Japan Pharmaceutical Licensing

This entry covers human medicinal products only. Pharmacy dispensing, placement sales, veterinary medicines, medical devices and regenerative medicine products are subject to separate systems; PMDA states that veterinary medicines fall under the Ministry of Agriculture, Forestry and Fisheries. [1]

The marketing authorisation holder is responsible for quality and post-marketing safety management, the manufacturing site for manufacturing, and the seller for sales at licensed premises. Importing products for marketing also requires checks on the Japanese marketing authorisation holder, product status and customs clearance. [1] [2]

The official materials reviewed did not confirm a nationwide minimum capital requirement, a prescribed company form or a general cap on foreign shareholding, so these are not listed as conditions. An overseas manufacturer's designation of a Japanese marketing authorisation holder is a product market-access arrangement, not a general prohibition or restriction on foreign investment.

— Determine the product classification first.

— Then distinguish premises, manufacturing, marketing and import activities.

— Confirm requirements individually for multiple shops, multiple locations or controlled products.

The Pharmaceuticals and Medical Devices Act and its Cabinet and ministerial orders form the national framework. The Ministry of Health, Labour and Welfare's forms page lists separate procedures for marketing authorisation holders, manufacturing, product approval, shop-based sales and wholesale sales. [1]

PMDA conducts scientific reviews of products; it also states that enquiries about marketing authorisation holder licences and wholesale licences should be directed to the prefecture where the business premises are located. The actual contact offices for retail, wholesale and some manufacturing matters vary by location. [2]

— Ministry of Health, Labour and Welfare: rules, forms and policies.

— PMDA: reviews and related inspections.

— Local authorities: licensing of premises within their jurisdiction.

Shop-based sales licences are issued for each shop and cover medicinal products requiring guidance and over-the-counter medicinal products. Applications must specify the applicant, shop, structural facilities and equipment, and sales arrangements, and include a floor plan and management personnel details. [1]

This licence does not permit the sale of pharmacy-only medicinal products, nor is it equivalent to permission to establish a pharmacy or dispense prescriptions. A registered seller's examination and individual registration cannot replace the shop premises licence. [1] [2]

— Apply separately for each shop.

— Sell within the approved scope.

— Check dispensing or controlled products separately.

Wholesale sales licences are issued for each business premises. Sales are limited to legally specified recipients such as pharmacies, marketing authorisation holders, manufacturers, other sellers, hospitals and clinics; retail sales to the public are not permitted. [1]

In principle, each business establishment must be managed by a pharmacist; an exception applies only where it sells solely items specified by ministerial ordinance as not requiring pharmacist management. Tokyo's new application page lists layout plans, corporate information, documentation on the manager's relationship with the applicant and qualifications, and states that an on-site investigation follows the application. This is a local example. [1] [2]

— Restrict customers to the legally permitted categories.

— Provide a manager and compliant facilities at each business premises.

— Check cold chains, shared warehouses and special product categories separately.

Manufacturing is prohibited without a manufacturing licence. Licences are issued for each manufacturing site, with structural facilities and equipment subject to assessment. New licences and renewals may be subject to documentary or on-site investigations; a change or addition of categories requires prior permission. [1]

Medicinal product manufacturing licences are normally valid for 5 years; manufacturing licences for pharmacy preparations are valid for 6 years. Tokyo's guidance lists categories including general manufacturing, sterile manufacturing and packaging / labelling / storage only. For applicable products, GMP conformity is linked to product approval. [2] [3]

— Determine the licence category according to the manufacturing processes.

— First check the site, equipment and manufacturing manager.

— Obtain a separate marketing authorisation holder licence and product approvals.

A shop manager must be a pharmacist or registered seller; wholesale business premises must in principle be managed by a pharmacist. In principle, a pharmacist must serve as manufacturing manager at a manufacturing site, while the marketing authorisation holder must separately appoint personnel responsible for quality and post-marketing safety management. Each requirement has limited statutory exceptions. [1]

Registered sellers are subject to an individual examination and registration system. The Ministry of Health, Labour and Welfare separately lists forms for registration applications, changes to register entries and reissuance of certificates. Individual registration differs from premises licensing and does not itself establish the right to work in Japan or qualification for all business activities. [2]

— Appoint personnel for each premises.

— Verify licences, registrations and restrictions on concurrent appointments.

— A distributor cannot automatically assume the marketing authorisation holder's responsibilities.

Licences cover specific sites: shops for retail, business premises for wholesale, and manufacturing sites for manufacturing. Shop applications involve structural facilities and equipment, sales arrangements and layout plans; wholesale and manufacturing facilities must also meet their respective standards. [1]

Manufacturing facility standards vary by process and category. The materials reviewed do not publish universal figures for floor area, floor level or storage capacity applicable to all sites, so no floor-area rules are listed.

— Plans must reflect actual movement flows.

— Wholesale premises may be subject to on-site investigation.

— Seek confirmation before alterations or relocation.

First complete classification and separate the business activities, then confirm the appropriate contact point with the local authority. The Ministry of Health, Labour and Welfare lists separate forms for shop sales, wholesale, manufacturing, marketing, product approval, minor changes and foreign-manufactured products. [1]

Tokyo's wholesale application procedure is a local example: it requires an application form, layout plan, corporate information and manager information, followed by an on-site investigation. PMDA states that product approval-related forms must be submitted in Japanese; this requirement must not be extended to all local documents without verification. [2] [3]

— Obtain the latest local checklist.

— Prepare premises, product and customs clearance documents separately.

— Allow time for investigation and supplementary submissions.

Sales business licences are renewed every 6 years; manufacturing licences generally every 5 years, and licences to manufacture pharmacy preparations every 6 years. Licence validity periods are not the same as those for product approval, GMP status or controlled medicine licences. [1] [2]

There is no nationwide initial application fee or processing time that can safely be generalised. Tokyo lists a new wholesale licence fee of 34,100 yen for some areas under its jurisdiction; Aichi Prefecture lists a renewal fee of 12,300 yen and standard processing periods of 14 or 19 days. These are local examples only. [3] [4]

— Sales business: renewal every 6 years.

— Manufacturing business generally: renewal every 5 years.

— Confirm current fees and timescales for the location concerned.

Sales businesses must renew on schedule and maintain their actual premises, manager, licence category and notified status. Manufacturing sites must retain manufacturing, testing and other records for at least 3 years or until 1 year after product expiry, whichever is longer; products to which GMP applies must comply with it. [1]

Tokyo's guidance also states that marketing authorisation holders and manufacturers should enter into a quality agreement before manufacturing, specifying processes, quality control, release and communication on changes. PMDA guidance for overseas manufacturing sites states that GMP conformity is a condition of product approval and that periodic inspections may take place. [1] [2]

— Sales businesses must maintain premises and management.

— Manufacturers must maintain records and GMP compliance.

— Marketing businesses must maintain quality and safety management.

The Ministry of Health, Labour and Welfare lists separate forms for sales business changes, suspension/discontinuation/resumption, manufacturing and marketing business changes, partial product changes, minor change notifications and succession to approvals; premises, companies and products are not covered by the same change procedure. [1]

Tokyo is a local example only: for wholesale businesses, conversion from an individual to a corporation, a change of operator, relocation or complete refurbishment requires a new licence; rebuilding or relocation of a manufacturing site or a change of its operator also requires a new licence. Changes to specified manufacturing particulars must be notified within 30 days after the change. For other areas, consult the relevant contact point separately. [2] [3]

The effects of share transactions, mergers or business transfers must not be assumed to include automatic licence transfer or to leave licences unaffected as a matter of course; before the transaction, separately check premises licences, marketing licences and succession to product approvals.

— Separate changes to the entity, premises, personnel, facilities and products.

— Confirm whether notification, licence amendment, renewal or a new licence is required.

— Set regulatory conditions precedent for the transaction.

In principle, approval for the marketing of medicines is obtained for each product. The applicant must hold the corresponding marketing licence, the manufacturing site must hold a manufacturing licence or foreign manufacturer accreditation, and the product must satisfy quality, efficacy, safety and applicable quality management requirements. [1]

Commercial imports are not automatically covered by retail or wholesale licences. The Kanto-Shinetsu Regional Bureau of Health and Welfare states that, when importing approved, certified or notified medicines and related products for marketing purposes, the business licence and product documents must be presented at each customs clearance; commercial sales also require business licences and approval for each product, among other requirements. [2]

A qualified Japanese marketing entity may be designated for products manufactured overseas. Narcotics, psychotropic substances, stimulant raw materials and similar products are subject to separate import, export, manufacturing, wholesale and retail requirements, as well as case-specific permits/notifications; rules for carrying products for personal use are not a commercial route. [3] [4]

— Check approval and manufacturing site status for each product.

— Check the importer, documents and port procedures for each consignment.

— Follow separate dedicated procedures for controlled products.