Opening a pharmacy: what the structural-facility standards and the managing pharmacist require

In short: to open a pharmacy (a dispensing pharmacy) you must obtain, for each shop, a pharmacy opening licence from the prefectural governor with jurisdiction over its location (in cities and special wards with a public health centre, the mayor or ward head) under the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices, Article 4(1). The main requirements are three: (1) the structural facilities conform to the standards of the Regulation for the Structure and Equipment of Pharmacies; (2) the system for dispensing and selling medicines conforms to the standards; and (3) the applicant does not fall under a ground for disqualification (Article 5). A pharmacy must place a managing pharmacist to manage it in person, and the managing pharmacist may not, in principle, concurrently engage in pharmaceutical practice as a business at a place other than that pharmacy (Article 7(3)). This article organises the requirements and flow as general information; the pharmaceutical-affairs counter decides whether a licence is granted, and our office does not guarantee that outcome.

What do the structural-facility standards for a pharmacy opening licence require?

The Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (Act No. 145 of 10 August 1960; the former Pharmaceutical Affairs Act; hereinafter the "Pharmaceuticals and Medical Devices Act"), Article 4(1), provides that a pharmacy may not be opened without the licence of the prefectural governor with jurisdiction over its location (the mayor or ward head where the location is in a city or special ward with a public health centre). This licence lapses unless renewed every six years (Article 4(4)).

Whether a licence can be granted is set out in Article 5, and it may be refused where any of the following applies: (1) the structural facilities do not conform to the standards set by ordinance of the Ministry of Health, Labour and Welfare (item 1); (2) the system for conducting dispensing and the sale or provision of medicines does not conform to the standards set by ministerial ordinance (item 2); or (3) the applicant falls under a ground for disqualification such as revocation of a licence or a criminal penalty (item 3). The ministerial ordinance that sets the structural-facility standards is the Regulation for the Structure and Equipment of Pharmacies (Ordinance of the Ministry of Health and Welfare No. 2 of 1 February 1961). The main items its Article 1 sets are as follows.

Item	Main content	Basis
Area	An area of roughly 19.8 square metres or more, able to conduct the pharmacy's business appropriately	Regulation for the Structure and Equipment of Pharmacies, Article 1(1)
Ventilation and cleanliness	Sufficient ventilation and cleanliness	Same
Ceiling, floor, inner walls	A structure easy to clean and preventing dust from accumulating	Same
Storage equipment	Cool-and-dark storage equipment, and lockable storage equipment (for poisons, psychotropics, etc.)	Same
Dispensing room	An area of 6.6 square metres or more, with ceiling and floor of boarding, concrete or the like, and measures so that persons receiving dispensed medicines cannot enter	Same
Dispensing equipment	Equipment and instruments necessary for dispensing	Same
Information-provision facility	A facility for providing drug information and pharmaceutical guidance	Same

Concrete figures for the area, the layout, and the treatment of the waiting area and display shelves differ in detail among prefectures and cities with a public health centre in their review criteria and guides. As nationwide figures, the "roughly 19.8 square metres or more" and the "dispensing room of 6.6 square metres or more" are set in the Regulation, but the actual conformity judgement rests with the review by the pharmaceutical-affairs counter of the opening area. The legality of the premises' own use and structure (its use classification under the Building Standards Act, and building confirmation where a change of use is involved) is not within our office's judgement; it is confirmed by an architect and the specified administrative agency. Selection and lease of the business premises are handled by Yotsuba Real Estate Co., Ltd., while our office handles preparation of the licence application.

Must the managing pharmacist be full-time and exclusive? Are concurrent posts allowed?

A pharmacy places a pharmacist who manages it in person (the managing pharmacist). The Pharmaceuticals and Medical Devices Act, Article 7(1), provides that where the pharmacy opener is a pharmacist, the opener must manage the pharmacy in person (unless a manager is designated from among other pharmacists engaged at the pharmacy to manage it); Article 7(2) provides that where the opener is not a pharmacist, a manager must be designated from among pharmacists engaged at the pharmacy to manage it in person. In other words, even where a company is the opener, the in-person management of the pharmacy is done by a pharmacist manager.

Whether concurrent posts are allowed is set by Article 7(3). The pharmacy's manager must not be a person who engages "as a business" in the management of a pharmacy or other pharmaceutical practice at a place other than that pharmacy. However, this does not apply where the manager has obtained the permission of the prefectural governor for the location of the pharmacy. Accordingly, a managing pharmacist is in principle required to be engaged exclusively at one pharmacy, and a concurrent post at another shop is limited to the exceptional case of the prefectural governor's permission. The thinking on this concurrent-post permission is organised in the Ministry of Health, Labour and Welfare's notice "On the thinking about permission for concurrent posts of the manager of a pharmacy provided in Article 7(3)" (Yakusei-so-hatsu No. 320003 of 20 March 2019). The word "full-time" is not a term of the statute but is used in administrative practice; confirm the specific treatment of working hours and days with the counter of the opening area.

The manager must, so as not to risk harm to public health, supervise the pharmacists and other staff working at the pharmacy, manage the structural facilities and medicines and other goods, exercise necessary care, and state necessary opinions in writing to the pharmacy opener (Article 8). The acquisition of an individual pharmacist's licence and the propriety of individual dispensing are not the subject of this article. The working conditions, social insurance and work rules of pharmacists and employees are handled by Yotsuba Labour and Social Security Attorney Office (labour and social security attorney).

What is the application flow for a pharmacy opening licence, and what documents are needed?

The application proceeds working back from the planned opening date. The standard flow is: (1) prior consultation with the pharmaceutical-affairs counter (the prefecture's pharmaceutical-affairs section or the public health centre) → (2) confirming whether the premises and design conform to the structural-facility standards → (3) filing the pharmacy opening licence application → (4) document review → (5) on-site inspection (confirming the structural facilities) → (6) licence → (7) opening. How many days before the planned opening date to file, and the schedule of the on-site inspection, differ by municipality, so starting from prior consultation is the safe route.

Typical documents required for the application are as follows. Because forms, copies and attachments differ by municipality, confirm them in the official guide of the opening area.

Document	Outline
Pharmacy opening licence application	Name, location, outline of structural facilities, name of the manager, etc.
Outline and floor plan of the structural facilities	Positions and dimensions of the dispensing room, waiting area, storage equipment, information-provision facility, etc.
Vicinity map	A drawing showing the pharmacy's location
Copy of the managing pharmacist's licence and documents showing the employment relationship	For the pharmacist who will be the manager
Certificate of registered matters, articles of incorporation, etc.	Where the opener is a company
Medical certificate, etc.	On the grounds for disqualification of the applicant (for a company, the officers conducting the business) (depends on the municipality)

A point to note here is that designation as an "insurance pharmacy," which lets you dispense under public medical insurance, is a procedure separate from the pharmacy opening licence. Insurance-pharmacy designation is applied for separately, under the Health Insurance Act, to the head of the Regional Bureau of Health and Welfare with jurisdiction over the location. Even with an opening licence, you cannot dispense under insurance without insurance-pharmacy designation. Preparation of the opening-licence application and the like is handled by an administrative scrivener, and our office does not guarantee whether the licence or the insurance-pharmacy designation is granted.

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How does a pharmacy differ from store-based sales (drugstores, etc.) in its licence?

"Shops that sell medicines" divide broadly into pharmacies and store-based sales businesses, and the licence that is the basis differs. A pharmacy is a facility that has obtained the pharmacy opening licence under the Pharmaceuticals and Medical Devices Act, Article 4; it may dispense, and may handle pharmacy medicines (including prescription medicines), designated Class-1 medicines and general medicines. By contrast, a store-based sales business is a business that has obtained the licence under Article 26; it may not dispense and may not handle pharmacy medicines (prescription medicines, etc.). What it may handle are designated Class-1 medicines and general medicines. A so-called drugstore may operate as a store-based sales business if it does not dispense; where it sets up a dispensing room and also dispenses, a pharmacy opening licence is required.

The qualification of the manager also differs. In a store-based sales business, a shop selling designated Class-1 medicines or Class-1 medicines has a pharmacist as its shop manager, while a shop selling only Class-2 and Class-3 medicines may have a pharmacist or a registered seller as its manager (Article 28). A pharmacy needs a pharmacist manager. Also, unless it is a pharmacy, the word "pharmacy" may not be used in its name (Article 6).

	Pharmacy	Store-based sales business
Basis	Pharmaceuticals and Medical Devices Act, Article 4 (opening licence)	Same Act, Article 26 (licence)
Dispensing	Allowed	Not allowed
Medicines it may handle	Pharmacy medicines (incl. prescription), designated Class-1, general	Designated Class-1, general (pharmacy medicines not allowed)
Manager	Pharmacist	Pharmacist (where selling designated Class-1/Class-1) / registered seller (Class-2 and Class-3 only)
Name "pharmacy"	May be used	May not be used (Article 6)

Because opening a pharmacy crosses several fields, the roles are divided as follows.

• Preparation of the pharmacy opening licence application and support for prior consultation with the pharmaceutical-affairs counter → Yotsuba Administrative Scrivener Office (administrative scrivener)
• Selection, lease and important-matters explanation of the business premises → Yotsuba Real Estate Co., Ltd.
• Working conditions, social insurance and work rules of pharmacists and employees → Yotsuba Labour and Social Security Attorney Office (labour and social security attorney)
• Legality of the building's use and structure, and building confirmation where a change of use is involved → an architect and the specified administrative agency
• Accounting and tax of the medicine-sales business → a tax accountant
• Individual legal judgement on rights, obligations and disputes → an attorney

Yotsuba Administrative Scrivener Office and Yotsuba Real Estate Co., Ltd. are separate businesses. Our office handles only support for the pharmacy opening licence as an independent business, and premises, labour and tax are contracted or consulted separately with each qualified professional and business. Our office receives no referral fee. For the whole picture of licensing, see Licensing and Permits; for the flow of engagement, see Engagement Flow; and for fees, see Fee Schedule. On the opening notification of a clinic under the Medical Care Act, see Opening notification of a clinic (Medical Care Act, Article 8); and on the incorporation approval of a medical corporation, see The flow of incorporation approval of a medical corporation. Whether the licence is granted is itself decided by the pharmaceutical-affairs counter.

FAQ

Q. If I have a pharmacist's licence, can I open my own pharmacy right away?
A. The licence and the opening licence are separate. A pharmacist's licence is a personal qualification, but to open a pharmacy you must, separately from the licence, obtain a pharmacy opening licence for each shop from the prefectural governor (mayor or ward head in a city/ward with a public health centre) (Pharmaceuticals and Medical Devices Act, Article 4(1)). The licence requires conformity with the structural-facility and system standards and that you do not fall under a ground for disqualification (Article 5).

Q. Can a managing pharmacist hold a concurrent post at another pharmacy or shop?
A. In principle no. A pharmacy's manager must not be a person who engages as a business in pharmaceutical practice at a place other than that pharmacy (Pharmaceuticals and Medical Devices Act, Article 7(3)). However, where the manager obtains the permission of the prefectural governor for the location of the pharmacy, a concurrent post is exceptionally allowed. The thinking on the permission is shown in the Ministry's notice (Yakusei-so-hatsu No. 320003 of 20 March 2019).

Q. Are a drugstore and a dispensing pharmacy the same licence?
A. They are different licences. A pharmacy that dispenses has the pharmacy opening licence (Article 4); a shop that does not dispense and sells designated Class-1 and general medicines has the store-based sales licence (Article 26). They differ in whether dispensing is allowed, the range of medicines that may be handled, and the manager's qualification (pharmacist or registered seller). If you set up a dispensing room and also dispense, you need a pharmacy opening licence.

Q. Once I get a pharmacy opening licence, can I dispense under insurance right away?
A. No. Designation as an insurance pharmacy, which lets you dispense under public medical insurance, is a procedure separate from the opening licence; it is applied for under the Health Insurance Act to the head of the Regional Bureau of Health and Welfare. Only after obtaining the opening licence and then the insurance-pharmacy designation can you dispense under insurance. Confirm the order and required documents with the Regional Bureau of Health and Welfare and the pharmaceutical-affairs counter.

Sources (Primary Information)

• e-Gov Law Search, "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices" (Act No. 145 of 10 August 1960), Article 4 (opening licence; renewal every six years), Article 5 (licensing standards), Article 6 (the name of a pharmacy), Article 7 (management of a pharmacy), Article 8 (the manager's duties), Article 26 (store-based sales licence), Article 28 (shop manager) (accessed 2026-09-24)
• e-Gov Law Search, "Regulation for the Structure and Equipment of Pharmacies" (Ordinance of the Ministry of Health and Welfare No. 2 of 1 February 1961), Article 1 (structure and equipment of a pharmacy) (accessed 2026-09-24)
• Ministry of Health, Labour and Welfare, "On the thinking about permission for concurrent posts of the manager of a pharmacy provided in Article 7(3) of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices" (Yakusei-so-hatsu No. 320003 of 20 March 2019) (accessed 2026-09-24)
• The application forms, review criteria and guides for the pharmacy opening licence published by the pharmaceutical-affairs counter of the prefecture, city with a public health centre or special ward with jurisdiction over the planned site (standards for structural facilities, area and system; required documents; accessed 2026-09-24)

This article is general information and does not guarantee the grant of an individual pharmacy opening licence, conformity with the standards for structural facilities and system, or insurance-pharmacy designation. The review, on-site inspection and grant decision are made by the pharmaceutical-affairs counter (prefecture, city with a public health centre, or special ward), and insurance-pharmacy designation is made by the Regional Bureau of Health and Welfare. Concrete standards such as the area and the layout are in part delegated to each municipality's review criteria and guides, so confirm them on the official page of the opening area. The legality of the building's use and structure, and building confirmation where a change of use is involved, are handled by an architect and the specified administrative agency. Selection, lease and important-matters explanation of the business premises are handled by Yotsuba Real Estate Co., Ltd. (a separate business); working conditions, social insurance and work rules of pharmacists and employees by Yotsuba Labour and Social Security Attorney Office; accounting and tax by a tax accountant; and individual legal judgement on rights, obligations and disputes by an attorney, each as an independent business under a separate contract or consultation. Our office receives no referral fee. Individual judgements are made by a qualified professional after a meeting. Written by Joji Uramatsu, administrative scrivener and licensed real estate broker.