How to Obtain a Drug Import Permit (Yakkan Shomei): A Comprehensive Guide to Procedures and Precautions for Personal Import | TASAKI PHAMA

What is a Yakkan Shoumei? Necessity for Personal Imports

A Yakkan Shoumei (Import Certificate for Pharmaceuticals, etc.) is a document that certifies that an individual meets the requirements set by the Ministry of Health, Labour and Welfare when importing pharmaceuticals, quasi-pharmaceutical products, or cosmetics from overseas. Without this certificate, customs may withhold the import. In particular, even for personal use, a Yakkan Shoumei is often required when importing unapproved pharmaceuticals.

Personal import is used as a means to easily obtain overseas pharmaceuticals, but caution is required because there are products whose safety and quality are not guaranteed. The Yakkan Shoumei is an important procedure to reduce these risks and promote the appropriate use of pharmaceuticals.

Cases Requiring a Yakkan Shoumei

• When importing pharmaceuticals for personal use
• When transferring pharmaceuticals purchased overseas to an acquaintance
• When selling or giving overseas pharmaceuticals in Japan (permission required)

For example, if you personally import certain anti-cancer drugs approved overseas (e.g., Pembrolizumab, Nivolumab), a Yakkan Shoumei is required. These drugs are also approved in Japan, but when importing them personally, it is necessary to have appropriate documents such as a doctor’s diagnosis and prescription.

How to Obtain a Yakkan Shoumei: Application Process and Required Documents

Obtaining a Yakkan Shoumei can be done through the following process. In principle, the importer must apply, but it can also be done by experts such as administrative scriveners.

Application Process

1. Preparation of Required Documents: Doctor’s diagnosis/prescription, product information (ingredients, content, manufacturing method, etc.), import plan, etc.
2. Preparation of Application Form: Download the application form from the Ministry of Health, Labour and Welfare website and fill in the necessary information
3. Application: Submit the necessary documents and application form to the competent Local Health Bureau (by mail or in person)
4. Examination: Document examination by the Local Health Bureau
5. Issuance of Yakkan Shoumei: The Yakkan Shoumei will be issued after passing the examination

Main Required Documents

• Application Form for Import Confirmation of Pharmaceuticals, etc.: Designated form of the Ministry of Health, Labour and Welfare
• Doctor’s Diagnosis/Prescription: Must include the name of the disease, drug name, dosage, etc.
• Product Information: Ingredients, content, manufacturing method, information on the manufacturer, etc.
• Copy of Identification: Driver’s license, passport, etc.
• Import Plan: Description of import purpose, quantity, frequency, etc.

Preparing the application documents is complicated, and if there are deficiencies, the examination may take time. For example, if information on the ingredients of overseas pharmaceuticals is insufficient, additional information gathering may be required, such as contacting the manufacturer.

Detailed information and Q&A regarding the application are available on the Ministry of Health, Labour and Welfare website, so please refer to it. (Reference: Ministry of Health, Labour and Welfare “About Personal Import of Pharmaceuticals, etc.”)

Points to Note and Frequently Asked Questions Regarding Yakkan Shoumei Acquisition

There are several points to note when acquiring a Yakkan Shoumei. We will also explain frequently asked questions from applicants.

Points to Note

• False Applications are Strictly Prohibited: Applying with false information may result in legal penalties.
• Pharmaceuticals with Import Restrictions: There are pharmaceuticals that are not approved in Japan, or narcotics or psychotropic drugs, that are prohibited or restricted from import.
• Scope of Personal Use: The quantity that can be imported is, in principle, limited to the scope of personal use.

Frequently Asked Questions

Q. Is it possible to have someone apply for the Yakkan Shoumei on my behalf?

A. Yes, it is possible to have an expert such as an administrative scrivener apply on your behalf. However, there will be a fee for the service.

Q. Is there an expiration date for the Yakkan Shoumei?

A. Yes, the Yakkan Shoumei has an expiration date. It is usually valid for one year from the date of issue.

Q. Are there cases where a Yakkan Shoumei is not required?

A. As an exception, a Yakkan Shoumei may not be required when a doctor imports for treatment purposes or when overseas travelers bring pharmaceuticals as personal belongings.

Applying for a Yakkan Shoumei can be done individually, but because specialized knowledge and procedures are required, it is recommended to consider consulting with an expert if you are unsure.

Future Prospects for Yakkan Shoumei and Personal Imports

The Yakkan Shoumei is an important system for ensuring the safety of pharmaceuticals, etc., that are personally imported. In recent years, the demand for personal imports has been increasing as it has become easier to obtain overseas pharmaceuticals through the Internet. However, on the other hand, the risk of counterfeit or poor-quality products is also increasing.

The Ministry of Health, Labour and Welfare is strengthening its efforts to reduce these risks and protect the health of the public through the Yakkan Shoumei system. In the future, improvements in the system are expected, such as online application procedures for the Yakkan Shoumei and strengthening of the examination system.

In addition, regulations regarding the personal import of pharmaceuticals differ in each country. For example, in the United States, the FDA (Food and Drug Administration) has regulations regarding the import of pharmaceuticals, and in the EU, the EMA (European Medicines Agency) approves and monitors the safety of pharmaceuticals. It is hoped that Japan’s Yakkan Shoumei system will also evolve into a more effective and efficient one, referring to these regulations.

Personal import can be a means for patients to obtain necessary pharmaceuticals, but it is important to fully understand the risks regarding safety and quality and make judgments based on appropriate information. It is also important to consult with experts such as doctors and pharmacists and receive appropriate advice.

Summary

The Yakkan Shoumei is a necessary procedure when an individual imports pharmaceuticals from overseas, and it plays an important role in ensuring safety and quality. The application requires various documents such as a doctor’s diagnosis and product information, and the procedure is complicated. In the future, it is expected that safer and more efficient personal import of pharmaceuticals will be realized through system improvements and international cooperation. When engaging in personal import, it is important to fully understand the risks and seek expert advice.