Quasi-Drugs under the PMD Act

Overview

Quasi-drugs are products regulated under the PMD Act that have milder effects on the human body than pharmaceuticals but are used for certain specified purposes. In practice, many products marketed in Japan as “medicated” products fall into this category.

For import practice, the key issue is whether an overseas product can be treated as a cosmetic or general consumer product in Japan, or whether it falls within the quasi-drug category. The product’s appearance or overseas classification is not enough. Ingredients, intended use, efficacy claims, labeling, advertising and sales purpose must be checked.

Difference from Cosmetics

Cosmetics are generally intended to clean, beautify, increase attractiveness, change appearance or keep the skin or hair in good condition, with mild effects on the human body. Quasi-drugs, by contrast, are used for certain approved effects such as preventing heat rash, skin irritation, body odor or hair loss, or promoting hair growth, depending on the product category.

The same type of skincare, haircare or oral care product may be treated differently depending on its ingredients and claims. A product used only for ordinary beauty or hygiene purposes may be a cosmetic, while a product marketed with “medicated” effects may need to be treated as a quasi-drug.

Products Where This Issue Often Arises

Quasi-drug issues often arise in beauty, hygiene, haircare, oral care and body care products. Products that emphasize specific effects should be checked carefully before shipment or sale in Japan.

• Medicated toothpaste
• Medicated shampoo
• Hair growth products and hair removal products
• Antiperspirants and deodorant products
• Bath preparations
• Whitening or brightening skincare products marketed with quasi-drug effects
• Products claiming to prevent rough skin, acne, heat rash or similar conditions

Main Points to Check

• Is the product intended to be sold as a cosmetic, quasi-drug or general good in Japan?
• Does the product use “medicated” or similar wording?
• Does it claim effects such as whitening, hair growth, hair removal, sterilization, deodorization or prevention of skin trouble?
• Are the ingredients permitted for the intended product category in Japan?
• Are the claimed effects within the permitted scope for quasi-drugs?
• Is product-level approval required before sale in Japan?
• Is a Japan-side Marketing Authorization Holder involved?
• Has the importer checked Japanese labeling and advertising before sale?

Import and Sale in Japan

Quasi-drugs cannot be handled in the same way as ordinary miscellaneous goods or simple cosmetic imports. When quasi-drugs are imported for commercial sale in Japan, the Japan-side regulatory structure must be checked before market placement.

Unlike cosmetics, quasi-drugs generally require product-level approval before they can be placed on the Japanese market. This approval is separate from the marketing authorization holder licence and must be obtained for each product.

Depending on the product and business model, this may involve a quasi-drug marketing authorization holder licence, manufacturing establishment registration, product-level approval and other PMD Act procedures. If storage, labeling, packaging, relabeling or other regulated operations are carried out in Japan, the need for manufacturing registration should also be checked.

Overseas suppliers should understand that the Japanese importer or Japan-side Marketing Authorization Holder usually handles the regulatory procedure. However, overseas product descriptions, ingredient information, labels, catalogues and advertising materials can still affect the Japanese assessment.

Personal Import and Business Import

Personal import and business import should be distinguished. A product brought into Japan for an individual’s own use is different from a product imported for sale, resale, EC distribution, advertising, demonstration or business use.

However, personal import does not automatically remove all concerns. If the product is later sold, advertised, distributed or promoted in Japan, the Japanese labeling, product category and advertising claims may become PMD Act issues. For business import, the quasi-drug status should be checked before shipment or before sales pages are published.

Common Problems

• An overseas product is treated as a cosmetic abroad, but its Japanese claims suggest quasi-drug effects.
• The importer assumes that a “medicated” personal care product can be imported as an ordinary cosmetic.
• Whitening, hair growth, hair removal, sterilization, deodorization or acne-prevention claims are used without checking the product category.
• Overseas marketing copy is translated directly into Japanese and creates excessive efficacy claims.
• The product is shipped before product-level approval or Japan-side regulatory responsibility has been confirmed.
• Labels, manuals, EC pages or social media content go beyond the permitted scope of claims.

Practical Notes for Shipments to Japan

For shipments to Japan, overseas suppliers and origin-side forwarders should not decide the category based only on the product name, invoice description or overseas sales category. A “cosmetic,” “personal care product,” “deodorant,” “shampoo,” “toothpaste” or “whitening product” may require quasi-drug confirmation depending on its ingredients and claims.

This is especially important for products labeled or marketed as “medicated.” In Japan, “medicated” wording is not just a marketing expression. It may indicate that the product is expected to be handled within the quasi-drug framework.

Before shipment, the Japanese importer should confirm whether the product can be sold as a cosmetic, whether it must be treated as a quasi-drug, and whether the necessary licence, registration, product approval and labeling review have been completed.

Relationship with Logistics and Customs

Forwarders and customs brokers are not expected to make final PMD Act classification decisions. However, they should notice warning signs when cargo is described as a medicated product, deodorant, hair growth product, hair removal product, whitening product, medicated toothpaste, medicated shampoo or similar item.

For logistics practice, this is partly a document-control issue. The invoice, packing list, product label, ingredient list, brochure, manual and EC page should not create conflicting impressions. If shipping documents describe the product as a cosmetic but sales materials emphasize quasi-drug-like effects, the importer should be asked to confirm the regulatory position.

The issue may also arise after customs clearance. A product may physically arrive in Japan, but domestic sale may be delayed or stopped if the quasi-drug status, product approval, labeling or advertising claims have not been checked.

Labeling and Advertising Claims

For quasi-drugs, efficacy claims must remain within the approved or permitted scope. Product labels, EC pages, brochures, advertisements, social media posts and sales materials should be reviewed carefully before sale in Japan.

Claims that go beyond prevention, hygiene or the approved quasi-drug scope may be treated as medicinal or pharmaceutical-style claims. For example, expressions suggesting treatment, cure or improvement of disease may create problems under the PMD Act.

Where advertising creates a misleading impression about efficacy, the Act against Unjustifiable Premiums and Misleading Representations may also become relevant alongside the PMD Act.

Relationship with Cosmetics and Pharmaceuticals

Quasi-drugs often sit between cosmetics and pharmaceuticals in practical import discussions. They are not ordinary cosmetics, but they also do not usually claim the strong therapeutic effects of pharmaceuticals.

This middle position is exactly why classification mistakes happen. A product that appears to be a cosmetic or daily-use product may require quasi-drug handling if it contains certain active ingredients or claims certain effects. Conversely, if the claims go too far, the issue may move closer to pharmaceutical-style regulation.

Key Takeaway

Quasi-drugs are a key PMD Act category for imported beauty, hygiene, haircare, oral care and body care products. Importers and logistics parties should not rely only on the overseas product category or product name. Ingredients, intended use, “medicated” wording, whitening or other efficacy claims, labeling, advertising, product-level approval and Japan-side regulatory procedures should be checked before shipment and market launch.