Quasi-Drugs — Classification and Import Procedures
Interlink編集部What Are Quasi-Drugs?
Quasi-drugs are products defined under the Pharmaceutical and Medical Device Act (PMD Act) that have milder effects on the human body compared to pharmaceuticals but are intended to provide certain efficacy or benefits.
Common examples include products labeled as "medicated."
However, the mere presence of "medicated" in the product name does not automatically classify it as a quasi-drug. It is necessary to comprehensively assess ingredients, active components, claimed efficacy, intended use, labeling, advertising, and sales methods.
In import logistics, it is important to verify whether foreign-made products can be treated as cosmetics in Japan, qualify as quasi-drugs, or are classified as pharmaceuticals.
Determining this cannot be done solely by product appearance or classification in the country of sale; how efficacy is displayed and how the product is sold within Japan are critical considerations.
Scope Covered in This Article
| Item | Topics Covered in This Article | Topics Covered in Other Articles |
|---|---|---|
| Basics of Quasi-Drugs | Classification under the PMD Act, showing that quasi-drugs have milder effects on the body than pharmaceuticals but aim for certain efficacy or benefits. | The overall regulatory framework of the PMD Act is covered in "What Is the PMD Act?" |
| Differences from Cosmetics and Pharmaceuticals | Clarifies differences in objectives, claims, and approval or authorization between cosmetics, quasi-drugs, and pharmaceuticals. | Definitions, ingredient regulations, and full ingredient listing for cosmetics are covered under "Cosmetics." |
| Relation to Medicated Cosmetics | Discusses products such as medicated whitening products, medicated acne prevention products, medicated shampoos, and medicated toothpaste as quasi-drugs. | Permits and notifications for import and sales of cosmetics are organized under "Cosmetics Import and Sales Permits." |
| Active Ingredients and Efficacy | Outlines key issues regarding active ingredients, formulation amounts, claims, dosage and administration, dosage form, and labeling scope for quasi-drugs. | Judgment criteria for expressions related to treatment, prevention, or improvement of diseases are detailed in "Pharmaceutical-Like Efficacy Claims." |
| Types of Quasi-Drugs | Organizes categories such as medicated cosmetics, specified quasi-drugs, newly specified quasi-drugs, and pest control quasi-drugs. | Approval standards and review materials for individual items require expert confirmation on a case-by-case basis. |
| Procedures for Import and Sales | Covers Manufacturing and Marketing Authorization, manufacturing licenses, Foreign Manufacturer Accreditation, product approval, and verification of labeling and advertising. | Individual application procedures, approval reviews, and permit requirements need confirmation from administrative and pharmaceutical regulatory experts. |
| Freight Forwarder and Customs Practice | Summarizes points freight forwarders should check, document collection, information sharing with customs brokers, and avoidance of definitive statements. | Final judgments about quasi-drug classification, approval, and permit requirements should be confirmed by the importer. |
Purpose and Background of the System
Quasi-drugs are not intended to have the strong therapeutic effects that pharmaceuticals do.
However, because they exert certain effects on the body or aim for specific efficacy, they fall under regulation by the PMD Act.
For quasi-drugs, the scope of approved efficacy, active ingredients, formulation amounts, dosage and administration, dosage form, and labeling methods is crucial.
Even products that appear to be cosmetics may require confirmation as quasi-drugs if they claim medicinal effects.
Overview
Examples of quasi-drugs may include medicated toothpaste, medicated shampoo, medicated hair growth agents, antiperspirants, hair removal agents, bath additives, insect repellents, topical disinfectants, and treatments for prickly heat or rash.
In import practice, even products sold overseas as cosmetics, skin care, hair care, daily care products, or household products may require confirmation as quasi-drugs if medicinal effects are claimed in Japan.
Products labeled with terms such as medicated, anti-acne, anti-dandruff, hair growth, whitening, deodorant, antibacterial, or insect repellent especially need to be checked to determine whether they can be handled as cosmetics or general goods or must be treated as quasi-drugs.
Differences Between Cosmetics, Quasi-Drugs, and Pharmaceuticals
| Category | Main Purpose | Claims and Efficacy | Approach to Approval and Licensing | Notes in Import Practice |
|---|---|---|---|---|
| Cosmetics | Aimed at cleansing, beautifying, enhancing attractiveness, altering appearance, and maintaining skin or hair health. | Claims are limited to those recognized as cosmetic effects. | Issues revolve around cosmetics Manufacturing and Marketing Authorization, manufacturing licenses, and product notifications. | Claiming medicinal effects or therapeutic benefits may exceed the scope of cosmetics. |
| Quasi-Drugs | Have milder effects on the body and target certain specified efficacy. | Scope involves approved efficacy, active ingredients, formulation amounts, and dosage. | Require quasi-drug Manufacturing and Marketing Authorization, manufacturing licenses, Foreign Manufacturer Accreditation, and product approval. | Products claiming medicated, hair growth, deodorizing, antibacterial, or insect repellent effects require confirmation as quasi-drugs. |
| Pharmaceuticals | Intended for diagnosis, treatment, prevention of disease, or affecting body functions. | Claims center on treatment, prevention, and improvement of disease conditions. | Require pharmaceutical approval and Manufacturing and Marketing Authorization. | Products exceeding the scope of quasi-drugs in claims or ingredients may be classified as pharmaceuticals. |
| General Goods / Sundries | Non-regulated products not classified as pharmaceuticals or quasi-drugs under the PMD Act. | Cannot claim medicinal effects, therapeutic benefits, or effects on body functions. | While no approval under the PMD Act is needed, compliance with other laws may be necessary. | Depending on advertising claims, even general goods may require confirmation regarding quasi-drug or pharmaceutical classification. |
Relation to Medicated Cosmetics
Medicated cosmetics generally refer to products that have the appearance of cosmetics but are treated as quasi-drugs containing certain active ingredients and efficacy claims.
Examples include medicated whitening cosmetics, medicated acne prevention products, medicated shampoos, medicated toothpaste, and medicated hair growth products, which are frequently areas of concern.
Even products sold overseas as cosmetics, skin care, or hair care must have approval or authorization as quasi-drugs confirmed if they claim medicated effects in Japan.
Particularly for products labeled with terms such as whitening, anti-acne, medicated, anti-dandruff, hair growth, deodorant, or antibacterial, it is necessary to check whether they can be marketed in Japan with cosmetic-level claims or need to be treated as quasi-drugs.
Main Categories of Quasi-Drugs
| Category | Main Content | Practical Notes | Documents to Verify |
|---|---|---|---|
| Medicated Cosmetics | Includes medicated whitening, medicated acne prevention, medicated shampoos, medicated toothpaste, and similar products. | Even if they look like cosmetics, approval as a quasi-drug may be required. | Active ingredient data, efficacy claims, approval documents, labeling drafts |
| Specified Quasi-Drugs | Quasi-drugs designated by the Minister of Health, Labour and Welfare. | Items transitioned from pharmaceuticals require confirmation of labeling and sales methods. | Item classification, labeling, efficacy claims, sales materials |
| Newly Specified Quasi-Drugs | Certain groups including throat fresheners, external disinfectants, and products for prickly heat and rash. | Approval criteria, efficacy claims, usage instructions, and ingredient range should be confirmed. | Approval criteria, ingredient data, usage instructions, efficacy claim data |
| Pest Control Quasi-Drugs | Products intended for controlling mosquitoes, flies, fleas, and similar pests. | Labeling and precautions vary depending on whether the product is for direct human use or environmental application. | Usage description, active ingredients, target pests, application sites, labeling precautions |
| Other Quasi-Drugs | Includes hair tonics, depilatories, antiperspirants, bath additives, and similar products. | Approval details, active ingredients, and permissible efficacy claims should be confirmed. | Active ingredients, formulation amounts, approval documents, advertising drafts, sales page drafts |
Importers need to verify not only whether a product falls under quasi-drugs but also which specific category of quasi-drug it should be classified as.
Verification of Active Ingredients and Efficacy Claims
For quasi-drugs, the relationship between active ingredients and efficacy claims is crucial.
While cosmetics mainly focus on full ingredient disclosure and cosmetic standards, quasi-drugs require checking the approved active ingredients, their concentrations, efficacy claims, usage instructions, dosage form, and labeling scope.
Even similar products may require quasi-drug approval if they contain active ingredients and claim medicated effects.
| Verification Item | Main Content | Common Causes for Delays | Practical Responses |
|---|---|---|---|
| Active Ingredients | Confirm whether the active ingredients are recognized as quasi-drug active ingredients in Japan. | When ingredients used overseas do not align with Japan’s approved scope. | Check active ingredient names, standards, purpose of inclusion, and approval documents. |
| Concentration | Verify whether the active ingredient concentration complies with the approved range or standards. | Differences in concentration compared to Japan’s standards for the same ingredient. | Check formulation amounts, concentration, specifications, and COA. |
| Efficacy Claims | Check that the displayed efficacy claims fall within the approved scope. | Claims exceeding approved therapeutic or improvement effects. | Compare approved efficacy claims with advertising drafts. |
| Usage Instructions and Dosage | Verify that the usage method, frequency, and target application areas match approved content. | Overseas usage instructions applied without modification for the Japanese market. | Check labels, instructions, usage methods, and target users. |
| Dosage Form and Use | Confirm dosage form and use such as cream, lotion, shampoo, tablet, spray, or similar forms. | Attempts to market in dosage forms incompatible with the item group or approval criteria. | Check dosage form, intended use, approval standards, and sales format. |
In quasi-drugs, terms such as "effective," "medicated," and "prevents" cannot be used freely.
It is fundamental to display only efficacy claims permitted within the approved scope.
Applicable Requirements and Exclusions
| Category | Situations Requiring Confirmation as Quasi-Drug | Situations Often Excluded or Classified Separately | Practical Notes |
|---|---|---|---|
| Medicated Cosmetics | When claiming medicinal effects such as whitening, acne prevention, rough skin prevention, or dandruff and itch prevention. | If limited to cleanliness, beautification, or maintaining healthy skin or hair, it may be classified as a cosmetic. | Check not only the "medicated" label but also active ingredients, efficacy, and approval scope. |
| Hair Growth and Hair Removal Products | When claiming hair growth promotion, prevention of hair loss, or hair removal. | If limited to hair care, styling, or cleansing, it may be classified as cosmetics or sundries. | Confirm not to confuse hair growth promotion with hair regrowth or hair loss treatment. |
| Antiperspirants and Deodorants | When claiming antiperspirant, deodorizing, antibacterial, or body odor prevention effects. | If limited to fragrance or general cleanliness maintenance, it may be classified as cosmetics or sundries. | Confirm active ingredients and scope of claimed effects. |
| Topical Disinfectants and Hand Sanitizers | When claiming bactericidal, disinfection, or infection prevention effects. | If limited to wiping, washing, or general hygiene product descriptions, it may be classified separately. | Check whether the product is a quasi-drug or a pharmaceutical, and confirm usage, dosage, and claimed effects. |
| Insect Repellent and Insecticide Products | When intended for pest control such as mosquitoes, flies, fleas, and similar pests. | If limited to environmental sundries, fragrance, or general household goods, classification may differ due to other laws. | Confirm classification among pest-control quasi-drugs, pharmaceuticals, or sundries. |
| Personal Imports | When importing for domestic sales, resale, or business use. | If limited to personal use, it is classified separately from commercial imports. | Being able to import personally does not mean the goods can be sold domestically. |
| Products with Pharmaceutical Claims | When claiming treatment, improvement, hair growth, disease prevention, or similar effects. | If claims fall within approved quasi-drug efficacy ranges, they are classified accordingly. | Claims exceeding approval scope may raise pharmaceutical classification or advertising regulation issues. |
Main Procedures for Import Sales
When importing and selling quasi-drugs for commercial purposes, they cannot be handled the same as general sundry imports or cosmetics imports.
Depending on the item, quasi-drug Manufacturing and Marketing Authorization, manufacturing licenses, Foreign Manufacturer Accreditation, and individual item approvals may be involved.
The importer cannot simply buy products from an overseas manufacturer and start selling. They need to confirm who is the Marketing Authorization Holder in Japan, where storage, labeling, and packaging will be conducted, whether information from the overseas manufacturer can be obtained, and whether item-specific approvals are in place.
| Check Item | Main Contents | Common Hold-up Reasons | Practical Countermeasures |
|---|---|---|---|
| Quasi-Drug Classification | Confirm whether the product is a cosmetic, quasi-drug, or pharmaceutical. | Relying solely on overseas labeling as cosmetic or daily care product. | Check active ingredients, efficacy, advertising expressions, and sales methods in Japan. |
| Manufacturing and Marketing Authorization | Confirm the Marketing Authorization Holder responsible for market shipment in Japan. | The importer considers itself just a seller and has not designated a Marketing Authorization Holder. | Identify who will act as the Marketing Authorization Holder for market shipment. |
| Manufacturing License | Confirm licensing for locations handling storage, packaging, labeling, and similar operations in Japan. | Failing to check whether licenses are needed for labeling or storage at warehouses. | Confirm domestic facility and scope of operations. |
| Foreign Manufacturer Accreditation | Accreditation and information confirmation for overseas manufacturing sites. | Unable to obtain manufacturing site information or necessary documents from overseas manufacturers. | Confirm the manufacturer’s willingness to cooperate prior to ordering. |
| Item Approval | Confirm approvals for individual items, including active ingredients, efficacy, and usage instructions. | Incorrectly assuming individual products can be sold with only a business authorization. | Check approval documents, scope of approval, label drafts, and advertising materials. |
| Labeling and Advertising | Confirm that labeling and advertising are within the approved efficacy scope. | Using direct translations of overseas ads with expressions exceeding approved scope. | Review Japanese labels, e-commerce pages, social media posts, and advertising texts. |
Application Flow of the System
- For overseas products, confirm the product name, usage, ingredients, active ingredients, labeling in the country of sale, and advertising expressions.
- Organize whether the product may fall under cosmetics, quasi-drugs, pharmaceuticals, or general goods in Japan.
- Check for expressions such as medicated, anti-acne, anti-dandruff, hair growth, whitening, deodorant, antibacterial, insect repellent, and similar wording.
- If the product may be classified as a quasi-drug, verify the active ingredients, dosage, efficacy, usage instructions, and formulation.
- Check whether item-by-item approval is required or whether approval has already been obtained.
- Confirm the Marketing Authorization Holder within Japan for domestic market shipment.
- Confirm whether a manufacturing license is required for locations handling storage, packaging, labeling, or label application within Japan.
- For overseas manufacturing sites, confirm whether Foreign Manufacturer Accreditation is necessary.
- Prepare copies of permits, approval documents, ingredient lists, efficacy explanations, and usage explanations required for customs clearance.
- Before market shipment, the Marketing Authorization Holder should verify quality, labeling, and approval content.
- Before sales launch, check that e-commerce pages, advertisements, social media posts, brochures, landing pages, and video explanations are consistent with the approved scope.
Import Handling Workflow
| Stage | Main Points to Confirm | Common Reasons for Delays |
|---|---|---|
| Before Procurement | Confirm product usage, ingredients, efficacy, labeling in country of sale, and advertising expressions. | Assuming the product is classified the same in Japan because it is sold as a general product overseas. |
| Classification Confirmation | Confirm whether it falls under cosmetics, quasi-drugs, or pharmaceuticals. | Overlooking labeling such as "medicated" or "anti-acne." |
| Authorization and Approval Confirmation | Confirm Manufacturing and Marketing Authorization, manufacturing license, Foreign Manufacturer Accreditation, and item approval. | Advancing import arrangements before item approval or active ingredient confirmation is completed. |
| Import Arrangement | Organize necessary permit copies, approval documents, and product data for customs clearance. | Finding out about missing documents just before customs clearance. |
| Domestic Storage and Labeling | Confirm labels, markings, packaging, storage locations, and manufacturing licenses. | Failing to confirm the permit category when applying Japanese labels at the warehouse. |
| Market Shipment Decision | The Marketing Authorization Holder confirms quality, labeling, and approval content to decide on market shipment. | Misunderstanding that customs clearance automatically means sales are allowed. |
| Before Sales Launch | Confirm efficacy expressions used on e-commerce pages, advertisements, social media posts, and brochures. | Using advertising expressions that exceed approved efficacy claims. |
Products Commonly Causing Issues in Import Handling
Products that may correspond to quasi-drugs are often found among beauty, hygiene, hair care, oral care, deodorant, and insect repellent products.
- Medicated toothpaste
- Medicated shampoo
- Medicated lotions, medicated creams, medicated serums
- Products claiming whitening, acne prevention, or rough skin prevention
- Hair growth agents, hair removal products
- Antiperspirants, deodorant products
- Bath additives
- External skin disinfectants, hand disinfectants
- Insecticides, insect repellents, insect protection products
- Products claiming to prevent heat rash, chafing, cracks, or chilblains
Even if these products are sold overseas as cosmetics, daily necessities, sundries, or supplements, they may qualify as quasi-drugs or pharmaceuticals in Japan depending on the efficacy claims.
Cases Often Causing Issues in Practice
| Case | Common Issues | Documents to Verify | Practical Considerations |
|---|---|---|---|
| Importing overseas medicated cosmetics as cosmetics | Expressions such as medicated, anti-acne, and whitening can raise questions about whether the product qualifies as a quasi-drug. | Overseas advertisements, ingredient lists, active ingredient documentation, proposed Japanese labels, draft sales pages | Limit descriptions to those allowed for cosmetics or confirm quasi-drug approval. |
| Exceeding the approved efficacy range for medicated shampoo | May claim to treat scalp inflammation or promote hair growth beyond dandruff and itch prevention. | Approval documents, active ingredients, claimed efficacy, advertising drafts, product descriptions | Compare approved efficacy with the advertising statements. |
| Using hair growth or treatment claims for hair tonics | Hair growth promotion, hair regrowth, hair loss treatment, and thinning hair treatment are easily confused. | Active ingredients, quantities, approval documentation, advertising drafts, social media post drafts | Check whether claims exceed the quasi-drug range into medicinal efficacy. |
| Misclassification of insect repellent and insecticide products | Distinguishing between quasi-drugs for pest control, pharmaceuticals, or general goods can cause issues. | Active ingredients, target pests, usage descriptions, application locations, label drafts | Confirm whether the product is intended for direct human use or environmental use, and verify target pests and efficacy. |
| Unclear Marketing Authorization Holder and product approval status | Uncertainty about who holds market shipment responsibility and whether product approval exists. | Manufacturing and Marketing Authorization documents, approval documents, outsourcing contracts, manufacturing license documents | Clarify the responsible party, approvals, and domestic operation sites before import. |
| Applying Japanese labels at domestic warehouses | Manufacturing licenses may be involved in storage, packaging, labeling, and label application. | Warehouse information, work content, manufacturing license, outsourcing contract | Separate logistics work from manufacturing acts under the PMD Act. |
| Directly translating overseas advertisements | May retain efficacy claims or medicinal expressions beyond the approved scope. | Overseas advertisements, Japanese ad drafts, landing pages, social media drafts, video scripts | Revise advertisements for the Japanese market to stay within approved scope. |
| Selling personal import items domestically | Confusion between personal-use import and commercial import for sales. | Purchase history, quantities, sales page, delivery destination, sales plan | Confirm quasi-drug status, approval, permits, labeling, and advertising when selling domestically. |
Advertising and Labeling Considerations
For quasi-drugs, displaying efficacy claims beyond the approved scope is not permitted.
If claims extend to disease treatment or improvement beyond approved efficacy, it may raise issues as medicinal efficacy claims.
For example, medicated cosmetics may be labeled as "prevents acne," but expressions such as "treats acne," "cures skin diseases," or "improves inflammation" might be problematic.
Even if certain expressions are allowed for medicated hair tonics, claims such as "promotes hair growth," "treats thinning hair," or "medically stimulates hair growth" could exceed the approved range.
Verification should include product labels as well as e-commerce pages, brochures, social media posts, advertisements, landing pages, video explanations, sales pages, and quoted customer reviews.
Differences Between Personal Import and Commercial Import
Even for quasi-drugs, personal use imports and imports for commercial sales should be handled separately.
Requirements differ depending on whether the product is purchased overseas for personal use or imported for sale, resale, distribution, or business use within Japan.
Quasi-drugs, hair tonics, hair removal agents, disinfectants, insect repellents, and related items obtained through personal import cannot be sold domestically.
For commercial import and sale, issues arise concerning quasi-drug classification, Manufacturing and Marketing Authorization, manufacturing licenses, Foreign Manufacturer Accreditation, product approval, and labeling and advertising compliance.
Points to Check in Forwarding and Customs Practices
Freight forwarders and customs personnel should not judge whether a product is a quasi-drug based solely on the cargo name but must confirm the product's use, ingredients, sales purpose, and planned labeling with the importer.
Forwarders are not responsible for making the final determination on quasi-drug classification or the need for permissions and approvals.
However, if the cargo name, product description, sales materials, or advertising suggest the product might qualify as a quasi-drug, it is necessary to urge the importer to confirm and share this information with customs brokers promptly.
If customs conduct verification, the forwarder should collect product catalogs, ingredient lists, active ingredient documentation, efficacy explanations, approval documents, copies of permits, usage explanations, and draft sales pages from the importer, and coordinate with customs brokers.
Forwarders should avoid making definitive statements such as "No problem because it does not say 'medicated,'" "Can be imported as cosmetics," or "It is not a quasi-drug."
Scope of Forwarder Involvement
| Category | What Can Be Supported | What Should Not Be Concluded | Practical Measures |
|---|---|---|---|
| Products labeled as medicated | Forwarders can encourage importers to confirm ingredients, active ingredients, efficacy, and advertising expressions. | Do not conclude that it is acceptable because it is not labeled as medicated, or that it can be sold because it is medicated. | Encourage confirmation of regulatory check results, approval documentation, and labeling drafts. |
| Products planned for import as cosmetics | Forwarders can encourage confirmation of whether there are any medicated effects or pharmaceutical-type expressions in the sales page draft. | Do not conclude that the product can be imported as a cosmetic or that it is not a quasi-drug. | Request the importer to confirm the boundary between cosmetics and quasi-drugs. |
| Hair growth, hair removal, deodorant, and anti-odor products | Forwarders can encourage confirmation of uses, active ingredients, efficacy, and approval documentation. | Do not conclude that the product can be treated as general goods or cosmetics. | Encourage confirmation of whether it qualifies as a quasi-drug and the scope of approval. |
| Pest control and insecticide-related products | Forwarders can support collecting information on target pests, usage locations, whether it is used on humans, and ingredient data. | Do not conclude that household products are not subject to the PMD Act. | Encourage confirming classification as a quasi-drug for pest control, pharmaceutical, or general goods. |
| When customs inquiries occur | Forwarders can collect product catalogs, ingredient lists, active ingredient documentation, approval materials, and copies of permits. | Freight forwarders should not make final decisions on import eligibility, sales eligibility, or approval requirements. | Share information with importers, customs brokers, and regulatory affairs personnel. |
| When consulted about advertising expressions | Forwarders can inform the importer that confirmation of approval range and pharmaceutical advertising is necessary. | Do not conclude that a certain expression is definitely acceptable or within the approval range. | Connect the importer to its regulatory affairs or legal department for confirmation. |
Required Documents
| Document | What to Confirm | Purpose in Practice |
|---|---|---|
| Product Catalog | Product overview, usage, efficacy, sales destination | Used to verify quasi-drug classification. |
| Ingredient List / Active Ingredient Data | Active ingredients, blended ingredients, purpose of blending | Used to verify scope of approval and classification as a pharmaceutical. |
| Documents Related to Formulation Amounts | Concentration, quantity, and standards of active ingredients | Used to check consistency with approval details and standards. |
| Specification Sheet / COA | Quality standards, test results, ingredient standards | Used for quality and regulatory confirmation. |
| Efficacy Explanation Documents | Planned efficacy and effectiveness, advertising expressions, intended use | Used to confirm whether expressions remain within the approved range. |
| Documents Related to Dosage and Administration | Usage method, frequency, target area, target users | Used to confirm consistency with approved content. |
| Approval Certificates and Related Documents | Product approval, active ingredients, efficacy, dosage, dosage forms | Used to confirm whether the individual item can be marketed. |
| Manufacturing and Marketing Authorization / Manufacturing License Documents | Market shipment responsible party, domestic operation locations, permit status | Used to verify the import and sales system. |
| Foreign Manufacturer Accreditation Documents | Name, location, and manufacturing scope of overseas manufacturing site | Used to verify import procedures from overseas manufacturers. |
| Overseas Labels, Japanese Labeling Drafts, Advertising Text Drafts | Labels, advertising, efficacy claims, caution statements | Used to confirm approval scope and pharmaceutical advertising issues. |
4-Column Judgment Checklist
| Verification Stage | Who to Check With | What to Check | Action if Issues Arise |
|---|---|---|---|
| Before Purchasing | Importer, overseas manufacturer | Product use, ingredients, active ingredients, overseas classification, advertising expressions | If expressions such as medicated appear, conduct classification confirmation. |
| During Classification Confirmation | Importer, regulatory affairs personnel | Whether it qualifies as a cosmetic, quasi-drug, pharmaceutical, or general goods | If unclear, carry out regulatory confirmation before import arrangements. |
| During Active Ingredient Confirmation | Importer, overseas manufacturer, regulatory affairs personnel | Names of active ingredients, formulation amounts, standards, consistency with approval range | If inconsistent with the scope recognized in Japan, revise sales plans. |
| During Authorization and Approval Confirmation | Marketing Authorization Holder, importer, regulatory affairs personnel | Manufacturing and Marketing Authorization, manufacturing license, Foreign Manufacturer Accreditation, product approval | If unconfirmed, organize necessary documents before customs clearance. |
| At Domestic Storage and Labeling | Importer, warehouse, manufacturer | Storage, packaging, labeling, label application, need for manufacturing license | Verify logistics operations separately from manufacturing acts under the PMD Act. |
| At Customs Declaration | Importer, customs broker | Copy of permit, approval documents, ingredient list, active ingredient data, usage explanation | If documents are insufficient, collect additional materials from the importer. |
| When Creating Sales Pages | Importer, advertising personnel, regulatory affairs personnel | Efficacy claims, medicated expressions, treatment expressions, consistency with approval scope | Revise advertising expressions that exceed the approval range. |
| Before Market Shipment | Marketing Authorization Holder, importer | Quality, labeling, approval details, storage condition, market shipment decision | Even after customs clearance, confirm that no sales occur before the market shipment decision. |
Practical Scenario 1: Attempting to Import Overseas Medicated Cosmetics as Cosmetics
There are cases where an importer purchases a medicated skin care product sold overseas and tries to sell it domestically in Japan as a cosmetic.
Expressions such as anti-acne, whitening, medicated, and skin repair are used on overseas product pages.
If the importer simply translates these into Japanese and labels them as "prevents acne," "whitening," or "repairs skin," this could exceed the scope of cosmetics and may require confirmation as a quasi-drug or pharmaceutical product.
In this situation, it is necessary to clarify whether to limit the labeling to expressions valid for cosmetics or to check for approval and permission as a quasi-drug.
Practical Scenario 2: Exceeding the Scope of Efficacy for Medicated Shampoo
There are cases where importers purchase overseas anti-dandruff shampoo and sell it in Japan as a medicated shampoo.
When displaying efficacy such as dandruff and itch prevention, the scope of approval as a quasi-drug, active ingredients, composition amounts, and labeling must be checked.
Additionally, using expressions such as "treats scalp inflammation," "cures hair loss," or "promotes hair growth" may exceed the approval scope.
Importers need to separately confirm the approved efficacy range and advertising expressions.
Practical Scenario 3: Importing Hair Growth Products from Overseas
There are cases where importers purchase overseas hair growth products and plan to sell them in Japan.
While these products may be categorized as quasi-drugs for hair growth promotion, if they claim hair regrowth, treatment of alopecia, or hair loss treatment, they may be problematic as pharmaceutical claims.
In this case, it is necessary to confirm the active ingredients, composition amounts, approved efficacy, advertising content, sales pages, and social media posts.
Because "hair growth promotion" and "hair regrowth" or "treatment" are often confused in practice, it is important to conduct regulatory checks before import.
Practical Scenario 4: Misclassification of Insect Repellent and Insecticide Products
There are cases where importers bring in overseas insect repellent sprays and insecticides.
Depending on whether the product is a repellent for direct use on humans or a control product for indoor or environmental use, as well as the purpose and ingredients for insecticidal or repellent effect, confirmation as quasi-drugs or pharmaceuticals may be required.
Even if marketed overseas as a household product, in Japan it could be treated as a quasi-drug for pest control.
Importers need to confirm the intended use, application area, active ingredients, efficacy, and labeling precautions.
Practical Scenario 5: Unorganized Status of Marketing Authorization Holder and Product Approval
There are cases where importers purchase overseas quasi-drugs and plan to sell them domestically in Japan.
However, it is not organized who will act as the quasi-drug Marketing Authorization Holder for market release, whether product-specific approvals are completed, or whether permissions for domestic storage and labeling locations exist.
Importers often think they are "just importing products sold overseas," but in Japan, the distinctions among Marketing Authorization Holder, manufacturer, foreign manufacturer, and product approval need to be clearly checked.
In such cases, it is necessary to confirm permissions, approvals, labeling, and advertising before customs clearance.
Impact When Customs Clearance or Sales Are Stopped
If goods that could fall under quasi-drugs are inspected, delays in customs clearance, storage fees, delivery delays, postponed sales start dates, advertising revisions, label corrections, and rearrangement of authorized Marketing Authorization Holders may occur.
Even if customs clearance proceeds, without the proper Marketing Authorization Holder, manufacturer, Foreign Manufacturer Accreditation, product approval, labeling, and advertising, domestic sales may not move forward.
Importers should view import clearance and domestic sales as a continuous flow and confirm from before procurement through to market release.
Division of Roles Between Articles on Cosmetics and Pharmaceutical-like Efficacy Claims
The "Cosmetics" article organizes definitions of cosmetics, ingredient regulations, full ingredient labeling, cosmetic advertising, and basic differences from quasi-drugs.
"Pharmaceutical-like Efficacy Claims" is a cross-sectional article organizing judgment criteria for labeling and advertising common to foods, cosmetics, general goods, health devices, and other categories.
In contrast, this article on "Quasi-drugs" organizes quasi-drug-specific active ingredients, scope of efficacy, approvals, permissions, subcategories, and relationships with medicated cosmetics.
In practice, the first step is to check whether the product can be treated as a cosmetic and does not claim pharmaceutical-like efficacy. If it does claim medicinal effects, confirm the quasi-drug classification as organized in this article.
Common Misunderstandings
| Common Misunderstandings | Actual Understanding | Practical Points to Note |
|---|---|---|
| If it says "medicated," it can be sold as a quasi-drug in Japan. | To sell as a quasi-drug in Japan, approval, permission, and confirmation of labeling scope are required. | Do not judge based solely on overseas labeling or product name. |
| If it does not say "medicated," it is not a quasi-drug. | Even if "medicated" is not in the product name, confirmation of quasi-drug status may be necessary based on active ingredients and claimed effects. | Check ingredients, usage, advertising, and sales pages. |
| If it looks like a cosmetic, it can be imported as a cosmetic. | Judgment is made not by appearance but by ingredients, claimed effects, intended use, and advertising expressions. | Pay attention to terms such as medicated, anti-acne, and whitening. |
| If you have Manufacturing and Marketing Authorization, you can sell any product. | Business authorization is separate from product approval. Individual product approvals may be necessary. | Check approval certificates, active ingredients, claimed effects, and usage instructions. |
| If it is a quasi-drug, strong therapeutic claims can be advertised. | Quasi-drugs must display claims only within the scope of approved effects. | Be cautious about claims exceeding approval scope, such as treatment, improvement, or hair regrowth. |
| Labeling in a domestic warehouse is just a simple logistics operation. | Storage, packaging, labeling, and label affixing may require a manufacturing license. | Confirm work details and whether a license is needed in advance. |
| Products successfully imported for personal use can be sold domestically. | Importing for personal use and domestic sales for business are separate matters. | Check approval, permission, labeling, and advertising when selling domestically. |
| If it is sold overseas, it has the same classification in Japan. | Overseas classifications do not necessarily align with Japan’s PMD Act classifications. | Confirm ingredients, claimed effects, labeling, and sales method in Japan. |
Practical Points to Note
Quasi-drugs often appear to lie between cosmetics and pharmaceuticals, which can lead to errors in judgment during import operations.
However, this “middle ground” does not mean it is simpler in practice. Confirmation of active ingredients, formulation amounts, claimed effects, approvals, Manufacturing and Marketing Authorization, manufacturing licenses, Foreign Manufacturer Accreditation, and advertising expressions is necessary.
Especially for products related to beauty, hygiene, hair care, oral care, deodorants, and insect repellents, verifying classification as quasi-drugs is important.
Freight forwarders are not decision-makers under the PMD Act, but for cargo displaying terms such as medicated, anti-acne, anti-dandruff, hair growth, deodorant, or insect repellent, they have a role in confirming with importers and sharing information with customs brokers.
Summary
Quasi-drugs are regulated products under the PMD Act that have milder physiological effects than pharmaceuticals but are used for certain claimed effects.
Even if sold overseas as cosmetics or daily goods, products claiming medicated effects, hair growth promotion, hair removal, sterilization, deodorization, insect repellency, whitening, acne prevention, or similar effects may require confirmation as quasi-drugs in Japan.
For quasi-drugs, confirmation of active ingredients, formulation amounts, approved scope of claimed effects, usage instructions, approvals, Manufacturing and Marketing Authorization, manufacturing licenses, Foreign Manufacturer Accreditation, labeling, and advertising is necessary.
Freight forwarders are not responsible for determining quasi-drug status but should encourage importers to verify suspicious cargo and share information with customs brokers.
Quasi-drugs combine cosmetic appearance with medicated effects, active ingredients, and approved scope directly impacting customs clearance and domestic sales. Pre-import regulatory compliance checks and confirmation of approval scopes are the most critical preventive measures.
