on the Ministry of Health, Labour and Welfare website.

3 Prohibition of Importation

The importation of illicit medical devices and in vitro diagnostic products is prohibited. 

4 Prohibition of advertisement

It is illegal for overseas distributors to advertise unapproved/uncertified medical devices and in vitro diagnostic products on sales websites, even to those in Japan. In many cases advertising by import agents is also illegal. 

Please contact us if you have any questions.

Importing Regenerative Medicine Products

The processes for importing regenerative medicine products into Japan differs depending on if the  import is for business purposes or not.

1 Import as a Business

When importing a regenerative medicine product as a business and selling it in Japan, the first step is to obtain a manufacturing and sales license for the importer.  Second, a foreign manufacturer’s approval is required for each manufacturing site for those who manufacture in a foreign country.  Third, if there is a business operator in Japan that manufactures label replacements a manufacturing license is required for that business operator.  Fourth, manufacturers and sellers of regenerative medical products need to obtain approval for each item.  Fifth, manufacturers and sellers are required to submit notifications and make public the information contained in the attached documents.

2 Imports other than for business purposes

Import verification is required for imports other than for business purposes.  However, import confirmation is not required for imports of products with a monthly supply or less in terms of dosage, administration, and usage. You can find more information on the Ministry of Health, Labour and Welfare website.

3 Prohibition of Importation

Importation of illicit regenerative medical products, etc. is prohibited.

4 Prohibition of advertisement

It is illegal for an overseas distributor to advertise unapproved regenerative medicine products on sales websites, targeting also those in Japan.  In many cases, advertising by import agents is also illegal.

Please contact us if you have any questions.

Regulations on Importing Cosmetics

The processes for importing cosmetics into Japan differs depending on if the  import is for business purposes or not.

1 Imports for business purposes

When importing cosmetics as a business and selling them in Japan, the process is as follows:

  1. The business operator conducting the importation needs a manufacturing and sales license.
  2. For those who intend to manufacture pharmaceuticals and quasi-drugs imported into Japan from foreign countries, a foreign manufacturer’s authorization is required for each manufacturing site.
  3. Certification as a foreign manufacturer is required for those who intend to manufacture cosmetics to be imported into Japan from abroad.
  4. If there is a business operator that manufactures label replacement, in Japan, a manufacturing license is required.
  5. While approval is required for the manufacture and sale of cosmetics containing undisclosed ingredients on a product-by-product basis, notification of manufacture and sale is required for cosmetics that do not contain such ingredients on a product-by-product basis.
  6. Manufacturers and sellers are required to notify and publicize the information contained in the attached documents. 

2 Imports for non-business purposes

Import confirmation is required for imports for non-business purposes.  However, import verification is not required for up to 24 units (120 units for cosmetics weighing 60 grams or less per unit or 60 ml or less per unit). You can find more information on the Ministry of Health, Labour and Welfare website.

3 Prohibition of imports

The import of illicit cosmetics is prohibited.

 

Please contact us if you have any questions. 

Imported Goods and Domestic Consumption Tax

Section 1:  What is Domestic Consumption Tax?

Foreign goods taken over from bonded areas, so-called “imported goods”, are in principle subject to domestic consumption tax, and the individual who takes over the imported goods is obliged to pay domestic consumption tax. If you are an importer, it is necessary for you to file a domestic consumption tax return and pay it. 

Domestic consumption tax refers to consumption tax, liquor tax, tobacco tax, gasoline tax, local gasoline tax, oil and gas tax, or petroleum and coal tax (See Article 2, Item 1 of the Act on Collection, etc. of Domestic Consumption Tax on Imported Goods).

 

Section 2: When does Domestic Consumption Tax not apply?                            

For the time being, no domestic consumption tax is imposed on goods to which the simplified tax rate for imported goods by entrants is applied (Article 2-2 of the same law). In addition, when customs duties are exempt, it is not uncommon for import consumption tax to also be exempt (Article 13 of the same law); however, it should be noted that there are cases where import consumption tax is not exempt.

It should be noted that even in cases where the tariff rate is zero and therefore no duty is payable, there are cases where import consumption tax must be paid.

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Please contact us if you have any questions.

Companies Act

In cases where a foreign company imports goods from a foreign country to Japan and sells goods to a customer in Japan, the Companies Act may become an issue.

The Companies Act stipulates that “a foreign company shall appoint a representative in Japan if it intends to continue to conduct business in Japan” (Article 817, Paragraph 1 of the Companies Act).  Therefore, for example, if a foreign company wants to open up a bank account in Japan, it will be necessary to have at least a branch office and a registered representative in Japan. In addition, when importing home appliances into Japan, notification is required. However, in the case of foreign corporations not registered in Japan, imports of home appliances into Japan will not be permitted.

In addition, the Companies Act stipulates that “a foreign company whose main purpose is to conduct business in Japan may not continuously conduct business in Japan” (Article 821, Paragraph 1 of the Companies Act), and any violation of this provision shall be subject to a fine (Article 979, Paragraph 2 of the Companies Act).

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Please contact us if you have any questions.

Unfair Competition Prevention Law

Unfair Competition Prevention Law

 Based on the Unfair Competition Prevention Law, the importation of the following products is illegal and is subject to injunctions and claims for damages (Article 2, 3, 4, 16 of the same law). 

(1) Merchandise bearing a foreign flag, emblem or a trademark similar thereto, which has not been approved by a foreign government agency.

(2) A product indication that is the same as or similar to a well-known product indication of another product or business. [e.g., a bag with a logo imitating Chanel, the original plate of a counterfeit credit card with a logo of Visa, MasterCard].

(3) Merchandise that uses the same or similar product indication as that of a well-known other company as its own product indication

(4) Goods that imitate the form of another’s goods (excluding the form essential for securing the function of said goods) [So-called dead copy products, etc.]

(5) Items resulting from the unauthorized use of trade secrets

(6) Devices that illegally circumvent technical restriction measures [unprotected devices].

(7) Products that are misleadingly labeled as to origin, quality, content, manufacturing method, or use.

For example, counterfeit brand-name products like (2) and (3), imitations of other companies’ products (dead copy products), and original plates of counterfeit credit cards with logos like Visa, MasterCard, etc. are illegal.

 

When parallel import of genuine products becomes illegal

 Recently, the popularity of resale business (sedori) has increased, and there have been cases of people being sued for trademark infringement or violation of the Unfair Competition Prevention Law when they purchase authentic products overseas and sell them in Japan.

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Please contact us if you have any questions.

Other Related Laws (Specified Commercial Transactions Law)

Specified Commercial Transactions Law

 The Act on Specified Commercial Transactions is often a problem for foreign companies selling products to Japanese customers through Internet shopping.

The Special Commercial Code regulates the following types of transactions:

  • Door-to-Door Sales
  • Telemarketing Sales
  • Multilevel Marketing
  • Business Opportunity Sales
  • Specified Continuous Services
  • Mail Order Sales

If the product falls under the mail-order sales, product must be labeled in accordance with the Special Commercial Code. Further, if the terms and conditions for returning are not clearly stated, customers may be able to cancel and return the product (See Article 15-2 of the same law).

 

Other

 In addition to the above, various laws and regulations may come into play, such as the Secondhand Articles Dealer Act if you are selling used goods, or the Act against Unjustifiable Premiums and Misleading Representations if you are selling directly to consumers.

 

Please contact us if you have any questions.

Importing and Prohibited Items

There are items that are prohibited from being imported. This article covers stolen cultural property and counterfeit/imitation products which fall under this category.

 

Stolen Cultural Property

 Importing stolen cultural properties is effectively prohibited under the Law on the Prohibition of Illegal Import and Export of Cultural Properties1. In other words, although the Law requires that specified foreign cultural property2 be approved for import under the Foreign Exchange and Foreign Trade Law (Article 4 of the Act on the Prohibition of Illegal Import and Export of Cultural Property, etc.), since property is stolen, it will not be approved and will be returned to the rightful owner3.

Counterfeit and Imitation Products

 Importation of counterfeit or imitation products such as coins, stamps, and postage stamps are prohibited.

 

Import Restrictions

Terms

Act on Control of Imitation of Revenue Stamps

(i) items that have a confusing appearance of government-issued stamps (imitation stamps)4

(ii) items that have a confusing appearance of tax stamp5 impressions

(iii) devices that may produce impressions that have a confusing appearance of tax stamps

 

Import is prohibited without a permit (Law 1 article). An import permit issued by the Minister of Finance. 

[tax stamp]

Act on Control of Imitation, of Postal Stamps

Items that have a confusing appearance as postage stamps or other postage related vouchers.

 

 

Import is prohibited (Article 1 of the Law). Import is exceptionally allowed with the permission of the Minister of Internal Affairs and Communications, but permission is usually not expected.

Criminal law

Counterfeit or altered coins, paper money or banknotes

Import is prohibited (Article 148 of the Law). 

Counterfeit or altered foreign coins, paper money or banknotes

Importation for the purpose of enforcement is prohibited.

1 The official name of the law is the “Law Concerning the Control of Illegal Import and Export of Cultural Properties”.
2 The term “designated foreign cultural property” refers to cultural property designated by the Minister of Education, Culture, Sports, Science and Technology as cultural property when notification is received from a foreign country that cultural property has been stolen in accordance with Article 7 of the Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property. Specified Foreign Cultural Properties are introduced on the website of the Agency for Cultural Affairs.
3 If the importer (or the client) is a bona fide acquirer, the victim is to recover the cultural property after compensation (Article 6 of the Law).
4 Refer to Article 128 of the Basic Circular on the Stamp Tax Law for the criteria for determining whether or not imitation stamps are used.
5 A “tax stamp” is a seal stamped on a certificate or ledger to certify that the tax has been paid when the taxpayer has paid the amount equivalent to the stamp tax in cash instead of affixing a stamp. It is stamped with a tax stamp stamping machine.


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