Cosmetics Import and Sales Business License
Interlink編集部What is the Cosmetics Import and Sales Business License?
The Cosmetics Import and Sales Business License is a practical term collectively referring to the approvals and notifications required under the Pharmaceuticals and Medical Devices Act (PMD Act) when importing and selling overseas-made cosmetics in Japan.
However, there is no single formal approval specifically called the “Cosmetics Import and Sales Business License.”
Precisely speaking, it mainly involves the Cosmetics Manufacturing and Marketing Approval, Cosmetics Manufacturing License, product-specific Cosmetics Manufacturing and Marketing Notifications, Foreign Manufacturing Marketing Authorization Holder Notifications, and Foreign Manufacturer Notifications.
In import operations, it is important not only whether cosmetics can clear customs but also whether they are ready for market shipment and sale within Japan.
Even when importing products directly from overseas manufacturers, businesses selling within Japan must act as the responsible party under the PMD Act, managing quality control, safety management, labeling, advertising, notifications, and ingredient verification.
Scope Covered in This Article
| Scope | Contents Organized in This Article | Items to Confirm Separately |
|---|---|---|
| Overall Picture of Approvals and Notifications | This article organizes that the practical term “Cosmetics Import and Sales Business License” is not a single approval but a collective term for multiple approvals and notifications. | The forms, submission destinations, timing, and required documents for individual procedures should be confirmed with administrative offices or experts. |
| Cosmetics Manufacturing and Marketing Approval | This explains the role of the marketing authorization holder as the responsible party for market shipment within Japan. | Requirements for responsible person, quality control system, safety management system, and approval application procedures should be individually confirmed. |
| Cosmetics Manufacturing License | This covers approval related to locations in Japan where storage, packaging, labeling, and labeling application are conducted. | Whether specific tasks performed at warehouses are subject to approval needs to be confirmed depending on the scope of work. |
| Product-by-Product Notifications | This clarifies that besides the Cosmetics Manufacturing and Marketing Approval, product-specific Cosmetics Manufacturing and Marketing Notifications are also involved. | Sales names, product classification, notification contents, and handling of changes should be confirmed with regulatory affairs personnel. |
| Foreign Notifications | This organizes confirmation of overseas manufacturer and manufacturing site information via Foreign Manufacturing Marketing Authorization Holder Notifications and Foreign Manufacturer Notifications. | Obtaining foreign manufacturing source information, necessity of notifications, and responses to changes require expert confirmation. |
| Customs Clearance and Market Shipment | This summarizes commonly required documents such as copies of approvals, notification forms, full ingredient lists, and explanations of use at customs clearance. | Successful customs clearance does not guarantee domestic sales permission; market shipment eligibility should be confirmed by the manufacturing and marketing authorization holder. |
| Freight Forwarder Practice | This organizes what freight forwarders should check and what they should refrain from concluding. | Freight forwarders are not the final decision makers on whether permission or notification is required under the PMD Act. |
Positioning of This Article
This article organizes the concept of approvals and notifications required when importing and selling overseas-made cosmetics in Japan.
Definitions of cosmetics themselves, differences from pharmaceuticals and quasi-drugs, ingredient regulations, full ingredient labeling, and advertising expressions are organized in a separate article titled “Cosmetics.”
This article particularly focuses on who becomes the marketing authorization holder, whether a manufacturing license is required for domestic storage and labeling, whether product-by-product manufacturing and marketing notifications are filed, whether foreign manufacturing marketing authorization holder and foreign manufacturer notifications are required, and what is checked at customs clearance.
In other words, this article is not about whether something qualifies as a cosmetic but is a procedural guide organizing necessary approvals, notifications, and responsible parties for import and sales.
What Exactly Needs to Be Confirmed?
When selling overseas-made cosmetics in Japan, multiple approvals, notifications, and verification items are combined and reviewed in actual logistics practice.
| Item | Main Content | Situations When Required | Common Causes for Obstacles | Practical Response |
|---|---|---|---|---|
| Cosmetics Manufacturing and Marketing Approval | This license establishes the responsible party for market shipment of cosmetics within Japan. | Relevant when importing overseas cosmetics and selling them domestically. | When considered merely as an importer or seller without understanding the responsibilities of a manufacturing and marketing authorization holder. | Determine who will be the manufacturing and marketing authorization holder before import. |
| Cosmetics Manufacturing License | This approval relates to facilities where cosmetics are stored, packaged, labeled, or labeling is applied. | Relevant when storage, labeling, packaging, and labeling are performed at domestic warehouses. | When labeling operations at logistics warehouses are incorrectly viewed as just basic logistics work. | Confirm the licensing category of the workplace and the scope of tasks performed. |
| Cosmetics Manufacturing and Marketing Notification | This is the procedure to notify sales names and other details by individual product. | Required before shipping cosmetics to the market. | Misunderstanding that sales can be conducted without product-specific notifications if an overall manufacturing and marketing approval exists. | Check the notification status for each intended product. |
| Foreign Manufacturing Marketing Authorization Holder Notification | Notification related to overseas marketing authorization holders of cosmetics. | Relevant when importing and selling overseas-made cosmetics. | Delays in obtaining information about the foreign manufacturer. | Confirm overseas manufacturer information during procurement negotiation stage. |
| Foreign Manufacturer Notification | Notification concerning overseas manufacturers of cosmetics. | Confirmed when overseas manufacturing sites are involved. | Inadequate confirmation of manufacturing site name, location, manufacturing scope, etc. | Obtain manufacturing site information early. |
| Labeling and Ingredient Confirmation | Check full ingredient labeling, cosmetics standards, Japanese labeling, and advertising expressions. | Relevant before import, before domestic labeling, and before sales start. | Attempting to use overseas labels or advertising as-is without adjustment. | Prepare Japanese labeling and advertising expressions accordingly. |
What is the Cosmetics Manufacturing and Marketing Approval?
A license for Manufacturing and Marketing of Cosmetics is a permit required to become the responsible entity for shipping cosmetics to the market within Japan.
The term "manufacturing and marketing business operator" here does not simply mean a seller of products.
Under the Pharmaceuticals and Medical Devices Act, the manufacturing and marketing business operator is responsible for product quality control, safety management, market shipment judgment, labeling, recall handling, complaint response, and collection of safety information.
Even when importing cosmetics from overseas manufacturers for sale in Japan, it is necessary to clearly identify who will be the manufacturing and marketing business operator within Japan.
The importer themselves may become the manufacturing and marketing business operator, or the responsibility may be entrusted to a business operator who already holds the relevant license.
What is a License for Manufacturing Cosmetics?
The license for manufacturing cosmetics relates to the manufacturing site where cosmetics are produced, packaged, labeled, stored, and so on.
In the case of imported cosmetics, even if actual manufacturing is not conducted domestically, the license for manufacturing cosmetics may be involved for locations where storage, packaging, labeling, pre-shipment storage, or similar operations take place.
In particular, when cosmetics arriving from overseas are stored in a domestic warehouse, Japanese labels are attached, and then shipped, this may qualify as work requiring a manufacturing license under the Pharmaceuticals and Medical Devices Act rather than just simple warehouse storage.
When logistics companies or warehousing operators are involved, it is necessary to check what scope of work the warehouse performs and whether it holds the appropriate licensing category.
What is a Notification of Manufacturing and Marketing of Cosmetics?
A notification of manufacturing and marketing cosmetics is a procedure to notify the sales name and other information for each product item before shipping cosmetics to the market.
Even if the license for manufacturing and marketing cosmetics is acquired, failure to submit notifications for each product item may prevent individual products from being shipped to the market.
In import operations, it is important to confirm whether the overseas manufacturer's product name will be used as the sales name, if a sales name for the Japanese market will be established, and how items in the same series will be categorized.
The sales name, manufacturing and marketing business operator, foreign manufacturer, ingredients, labeling, and advertising expressions all influence sales operations later on.
Notification of Foreign Manufacturing and Marketing Business Operators / Foreign Manufacturers
When importing cosmetics made overseas for sale in Japan, notifications about foreign manufacturing and marketing business operators and foreign manufacturers may apply.
These relate to notifications concerning entities that manufacture and market or manufacture cosmetics outside Japan.
The importer should confirm the overseas manufacturer's name, address, manufacturing site information, manufacturing scope, and whether the necessary notifications have been filed.
If the overseas manufacturer is inexperienced in providing such information, obtaining the required details for notifications may take time.
Therefore, it is important to confirm necessary information with the overseas manufacturer during the purchasing negotiation phase rather than after import arrangements.
Comparison Between Self-Acquisition and Entrusting to a Licensed Business Operator
| Category | Main Features | Advantages | Points That Often Cause Problems | Practical Measures |
|---|---|---|---|---|
| Obtain manufacturing and marketing license independently | The importer becomes the manufacturing and marketing business operator and assumes responsibility for market shipment. | Allows integrated management of product items, labeling, quality control, and safety management internally. | Significant burdens regarding responsible personnel system, quality control, safety management, procedural manuals, and update management. | Ensure establishment of system, personnel, manuals, and post-sale management before license acquisition. |
| Entrust manufacturing and marketing to a licensed business operator | A business operator who already holds a cosmetics manufacturing and marketing license acts as the manufacturing and marketing business operator. | Allows use of the licensed operator’s infrastructure even if the importer does not hold the license. | May create unclear issues regarding who is displayed as manufacturer, who makes market shipment decisions, and who holds quality responsibility. | Confirm delegation contracts, label attribution, responsibility division, and notification status in writing. |
| Only involved as a seller | The importer or seller remains only the sales contact, not as the manufacturing and marketing business operator. | Allows focus on sales activities, although cooperation with the manufacturing and marketing business operator is required. | Risk that the seller may not understand the manufacturing and marketing operator's responsibilities and changes advertisements or labeling improperly. | Coordinate with the manufacturing and marketing business operator on sales pages, advertisements, and labeling changes. |
| Importing with vague role division | The roles of importer, seller, manufacturing and marketing operator, warehouse, and overseas manufacturer are not clearly defined. | May appear to progress arrangements in the short term. | Could cause delays in customs, domestic labeling, market shipment, advertising, and complaint handling. | Finalize responsible entities, domestic processing sites, notifications, and labeling before ordering. |
If the Importer Obtains the License Themselves
The importer can choose to obtain the cosmetics manufacturing and marketing license themselves and act as the manufacturing and marketing business operator for market shipment.
In this case, the importer is not simply a seller but the responsible entity under the Pharmaceuticals and Medical Devices Act.
They need to establish quality control, safety management, responsible personnel structure, procedural manuals, record keeping, complaint handling, and recall measures.
When obtaining the license independently, attention must be paid to license application, on-site inspection, responsible person requirements, operational structure, and renewal procedures.
When Entrusting to a Licensed Business Operator
If the importer does not have a cosmetics manufacturing and marketing license themselves, they may entrust the role to a business operator who already holds the license.
In this case, it is essential to clarify who is displayed as the manufacturing and marketing business operator, who makes the market shipment decision, and who is responsible for quality and safety management.
Role division among the seller, importer, manufacturing and marketing business operator, domestic storage warehouse, and overseas manufacturer should be clearly defined; otherwise, issues with labeling, notifications, or responsibilities may arise.
When Labeling and Storage Are Done at a Domestic Warehouse
If imported cosmetics have Japanese labels applied, packaging changed, or are stored pre-shipment at a domestic warehouse, the licensing category of that warehouse becomes an important consideration.
Even in logistics warehouses, if tasks subject to packaging, labeling, or storage under the Pharmaceutical and Medical Device Act are performed, a cosmetics manufacturing license may be required.
Freight forwarders and warehousing companies need to confirm with importers whether the operation involves simple storage or includes label attachment and packaging work.
If logistics arrangements proceed without verifying the scope of domestic operations, issues may arise such as shipments being blocked after import, inability to perform labeling work, or the need for re-arrangements.
Regulatory Application Flow
- Confirm whether the imported product is likely classified as a cosmetic, quasi-drug, or pharmaceutical product.
- If treated as a cosmetic, check the ingredients, cosmetic standards, full ingredient disclosure, and Japanese labeling.
- Determine who will be the cosmetics manufacturing and sales business operator within Japan.
- Decide whether to obtain the manufacturing and sales license in-house or delegate to a licensed operator.
- Check whether a cosmetics manufacturing license is required for the place where storage, packaging, labeling, or display operations occur domestically.
- Verify the cosmetic manufacturing and sales notifications for each item.
- Obtain necessary overseas manufacturer information for the foreign manufacturing and sales business notification and foreign manufacturer notification.
- Prepare copies of permits, notification documents, product materials, full ingredient lists, and usage explanations required at customs clearance.
- Before market shipment, the manufacturing and sales business operator should verify quality, labeling, notification status, labels, and storage conditions.
- Before starting sales, review the expressions used in e-commerce sites, advertisements, social media, landing pages, and brochures.
- After sales begin, continue to manage complaint handling, safety information, recalls, and label change controls.
Practical Workflow Until Import and Sales
| Stage | Main Confirmation Points | Common Causes for Delays |
|---|---|---|
| Procurement Review | Verify whether the product is classified as a cosmetic, quasi-drug, or pharmaceutical product. | Assuming the product is a cosmetic in Japan because it is labeled as "cosmetics" overseas. |
| Overseas Manufacturer Confirmation | Obtain manufacturer information, ingredient lists, INCI names, specifications, COAs, and manufacturing site details. | When ingredient or manufacturing site information cannot be obtained from the overseas manufacturer. |
| Permit and Notification Check | Confirm whether manufacturing and sales licenses, manufacturing licenses, manufacturing sales notifications, or foreign notifications are required. | Assuming permits are obtained, but product notifications or foreign notifications are not confirmed. |
| Import Arrangement | Organize copies of permits, notification documents, and product materials necessary at customs clearance. | Discovering missing documents just before customs clearance. |
| Domestic Storage and Labeling | Confirm domestic warehouse manufacturing licenses, Japanese labels, and full ingredient labeling requirements. | Failing to check the license category of the warehouse performing label attachment. |
| Market Shipment Decision | The manufacturing and sales business operator reviews quality, labeling, and notification status to decide on market shipment. | Mistakenly assuming sales are allowed just because customs clearance was completed. |
| After Sales Begin | Manage advertising expressions, complaint handling, safety management, and recall processes. | Not establishing a post-sales safety management system. |
Documents Commonly Checked at Customs Clearance
| Documents | Contents Checked | Purpose in Practice |
|---|---|---|
| Copy of Cosmetics Manufacturing and Sales License | Whether there is a responsible entity for market shipment within Japan | Verify the permit system of the importer or related businesses. |
| Copy of Cosmetics Manufacturing License | License for the domestic site where storage, packaging, labeling, and display occur | Confirm legality of the domestic operation location. |
| Copy of Cosmetics Manufacturing and Sales Notification | Notification status per item, product name, licensee | Confirm product readiness for market shipment. |
| Documents relating to Foreign Manufacturing and Sales Business Notification and Foreign Manufacturer Notification | Overseas manufacturer, manufacturing site, location, manufacturing scope | Used to organize information on overseas manufacturers. |
| Product Catalog | Product overview, uses, efficacy claims, labeling in sales countries | Used to determine classification as cosmetic, quasi-drug, or pharmaceutical product. |
| Full Ingredient List and INCI Name List | Formulated ingredients, ingredient names, labeling names, ingredient composition | Used to verify cosmetic standards and full ingredient labeling. |
| Specifications and COA | Quality standards, ingredient confirmation, analysis results, product specifications | Used as grounds for ingredient and quality verification. |
| Usage and Sales Purpose Explanation | Whether for personal or business use, sales destination, usage method | Used to check regulations at customs clearance. |
| Japanese Label Draft and Overseas Label | Full ingredient listing, manufacturer labeling, usage precautions | Used to verify labeling requirements for domestic sales. |
| Invoice and Packing List | Product names, quantity, price, importer, cargo details | Cross-check customs declarations with documents related to the Pharmaceutical and Medical Device Act. |
Relation to Labeling and Advertising
Even if the cosmetics import and sales licenses and notifications are properly arranged, labeling and advertising are not unrestricted.
In cosmetics, the permissible range for efficacy and effect claims on labels is limited.
Expressions that claim treatment, prevention, or improvement of diseases, or that strongly affect bodily functions, may raise issues as medicinal effects under the law.
Using overseas manufacturers’ advertisements, product descriptions, user reviews, comparative images, social media posts, or video explanations as-is for Japan may violate advertising regulations under the Pharmaceutical and Medical Device Act.
Not only product labels, but also e-commerce sites, social media, brochures, video explanations, landing pages, and email advertisements are subject to review.
Key Points for Freight Forwarders and Customs Practice
Freight forwarders and customs-related personnel need to confirm whether the importer has completed the necessary Pharmaceutical and Medical Device Act (PMDA) compliance required for domestic sales, even when importing cosmetics.
The freight forwarder is not in a position to make the final judgment on the necessity of cosmetic manufacturing and marketing business permits or manufacturing permits.
However, if the import is for the purpose of sales, it is necessary to confirm with the importer whether the import is for sales or personal use, which category the product might fall under—cosmetics, quasi-drugs, or pharmaceuticals—and whether a manufacturing and marketing authorization holder is involved.
Additionally, it should be checked whether labeling, packaging, and storage operations will be conducted domestically, whether the domestic work location holds a cosmetic manufacturing business permit, whether marketing notifications for each item have been submitted, if a foreign notification is necessary, and whether full ingredient listings and Japanese labeling are prepared.
If customs inquiries arise, the freight forwarder should collect copies of permits, notification documents, product documentation, full ingredient lists, and usage explanations from the importer, and communicate this information to the customs broker.
Freight forwarders should avoid making definitive statements such as “Permits are not necessary” or “Since it is a cosmetic, there is no problem.”
Scope of freight forwarder involvement
| Situation | What can be supported | What should not be definitively stated | Practical response |
|---|---|---|---|
| When it is identified as importing cosmetics for sales purposes | You can confirm with the importer whether permits and notifications have been completed. | You should not definitively state that manufacturing and marketing permits or manufacturing permits are unnecessary. | Share information with the customs broker early. |
| When requested to present permits or notification documents | You can collect copies of permits and notification documents from the importer and relay them to the customs broker. | You should not respond that there is no problem without having these documents. | Make a checklist of missing documents and request them from the importer. |
| When labeling is applied at a domestic warehouse | You can urge confirmation of the cosmetic manufacturing business permit for the work site. | Do not definitively state that labeling is just a logistics operation and thus permits are unnecessary. | Check the scope of work, warehouse permit, and contract for outsourcing. |
| When overseas manufacturer information is insufficient | You can request the importer to obtain the name of the manufacturing site, location, and manufacturing scope. | You should not assume that the manufacturer’s name alone is sufficient for foreign notification. | Prompt the importer to obtain necessary information during purchasing negotiations. |
| When consulted about advertising expressions | You can advise that advertising confirmation falls under pharmaceutical affairs, labeling, and legal compliance checks. | You are not in a position to approve expressions on sales pages. | Encourage the importer to have specialists review the content. |
| When customs clearance is halted | You can organize missing documents, regulatory confirmation items, and inquiries from the customs broker. | A freight forwarder should not make the final decision on permit necessity or sales authorization. | Connect the importer, customs broker, and pharmaceutical compliance personnel for confirmation. |
Common problematic cases in actual logistics practice
| Case | What becomes an issue | Documents to confirm | Practical response |
|---|---|---|---|
| Sales purpose but no manufacturing and marketing authorization holder decided | The responsible party for market release is unclear, preventing progress to domestic sales. | Sales plan, outsourcing contracts, manufacturing and marketing business permit | Decide whether the importer will acquire the permit themselves or outsource to a licensed operator. |
| Manufacturing and marketing business permit exists but notification of individual items not confirmed | Even with a permit, specific products may not be authorized for market release. | Cosmetic manufacturing and marketing notification, sales name, item list | Confirm notification status for each item. |
| Applying Japanese labels at a domestic warehouse | Manufacturing permits may become an issue for packaging, labeling, and storage activities. | Warehouse permit, scope of work, label drafts, outsourcing contract | Confirm the permit category for the work location. |
| Unable to obtain foreign manufacturer information | Foreign notification and domestic procedures may not progress. | Overseas manufacturer information, manufacturing site name, location, manufacturing scope | Check whether essential information can be obtained before placing orders. |
| Ingredient information is insufficient just before customs clearance | Cosmetic standards and labeling confirmation stall, delaying customs clearance and sales. | Full ingredient list, INCI names, specifications, COA | Obtain required documents from the manufacturer before procurement. |
| Issue arises with advertising despite having permits and notifications | Advertising may exceed the scope of cosmetic efficacy, potentially violating the Pharmaceutical and Medical Device Act. | EC site pages, landing pages, SNS posts, ad text, overseas advertisements | Confirm Japan-directed advertising expressions before sales launch. |
| Importer and seller are different entities | It becomes unclear who is listed as the manufacturing and marketing authorization holder and who assumes quality and safety management responsibilities. | Contracts, permits, labeling plans, sales system documentation | Document role division clearly. |
| Items imported for personal use are diverted to sales | Personal use imports and commercial imports are mixed. | Quantity data, sales destinations, EC listings, purchase history | Confirm permits, notifications, and labeling for commercial imports. |
4-Column Decision Checklist
| Check Point | Party to Confirm With | Items to Confirm | Actions if Issues Arise |
|---|---|---|---|
| At Purchase Consideration | Importer, Overseas Manufacturer | Whether the product may fall under cosmetics, quasi-drugs, or pharmaceuticals | If medicinal claims or treatment expressions are present, pharmaceutical law checks are conducted. |
| At Permit Holder Confirmation | Importer, Permit Holder | Who will act as the cosmetics manufacturing and marketing authorization holder for market shipment | If undecided, decide whether to obtain the permit in-house or outsource to a permit holder. |
| At Domestic Handling Confirmation | Importer, Warehouse, Manufacturer | Where storage, packaging, labeling, and label application will be performed | Confirm if the work requires a manufacturing business permit under the Pharmaceutical and Medical Device Act. |
| At Product Notification Confirmation | Marketing Authorization Holder, Pharmaceutical Affairs Personnel | Sales name, cosmetics manufacturing and marketing notification for each product, notification status | If not notified, confirm procedures before market shipment. |
| At Foreign Notification Confirmation | Importer, Overseas Manufacturer, Pharmaceutical Affairs Personnel | Foreign marketing authorization holder, foreign manufacturer, manufacturing site information | If information is insufficient, confirm with the manufacturer before ordering. |
| At Customs Clearance Confirmation | Customs Broker, Importer | Copies of permit, notification forms, full ingredient list, intended use explanations, invoice | If documents are insufficient, obtain additional materials from the importer. |
| Before Market Shipment | Marketing Authorization Holder, Manufacturer, Importer | Quality, labeling, notification status, label, storage condition, shipment decision | Even after customs clearance, confirm no sales before shipment decision. |
| Before Sales Start | Importer, Advertising Personnel, Pharmaceutical Affairs / Legal Department | Advertising, e-commerce pages, SNS, landing pages, efficacy claims | Correct any expressions exceeding the scope of cosmetics. |
Practical Scenario 1: When the Permit Holder Is Not Decided Despite Sales Purpose
There are cases where the importer purchases overseas cosmetics intending to sell them online (EC) in Japan.
However, who will act as the cosmetics manufacturing and marketing authorization holder for market shipment has not been decided.
The importer thinks they are simply selling the overseas manufacturer’s products as-is, but in Japan, a responsible entity for market shipment is required.
In this case, it is necessary to decide whether to acquire the cosmetics manufacturing and marketing business permit in-house or to outsource it to a permit holder.
Practical Scenario 2: Permit Exists but Product Notification Confirmation Is Pending
There are cases where the importer collaborates with an operator holding a cosmetics manufacturing and marketing business permit to import overseas cosmetics.
However, whether a cosmetics manufacturing and marketing notification has been submitted for each product has not been confirmed.
Having a permit does not necessarily mean each individual product can be shipped to market.
In this case, it is necessary to check the sales name, notification status, foreign manufacturer information, and full ingredient list before proceeding to market shipment.
Practical Scenario 3: Applying Japanese Labels at a Domestic Warehouse
There are cases where imported cosmetics receive Japanese labels applied at a domestic warehouse before shipment.
The importer considers labeling at a logistics warehouse simply a routine warehouse operation.
However, labeling, packaging, and storage tasks related to cosmetics can require a manufacturing business permit under the Pharmaceutical and Medical Device Act.
In this case, it is necessary to confirm the permit classification of the location where label application is performed, the scope of work, and the role allocation with the manufacturing and marketing business operator.
Practical Scenario 4: Foreign Manufacturer Information Unavailable, Delaying Notification
There are cases where importers attempt to procure cosmetics from overseas brands.
However, the overseas manufacturer does not sufficiently provide the manufacturing site name, location, manufacturing scope, or marketing authorization holder information.
Without complete information required for the foreign marketing authorization holder notification or foreign manufacturer notification, domestic procedures may not progress.
Importers need to confirm with overseas manufacturers before negotiating price or placing orders whether they can provide information necessary for Japanese pharmaceutical affairs procedures.
Practical Scenario 5: Permits and Notifications Are Complete but Advertising Causes Issues
There are cases where the importer has prepared the cosmetics manufacturing and marketing business permit, product notifications, and Japanese labeling, then sells overseas cosmetics.
However, they sometimes directly translate overseas advertisements on e-commerce sites using expressions like "removes spots," "cures inflammation," or "regenerates cells."
Even if permits and notifications are in place, advertising expressions exceeding the scope of cosmetics could pose issues under the Pharmaceutical and Medical Device Act.
Importers need to review not only permits and notifications but also Japan-targeted advertising expressions before starting sales.
Impact When Customs Clearance or Sales Are Halted
If permit and notification confirmations for cosmetics import and sales are insufficient, delays in customs clearance, storage fees, delivery delays, deferred sales start, label correction costs, advertising revision expenses, and rearrangement of permit holders may occur.
Even if customs clearance is achieved, without organized manufacturing authorization, manufacturing site permits, product notifications, foreign notifications, full ingredient declarations, and advertising compliance, domestic sales may not proceed.
Importers should not separate customs clearance and domestic sales but verify the entire flow from procurement to market shipment as a continuous process.
Role Division from the Cosmetics Article
The "Cosmetics" article organizes the definition of cosmetics, differences from quasi-drugs, ingredient regulations, full ingredient listing, advertising expressions, and the overall import logistics process.
By contrast, this article, "Cosmetics Import and Sales Business Permit," specializes in organizing the manufacturing and marketing business permits, manufacturing business permits, product notifications, foreign notifications, and responsible entities necessary for importing and selling overseas cosmetics in Japan.
After confirming whether the product qualifies as cosmetics or quasi-drugs and checking ingredients and advertising compliance, this article clarifies who will act as the marketing authorization holder for market shipment and where labeling and storage will be conducted.
Common Misunderstandings
| Misunderstanding | Correct Understanding | Practical Notes |
|---|---|---|
| There is a single permit called "Cosmetics Import Sales Business Permit" | This is a practical term; officially, multiple permits and notifications must be confirmed. | Separate confirmation is needed for Manufacturing Sales Business Permit, Manufacturing Business Permit, item notifications, and foreign notifications. |
| If you have a Cosmetics Manufacturing Sales Business Permit, you can sell anything | Notifications by product, ingredients, labeling, foreign notifications, and market shipment judgment must also be confirmed. | Do not confuse permits with item notifications. |
| If the importer is the seller, they automatically become the manufacturing sales business operator | Who assumes responsibility as the manufacturing sales business operator must be clearly determined. | Confirm the name for labeling, contracts, and responsibilities for quality and safety management. |
| Labeling in a domestic warehouse is just a regular logistics operation | If it falls under packaging, labeling, or storage, the Cosmetics Manufacturing Business Permit can become an issue. | Confirm the scope of operations and the corresponding permit classification. |
| As long as customs clearance is done, sales are permitted | Customs clearance and market shipment/domestic sales are separate matters. | Confirm market shipment judgment by the manufacturing sales business operator. |
| Overseas manufacturer information can be checked after product arrival | It is needed for foreign notifications and filing documentation, so it should be confirmed during the sourcing negotiation stage. | Obtain the manufacturer's name, location, and manufacturing scope early. |
| Once permits and notifications are in place, advertising expressions are unrestricted | Advertising must be separately checked to ensure it is within cosmetic efficacy claims. | Check e-commerce sites, social media, landing pages, and advertising texts before sales. |
| A freight forwarder can explain that no permit is required | Freight forwarders are not in a position to determine permit requirements under the Pharmaceutical and Medical Device Act. | Connect the importer, customs broker, and regulatory affairs contact for confirmation. |
Practical Notes
The phrase "Cosmetics Import Sales Business Permit" is used in practice, but officially it is necessary to confirm multiple permits and notifications.
Specifically, the Cosmetics Manufacturing Sales Business Permit, Cosmetics Manufacturing Business Permit, Cosmetics Manufacturing Sales Notifications by item, Foreign Manufacturing Sales Business Notifications, and Foreign Manufacturer Notifications each have different roles.
Importers must confirm not only product sourcing but also who bears responsibility for market shipment in Japan, domestic storage and labeling locations, item notifications, overseas manufacturer information, as well as labeling and advertising expressions.
Freight forwarders are not decision makers under the Pharmaceutical and Medical Device Act, but in cosmetics import for sales purposes, they should confirm early whether importers have checked the necessary permits and notifications and share this information with customs brokers.
Summary
“Cosmetics Import Sales Business Permit” is a practical term summarizing the permits and notifications required under the Pharmaceutical and Medical Device Act to import and sell foreign-made cosmetics in Japan.
Officially, the Cosmetics Manufacturing Sales Business Permit, Cosmetics Manufacturing Business Permit, item-specific Cosmetics Manufacturing Sales Notifications, Foreign Manufacturing Sales Business Notifications, and Foreign Manufacturer Notifications must be confirmed separately.
Importers need to verify who acts as the manufacturing sales business operator responsible for market shipment, whether permits cover domestic storage and labeling locations, whether item notifications are complete, and whether overseas manufacturer information is obtained.
Freight forwarders are not authorities on permit requirements but in cosmetics import for sales purposes, they have a role to encourage importers to confirm permit copies, notification documents, product data, full ingredient lists, and usage explanations.
The Cosmetics Import Sales Business Permit is not a single official permit name but a practical coordination point covering responsibility entities, domestic operation sites, item notifications, foreign notifications, and labeling/advertising for import and sales compliance.
