Selling cosmetics under your own brand in Japan: the marketing-authorisation licence vs the manufacturing licence, the three officers, and the procedure

In short: to sell cosmetics under your own brand, you first need a cosmetics marketing-authorisation licence (Article 12 of the Pharmaceuticals and Medical Devices Act, "the Act") — the licence that ships to market and bears final responsibility. A separate cosmetics manufacturing licence (Article 13) is needed at the site that makes, packs, labels or stores (before shipping decision) the product, and importing to sell under your own name generally needs both.

Sources checked: 24 October 2026. This article organises the difference between the two licences, the three officers and GQP/GVP for businesses that want to sell cosmetics under their own brand through OEM or import. The law's name is the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices and Other Products ("the Act"), and the provisions were reconciled by law name on e-Gov. Each ministerial ordinance's number and final amendment date, the cabinet-order article setting the licence's validity period, and each municipality's fees, standard processing periods and credit requirements remain unverified. The competent prefecture (pharmaceutical-affairs section) and qualified professionals assess individual licensing.

What is the difference between a cosmetics "marketing-authorisation licence" and a "manufacturing licence"?

They are two separate licences with different purposes; both must be in place before you can put a self-branded cosmetic on the market. Kanagawa Prefecture's guidance (referenced 24 October 2026) describes the marketing-authorisation licence as "a licence to ship products to market; this licence does not allow manufacturing," and the manufacturing licence as "a licence to manufacture (including packing, labelling and storage before the shipping decision); this licence does not allow shipping to market." The marketing-authorisation holder bears final responsibility for the product.

Type of licence	Basis	What it allows	What it does not allow
Cosmetics marketing-authorisation licence	Article 12 of the Act	Shipping to market; final responsibility	Manufacturing itself
Cosmetics manufacturing licence	Article 13 of the Act	Manufacturing, packing, labelling, pre-shipping storage	Shipping to market

The marketing-authorisation licence is, in principle, granted by the prefectural governor for the location of the office with the main function. The manufacturing licence is granted, for each manufacturing site, by the prefectural governor for that site. The licence has a validity period (generally stated as five years) and lapses if not renewed before expiry. The renewal timing and the cabinet-order article setting the period must be confirmed in municipal guidance and the cabinet order; this article gives no fixed value (unverified).

How is a cosmetics manufacturing licence divided into categories?

The manufacturing licence is divided by the processes it allows. Aichi Prefecture's guidance (referenced 24 October 2026) treats "general" as the category that can perform integrated manufacture, and "packing, labelling and storage" as the category that cannot perform bulk manufacture or filling and may only pack into containers, label, store and inspect. Filling into containers and other primary packaging needs the "general" category.

Manufacturing-licence category	Processes allowed
General	Integrated manufacture of cosmetics (including filling and other primary packaging)
Packing, labelling, storage	Secondary packaging, label application, storage and inspection only (no bulk manufacture or filling)

If you only plan and make shipping decisions in-house and outsource the manufacture, you hold the marketing-authorisation licence and leave the manufacture to a contractor that holds a manufacturing licence. Which category you need depends on which processes you keep in-house.

Do you need a marketing-authorisation licence even just to import and sell?

Yes. Even for cosmetics made abroad, it is the domestic marketing-authorisation holder who ships to the domestic market and bears final responsibility. Kanagawa Prefecture's guidance (referenced 24 October 2026) states that "where you import and ship to market as your own product," both the marketing-authorisation licence and a manufacturing licence (category: packing, labelling, storage) are needed, and notes that "even when importing a product that already carries Japanese labelling, you must store it once at a domestic manufacturing site and conduct the necessary testing and inspection."

The licences you need change with the form of trade. If you outsource the import itself to another company holding a manufacturing licence and have it ship as its product, your own marketing-authorisation licence may suffice. Where you handle only the import and storage and ship under another's name, a packing-labelling-storage manufacturing licence is said to be required. Confirm which case applies with the competent pharmaceutical-affairs section (this article makes no judgement on an individual trade pattern).

Note that cosmetics must follow a pre-marketing notification (marketing notification) for each sales name, and restrictions on ingredients that may be blended (prohibited and restricted ingredients, rules on preservatives, UV absorbers, tar colours, and so on). This article does not give a definitive view on individual ingredients or labelling (the details and latest operation are unverified and need confirmation from the competent authority and qualified professionals).

Who may be the three officers, including the marketing-authorisation supervisor?

At the centre of the marketing-authorisation structure are the three officers known in practice as the "three officers": the marketing-authorisation supervisor under Article 17 of the Act, the quality-assurance officer under the GQP ordinance, and the safety-management officer under the GVP ordinance. On the manufacturing side, a responsible engineer is placed at each manufacturing site.

Role	Position	Basis
Marketing-authorisation supervisor	Oversees quality management and post-marketing safety management	Article 17 of the Act
Quality-assurance officer	Handles quality-management operations	GQP ordinance
Safety-management officer	Handles post-marketing safety management	GVP ordinance
Responsible engineer	Manufacturing and quality control at the site	Manufacturing (per site)

The qualification for a cosmetics marketing-authorisation supervisor rests on Article 17 of the Act and Article 85 of its enforcement regulation. Kyoto Prefecture's guidance (referenced 24 October 2026) lists, as cosmetics categories, a pharmacist; a person who completed a specialist course in pharmacy or chemistry at a high school or an equivalent or higher school; and a person who, after acquiring subjects in pharmacy or chemistry at such a school, worked for three years or more in quality-management or safety-management operations for pharmaceuticals, quasi-drugs or cosmetics. The range of qualification is broader than for pharmaceuticals, and a non-pharmacist may meet the requirement — a feature of cosmetics. The treatment of required credits etc. differs by municipality (Tokyo's guidance states 12 credits or more). Confirm the definitive requirement in the competent authority's latest guide.

What structure do GQP and GVP require?

A marketing-authorisation licence presupposes not only placing people but being able to document and operate the systems that manage quality and safety — that is GQP (the quality-management standard) and GVP (the post-marketing safety-management standard). Kanagawa Prefecture's guidance (referenced 24 October 2026) gives the GQP ordinance as the "Ministerial Ordinance on Standards for Quality Management of Pharmaceuticals, Quasi-drugs, Cosmetics and Regenerative Medicine Products" and the GVP ordinance as the "Ministerial Ordinance on Standards for Post-Marketing Safety Management of Pharmaceuticals, Quasi-drugs, Cosmetics, Medical Devices and Regenerative Medicine Products."

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• GQP: prepare procedure documents to secure product quality, and set up a structure for managing manufacturing sites, deciding whether to ship, and handling recalls.
• GVP: set up a structure to collect and examine quality and safety information after marketing and connect it to necessary measures (recalls, information provision, and so on).

The application attaches an organisation chart, procedure documents and documents certifying the three officers' qualifications. The ordinances' formal numbers, final amendment dates and attachment forms must be confirmed in the ordinance texts and municipal guidance; this article gives no fixed value (unverified).

Who handles licensing, import customs and tax? (Separating the engagements)

Getting a self-branded cosmetic to market combines work of different kinds — the licensing, building the structure, the import and the tax. The basic approach is to engage a separate specialist for each.

Who to engage	Scope
四葉行政書士事務所	Preparing the marketing-authorisation and manufacturing licence documents
Customs broker	Customs clearance at import
Tax accountant	Consumption tax, customs duty and other tax on imports
Pharmacists and other qualified persons	Taking up the three-officer or responsible-engineer posts; quality and safety judgements
四葉社会保険労務士事務所	Employment, work rules and social-insurance design for staff

四葉行政書士事務所, 四葉社会保険労務士事務所 and 四葉不動産株式会社 are each a separate, independent business. The customs broker and tax accountant are also independent businesses separate from our office. You contract with each field's provider separately, and each provider bills and receives payment directly. Our office receives no referral fee. The three-officer and responsible-engineer posts are taken up by qualified persons in their own name and cannot be filled by proxy. The prefecture's pharmaceutical-affairs section is the administrative point of contact for the licence, not a party engaged under a professional-services contract.

See permits and licensing support, the engagement process and the fee schedule. Selling or leasing medical devices is a separate system — see the sales/lease licence for highly controlled medical devices — and a retail store handling drugs is covered in the store-sales permit. A cosmetics marketing-authorisation and manufacturing licence has different governing provisions and categories from these.

FAQ

Q. Do I need a marketing-authorisation licence even if I only do OEM (outsourced manufacture) and don't make anything myself?
A. Even if you outsource the manufacture, a cosmetics marketing-authorisation licence is required as long as you ship to market under your own brand (Article 12 of the Act). The manufacture itself is done by a contractor holding a manufacturing licence, while you make the shipping decision and bear final responsibility. The need for a licence changes with the form of trade, so confirm with the competent pharmaceutical-affairs section.

Q. Do I also need a manufacturing licence to sell imported cosmetics?
A. If you import and ship under your own name, a manufacturing licence (packing-labelling-storage category) is said to be required in addition to the marketing-authorisation licence. Even with Japanese labelling already applied, you must store the product at a domestic site and conduct testing and inspection (Kanagawa, referenced 24 October 2026). Depending on the outsourcing arrangement, the marketing-authorisation licence alone may suffice.

Q. Must one be a pharmacist to serve as one of the three officers?
A. A cosmetics marketing-authorisation supervisor is not limited to pharmacists. A person who completed a pharmacy or chemistry course at a high school or above, or who acquired pharmacy or chemistry subjects and then worked three years or more in quality- or safety-management operations, may also qualify (Article 17 of the Act, Article 85 of the enforcement regulation; Kyoto, referenced 24 October 2026). The treatment of required credits differs by municipality, so confirm in the competent authority's guide.

Q. How long does licensing take, and what does it cost?
A. Fees are set by prefectural ordinance, and the standard processing period is shown in each municipality's review criteria. It varies with how ready the three officers, the GQP/GVP procedure documents and the manufacturing or storage facilities are. This article gives no fixed amounts or days (the variation is large and we have not verified them, so they remain unverified). Confirm the latest guide with the competent pharmaceutical-affairs section.

Sources (Primary Information)

• e-Gov: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices and Other Products (1960 Act No. 145): Article 12 (marketing-authorisation licence), Article 13 (manufacturing licence), Article 17 (placement of the marketing-authorisation supervisor etc.). The detail of paragraphs and items, the cabinet-order article setting the licence's validity period, and final amendment dates and full commencement histories were not obtained (unverified).
• Kanagawa Prefecture: on manufacturing, importing or marketing cosmetics: the difference between the marketing-authorisation licence (shipping to market, final responsibility) and the manufacturing licence (manufacturing, packing, labelling, storage); that importing to ship under one's own name needs the marketing-authorisation licence plus a manufacturing licence (packing-labelling-storage category); the names of the GQP and GVP ordinances (referenced 24 October 2026).
• Aichi Prefecture: guide to cosmetics marketing-authorisation and manufacturing licences (manufacturing-licence categories): the "general" and "packing, labelling, storage" categories and their processes (referenced 24 October 2026). Ordinance numbers and fixed fees vary by municipality and remain unverified.
• Kyoto Prefecture's guide to the cosmetics marketing-authorisation business: the qualification categories for a cosmetics marketing-authorisation supervisor (pharmacist; completion of a pharmacy/chemistry course; three or more years of relevant work), organised under Article 17 of the Act and Article 85 of the enforcement regulation (referenced 24 October 2026). The treatment of required credits varies by municipality and remains unverified.

Checked 24 October 2026. Article numbers are limited to what was reconciled by law name on e-Gov. The detail of paragraphs and items, each ordinance's number and final amendment date, the cabinet-order article setting the validity period, attachment forms, fees and standard processing periods, and required credits remain unverified and should be reconfirmed in the competent authority's latest guidance before filing.

This is general information and does not guarantee the grant of an individual licence, the officers' or responsible engineer's eligibility, ingredient or labelling conformity, or processing time or cost. Judgements on cosmetics quality and safety are made by qualified professionals such as pharmacists, and the final decision on a licence is made by the competent authority. Written by Joji Uramatsu, administrative scrivener and licensed real-estate transaction specialist.