Japanese Cosmetics MAH for Foreign Brands

Two licences, two functions

Japanese cosmetics regulation distinguishes between manufacturing and marketing as separate regulated activities, each requiring its own licence:

• 化粧品製造業 (Cosmetics Manufacturing Licence).Authorises a Japanese site to produce, package, or label cosmetics. Held by the factory.
• 化粧品製造販売業 (Cosmetics MAH Licence).Authorises a Japanese entity to place finished cosmetics on the Japanese market, with responsibility for product safety, quality, post-market surveillance, and recall management. The MAH is the entity Japanese authorities will hold accountable for product safety throughout the lifecycle.

For an OEM relationship, the Japanese OEM factory holds the manufacturing licence; the MAH licence is held by whichever Japanese-domiciled entity actually puts the goods on the market — sometimes the factory, sometimes a separate Japanese marketing-side entity, sometimes a distributor.

Why the MAH licence matters for foreign brands

A foreign brand wishing to sell its OEM-made cosmetics in Japan cannot itself hold the MAH licence — Japanese statute requires the holder to be Japanese-domiciled with a Japanese registered office. Three routes for accessing the market:

1. The OEM factory acts as MAH. Common for brands that want minimum administrative burden. The factory takes both manufacturing and MAH responsibility; the foreign brand simply pays for production and takes delivery. Limitation: control over post-market surveillance, recall management, and label changes sits with the factory.
2. A third-party Japanese MAH service provider.Specialist regulatory firms in Japan act as MAH for brands that want a separate marketing-side entity but do not want to establish their own. The MAH provider takes legal responsibility for the safety side; the brand handles commercial activities through its own importer or distributor arrangement.
3. A Japanese subsidiary of the foreign brand holds the MAH licence. Suitable for brands with significant Japan ambitions. Requires establishing a Japanese subsidiary (KK or GK — see Setting Up a Japanese Subsidiary) and obtaining the MAH licence in the subsidiary's name. Maximum control and ownership of the regulatory relationship, but with the overhead of running a Japanese regulated entity.

What the MAH actually does day-to-day

Foreign brands evaluating the MAH options often underestimate the operational responsibilities involved. The MAH must:

• Appoint and retain three statutory officers — the General Marketing and Quality Assurance Manager (総括製造販売責任者), Quality Assurance Manager (品質保証責任者), and Safety Management Manager (安全管理責任者) — each with statutory qualification requirements.
• Maintain a quality assurance system (QAS) and a safety management system (SMS) under GVP and GQP standards.
• Approve and record each product's specification before it is placed on the Japanese market.
• Manage label content, conformity with the Pharmaceutical Affairs Act and labelling rules, and any required pre-market notifications.
• Receive and investigate complaints and adverse event reports from the market; file mandatory reports to authorities as required.
• Lead any recall, including coordinating with the OEM factory, distributors, retailers, and consumers.
• Cooperate with periodic regulatory inspections by the prefectural authority.

Choosing between routes

Most foreign brands begin with Route 1 (factory-as-MAH) or Route 2 (third-party MAH) and move to Route 3 (own subsidiary) as Japan revenue justifies the investment.

• Route 1 (factory-as-MAH).Right for low volumes, single-product launches, and brands whose Japan strategy is opportunistic. Downside: any change in the OEM relationship requires re-paperwork because the MAH name on the product is the factory's.
• Route 2 (third-party MAH). Right for brands with multiple OEM partners or with a roadmap of new products where the MAH should not be tied to a single factory. Fees typically scale with SKU count and complaint volume.
• Route 3 (own subsidiary). Right for brands with material Japan revenue, multiple Japan distribution channels, or strategic reasons to own the regulatory relationship directly. Up-front cost is the subsidiary setup (see article above) and the MAH licence; ongoing cost is the statutory officer staffing.

MAH licence application essentials

Whether for a subsidiary or a third-party service provider, the licence application includes:

• Applicant entity registration (法人登記) and tax registration.
• Designated principal place of business (本社) and any warehousing locations — each location may need its own accessory licence.
• Statutory officer appointments with proof of qualification — typically a Japanese pharmacist licence or equivalent qualifying training and experience for the General Marketing and Quality Assurance Manager role.
• GVP / GQP standard operating procedures (SOPs) covering quality assurance, complaint handling, recall procedures, and safety reporting.
• Application form filed with the prefectural pharmaceutical affairs division; processing typically 2–4 months after the application is complete.

Practical points for foreign brands

• Plan the MAH question before the OEM contract.The MAH choice affects the OEM contract's recall, QA agreement, and label-change provisions. Negotiating the OEM contract first and then trying to layer in MAH responsibilities afterwards usually requires rework.
• Statutory officer recruitment is the long-pole.Qualified candidates for the General Marketing and Quality Assurance Manager role are a known bottleneck in the Japanese regulatory labour market. Plan 3–6 months of recruiting time for an own-subsidiary route, or use a third-party MAH for immediate launches.
• Imported cosmetics MAH is a separate categoryfrom domestic-manufacture MAH. If the buyer plans to import fully finished goods from outside Japan alongside Japanese OEM production, the MAH application must cover both scopes.