Importing Drugs (Pharmaceutical Affairs Law)

 This article briefly explains the Pharmaceutical Affairs Law which regulates “manufacture and sale,” “production,” “marketing,” and “advertising” of pharmaceuticals, quasi-drugs, medical devices, and cosmetics. 

Pharmaceuticals and Quasi-drugs

1 Importation as a Business

 In the case of importing pharmaceuticals and quasi-drugs as a business and selling them in Japan, first of all, the business operator conducting the importation is required to obtain a manufacturing and sales license.  Second, those who intend to manufacture pharmaceuticals and quasi-drugs imported into Japan from foreign countries need to be certified as foreign manufacturers for each manufacturing site.  Third, if there is a business operator who manufactures label replacement for Japanese text labeling in Japan, a manufacturing license is required for the business operator who replaces the label.  Fourth, it is necessary to obtain approval for the drug or quasi-drug itself.  However, drugs and quasi-drugs that are designated by the Minister of Health, Labor and Welfare based on established standards do not require approval, but instead require notification of manufacture and sale.  Fifth, manufacturers and sellers are required to submit notifications and publicize the information contained in the attached documents.

2 Imports other than for business purposes

In cases such as (1) importation for personal use, (2) personal importation by a physician or dentist for treatment, and (3) importation for use in clinical trials conducted primarily by a physician or dentist, importation of drugs is possible without approval. In such cases, import verification is required.  However, importation for personal use of: ①(i) topical medicines in quantities of 24 or less; (ii) poisonous, deleterious, or prescription medicines in quantities of 1 month; and (iii) other medicines in quantities of 2 months and ②(i) quasi-drugs in topical form not exceeding 24 units, and (ii) quasi-drugs not exceeding 2 months’ supply, does not require Import verification as well. 

3 Prohibition of Importation

The importation of defective drugs and quasi-drugs is prohibited, whether as a business or personal import. 

4 Prohibition of Advertising

It is illegal for foreign distributors to advertise unapproved/unauthenticated drugs on drug sales websites, even to those in Japan.  In many cases, advertising by import agents is also illegal.

 

2 Cosmetics

1 Importation as a Business

When importing cosmetics as a business and selling them in Japan, first, the business operator conducting the importation needs a manufacturing and sales license.  Second, 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.  Third, certification as a foreign manufacturer is required for those who intend to manufacture cosmetics to be imported into Japan from abroad.  Fourth, if there is a business operator that manufactures label replacement, in Japan, a manufacturing license is required.  Fifth, 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.  Sixth, 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). 

3 Prohibition of import

The import of illicit cosmetics is prohibited.

 

3 Medical Devices and In Vitro Diagnostic Products

1 Import 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. 

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. 

 

4 Regenerative Medical and Other Products

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.

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.

 

5 Veterinary Drugs

1 Basic Concept

For veterinary medicinal products, the provisions for conventional medicinal products, quasi-drugs, medical devices and medical products for regenerative medicine are applied the same as the explanation for each category above.  However, unlike pharmaceuticals, the Ministry of Health, Labor and Welfare does not have jurisdiction over this issue, but rather the Ministry of Agriculture, Forestry and Fisheries does. 

2 Importation as a Business

In the case of importing veterinary medicinal products as a business, first, the importer is required to obtain a license from the Minister of Agriculture, Forestry and Fisheries for manufacturing and sales.  Second, for those who manufacture veterinary medicinal products in a foreign country, certification and registration as a foreign manufacturer is required for each manufacturing site.  Third, business operator in Japan that manufactures label replacements, that operator will need to obtain a manufacturing license and registration. Fourth, for veterinary drugs to be imported, approval and certification are required for each product.

3 Import for 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. 

4 Prohibition of importation

Import of illicit veterinary drugs is prohibited.

5 Prohibition of Advertising

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

 

6 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 “List of Designated Drugs” 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”(合法ドラッグ) 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. 

Poppyseed

A permit is required for importation.

Please contact us if you have any questions.