Regulations on Exporting Pharmaceuticals

Section 1: Pharmaceuticals for Export and Application of the Pharmaceutical Affairs Law

The Pharmaceutical Affairs Law applies to manufacture, sale, production, and marketing of pharmaceuticals in Japan.

In the case of exporting pharmaceutical products, certain exemptions are allowed (Article 74 of the Regulations). This is because some obligations such as descriptions on containers being in Japanese (Article 50) are unreasonable).

In this way, although it provides certain exemptions (Article 74, Paragraph 2), the Pharmaceutical Affairs Law applies to most cases.

For example, even if a Japanese pharmaceutical manufacturer only manufactures pharmaceutical products for export, it is not exempted from licensing as a manufacturer and seller.

In addition, where a pharmaceutical product is purchased from a domestic pharmaceutical manufacturer, distributed wholesale to a trading company, and the trading company exports the pharmaceutical product, it is understood that the business operator in question is required to obtain a wholesale distributor’s license, even if it only handles pharmaceutical products for export.

Section 2: Terminology (Difference between “Manufacture” and “Sale and Manufacture”)

To explain the terminology, “manufacture and sale” means something like placing a product on the Japanese market, and the term refers to both cases where a manufacturer (maker) places a product on the Japanese market and cases where an importer places a product on the Japanese market by importing it from a foreign country. For this reason, importers of pharmaceuticals, etc., need to pay attention to the regulations pertaining to manufacturing and sales under the Pharmaceutical Affairs Law.

On the other hand, when the term “manufacture” is used simply, it is assumed to refer to the actual physical production of the product.

Since the two concepts are distinct, if a pharmaceutical manufacturer (with a manufacturing and sales license) outsources the entire actual manufacturing process to a manufacturer (with a manufacturing license), it will be able to manufacture and sell the product even if it does not have a manufacturing license.

Section 3: Manufacture and Import of Pharmaceuticals for Export

Any person who intends to manufacture (including having a contractor manufacture) or import (including having a contractor manufacture) pharmaceutical products, quasi-drugs, cosmetics, medical devices, or regenerative medicine products for the purpose of export shall notify the Minister of Health, Labor and Welfare (Articles 74, 74-2, and 74-3 of the Pharmaceutical Affairs Law). For export medicines, special exceptions such as exemption from the obligation to label in Japanese are allowed, so notification is required, and the system is designed to enable supervision.

For example, when changes or translations of package designs, instruction manuals, etc. are made in Japan for export, the business operator who performs such work is required to submit a notification as a manufacturer of pharmaceutical products for export (Article 14-9, 14-10, 23-2-12 of the Act, Article 74, 74-2, 74-3 of the Enforcement Order, Article 265 of the Regulations, etc.).

Section 4: Certification of Manufacturers in Japan

A manufacturer of a pharmaceutical product, quasi-drug, medical device, or regenerative medicine product for export shall be certified by the Minister of Health, Labor and Welfare at the time of commencement of production and every five years if the manufacturer is required by a foreign government or international organization to certify that the manufacturing or quality control methods at the manufacturing site of the pharmaceutical product conform to the “Ministerial Ordinance on Standards for Manufacturing and Quality Control of Pharmaceuticals and Quasi-drugs” (GMP Ministerial Ordinance). (Article 80, paragraphs 1 to 3 of the Law, Article 70-2, Article 71, and Articles 73-2 to 73-5 of the Regulations).

The procedures for issuing certificates are handled by the Pharmaceuticals and Medical Devices Agency (PMDA) for pharmaceuticals and quasi-drugs, the Japan Cosmetic Industry Association (JCiA) for cosmetics, and the Overseas Medical Equipment Technical Assistance Association (OMETA) for medical devices, in vitro diagnostic products, and regenerative medical products.

Section 5: Recall

 (1) When a manufacturer of a drug, quasi-drug, cosmetic, medical device, or medical device for regenerative medicine, etc. for export recalls a drug, quasi-drug, cosmetic, medical device, or medical device for regenerative medicine, etc. that it has manufactured, sold, produced, or has obtained approval for, the manufacturer shall report to the Minister of Health, Labor and Welfare that it has initiated the recall and the status of the recall (Article 68-11).

 

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