Opening a drugstore in Japan: the store-sales permit, premises standards and the registered seller

To open a drugstore selling Class 2 and Class 3 drugs you need a store-sales-business permit from the prefectural governor under the Pharmaceuticals and Medical Devices Act. This guide covers how it differs from a dispensing pharmacy, the premises standards, who may sell which class, and ongoing duties.

In short: to open a drugstore that sells Class 2 and Class 3 drugs, you need a store-sales-business permit from the prefectural governor for each store (Article 24(1) and Article 26 of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc.). This is a separate system from the opening permit for a dispensing pharmacy; a store-sales business can operate with a pharmacist or a registered seller.

Updated and sources checked: 13 October 2026. This article organises premises and staffing checks from property selection onward. The formal name of the Act is the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc. (薬機法). Prefectural and Ministry of Health, Labour and Welfare guidance was retrieved, but the current consolidated statutes, final amendment numbers and complete commencement histories for the Act, its regulations and the premises regulation were not obtained or reconciled and remain unverified. The authority and qualified professionals assess individual permit compliance.

Does a drugstore need a "pharmacy" or a "store-sales" permit?

The first point is whether you dispense. Article 24(1) provides that no one may sell or deliver drugs as a business unless they are a pharmacy founder or hold a drug-sales-business permit. Under Article 25, the drug-sales-business permit is divided into store-sales, distribution-sales and wholesale. A drugstore selling to customers over the counter is a store-sales business.

Under Article 26, the store-sales permit is granted for each store by the prefectural governor for the store's location (in cities and special wards with a public health centre, the mayor or ward head is the point of contact). By contrast, dispensing against prescriptions requires a pharmacy opening permit, which presupposes management by a pharmacist.

Type of store	Permit needed	Staffing premise	Basis
Dispenses (handles prescriptions)	Pharmacy opening permit	Pharmacist (managing pharmacist)	Article 4 etc.
Sells OTC drugs without dispensing	Store-sales-business permit	Pharmacist or registered seller	Article 24(1), Article 26

A store-sales business may handle designated-use drugs and OTC drugs (Class 1, 2 and 3) but not prescription (medical) drugs. Because the system changes depending on whether you co-locate dispensing, confirm with the prefectural pharmaceutical-affairs section when deciding the format. The dispensing pharmacy permit is covered in the pharmacy permit: premises and managing pharmacist; if you also sell medical devices such as contact lenses, see selling or leasing highly controlled medical devices.

How far do the store-sales premises standards go?

One permit requirement is the premises. Article 26(4)(i) provides that a permit may be withheld where the store's premises do not meet the ministerial standard (Article 2 of the Regulation on Structure and Equipment of Pharmacies, etc.). In general, the premises must be adequately ventilated and clean, store and display drugs separately from other goods, and — where designated-use or Class 1 drugs are handled — have equipment for information provision and display equipment that customers cannot directly touch (such as a lockable fixture).

Article 26(4)(ii) also requires that the system for selling and delivering drugs meets the standard (Article 2 of the system ordinance). Both the premises (the box) and the sales system (the people) are reviewed.

Item to confirm	Example basis
Ventilation, cleanliness, lighting	Article 2 of the premises regulation
A place to store and display drugs separately from other goods	Same article
Information-provision and display equipment for designated-use/Class 1	Same article
Sales system (staffing across opening hours)	Article 26(4)(ii), system ordinance Article 2

Numeric standards for area and partitioning and attachment forms differ by municipality. For a leased property, the key points are whether you can secure sales and storage sections and prepare the store floor plan and location sketch to attach. This article does not give fixed area or equipment figures (they vary by municipality, and the current consolidated text of Article 2 of the premises regulation was not obtained, so they remain unverified).

For which class is a registered seller or a pharmacist required?

A store-sales business must, under Article 28, place a person who manages the store in practice (the store manager), and the store manager is a pharmacist or a registered seller as provided by ministerial ordinance. Who may sell depends on the class of drug.

Article 36-9 requires Class 2 and Class 3 drugs to be sold or delivered by a pharmacist or registered seller engaged in sales at the store. Designated-use drugs and Class 1 drugs are sold by a pharmacist. A registered seller is a person who has passed the examination under Article 36-8 and obtained the prefectural sales-engagement registration.

Class	Who may sell
Designated-use and Class 1 drugs	Pharmacist
Class 2 and Class 3 drugs	Pharmacist or registered seller

For stores handling Class 1 or designated-use drugs, the guidance shows that a pharmacist is in principle the store manager (per the prefectural review criteria). How you staff pharmacists and registered sellers against your classes and opening hours is directly tied to the property's size and your hiring plan. Shift and social-insurance design are the domain of a labour and social security attorney.

Who files the permit, and who checks the premises structure?

Who to engage	Scope
四葉行政書士事務所	Preparing store-sales permit documents (assisting the applicant's own filing)
四葉不動産株式会社	Selecting the store property; preliminary checks on zoning and building rules; viewing brokerage
Labour and social security attorney	Employment, work rules and social-insurance design for pharmacists and registered sellers
Pharmacists and other qualified persons	Judgements on handling drugs and providing information

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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. You contract with each field's provider separately as an independent business, and each provider bills and receives payment directly. Our office receives no referral fee. The prefectural pharmaceutical-affairs section is the administrative point of contact for permits, not a party engaged under a professional-services contract.

See permits and licensing support, the engagement process and the fee schedule. We assist with property selection and preliminary viewing checks, but the final judgement on whether the premises meet the standard is made by the authority receiving the application.

What continues to be required after opening?

A permit is not the end. Under the store manager's management, the store-sales business keeps a system for information provision and responding to consultations appropriate to the classes handled. At the storefront it posts the items required by law, such as the permit category and matters about the manager and the pharmacists and registered sellers on duty (the posted items are set in the enforcement regulation; the specific article numbers were not obtained from the current consolidated text and remain unverified).

Under Article 26, the store-sales permit lapses with the passage of time, and continuing requires renewal (guidance commonly states the permit's term is six years; the consolidated text of the provision setting the term was not obtained and remains unverified). A change of manager, a change in the number of staff, or a structural change to the store may trigger a notification or change procedure. Confirm what counts as a change procedure in the receiving authority's latest guidance.

FAQ

Q. Can I open a drugstore without a pharmacist?
A. For a store-sales business selling mainly Class 2 and Class 3 drugs without dispensing, you may place a pharmacist or a registered seller as the store manager (Article 28). But if you handle designated-use or Class 1 drugs, a pharmacist sells them, and the guidance shows a pharmacist is in principle the manager. The required person changes with the class handled.

Q. What is the difference between a pharmacy permit and a store-sales permit?
A. A pharmacy presupposes dispensing against prescriptions and requires management by a pharmacist. A store-sales business is a permit to sell designated-use and OTC drugs without dispensing, and can operate with a pharmacist or a registered seller. The governing provisions, staffing requirements and premises are a separate system.

Q. If I only sell online, do I not need a store?
A. Even for specified sales of OTC drugs (such as online), a store-sales permit based on a physical store is the premise, and rules specific to specified sales for display and information provision apply. There are conditions on the classes and methods you may handle, so confirm with the receiving authority.

Q. How long does the permit take, and what does it cost?
A. The application fee is set by prefectural ordinance and regulation, and the amount differs by municipality. The standard processing period is shown in each municipality's review criteria. It depends on whether the documents and the store (premises and system) are ready. This article does not give fixed amounts or days (the variation is large and we have not verified them, so they remain unverified).

Sources (Primary Information)

e-Gov: Pharmaceuticals and Medical Devices Act: Article 24(1) (sales-business permit), Article 25 (types of sales-business permit), Article 26 and Article 26(4)(i)/(ii) (store-sales permit and premises/system standards), Article 28 (store management), Article 36-8 (registered-seller examination), Article 36-9 (who sells Class 2 and Class 3 drugs). Current consolidated text and commencement history were not obtained (unverified).
e-Gov: enforcement regulation: procedures for store-sales posting, specified sales and sales-engagement registration. The current consolidated text for the specific article numbers was not obtained (unverified).
Regulation on Structure and Equipment of Pharmacies, etc. (1961 Ministry of Health and Welfare Ordinance No. 2), Article 2 (store-sales premises). Confirm numeric standards and attachment forms in the receiving authority's latest guidance.
Shizuoka Prefecture: permit for the drug-sales business (store sales): Article 26(4)(i) (premises regulation Article 2), (ii) (system ordinance Article 2), (iii) (disqualifications), six-year renewal (referenced 2026-10-13).
Saitama City: store-sales permit application: Article 24(1) and Article 26; the note that a pharmacist is the manager for designated-use/Class 1 (referenced 2026-10-13).
MHLW: handling of the registered-seller system (31 March 2023, Yakusei-hatsu 0331016): Article 28(3) (store-manager requirements), Article 36-8(1) (registered-seller examination), sales-engagement registration (referenced 2026-10-13).

Updated and retrieved 2026-10-13. Article numbers are limited to what the public guidance and MHLW notice confirm. e-Gov consolidated provisions have not been treated as retrieved. Specific premises figures, the article numbers for posted items, fees and standard processing periods remain unverified; publication is held pending qualified review.

This is general information and does not guarantee the grant of an individual permit, a store manager's eligibility, premises conformity, or processing time or cost. Judgements on handling drugs and information provision are made by qualified professionals such as pharmacists, and the final decision on a permit is made by the competent authority. Written by Joji Uramatsu, administrative scrivener and licensed real-estate transaction specialist.