Kyrgyzstan Pharmaceutical Licensing

National rules require licences for the manufacture, wholesale and retail of medicines, valid nationwide. No separate local-level licensing system at the national level was identified; the staffing and floor-area exceptions for remote locations are provided for under national regulations. General application documents distinguish between legal entities, natural persons and individual entrepreneurs, but company/individual registration is not a pharmaceutical activity licence.

— Foreign ownership, minimum capital, specific company forms and uniform restrictions on business scope have not been verified.

The Ministry of Health is the competent authority for pharmaceutical activity licences listed in the directory. The Law on the Circulation of Medicines No. 13 of 2024 and the national procedure for medicine registration are legal instruments at the product level and are not equivalent to a business licence.

— Department of Medicines and Medical Devices: imports of controlled substances from third countries.

— Ministry of Justice database: current legislation portal.

Retail sale of medicines must comply with GPP. An ordinary pharmacy must have personnel with higher pharmaceutical education; a pharmacy in a remote location may, under the regulations, use personnel with secondary pharmaceutical education or medical personnel who have completed additional training in retail sale. The minimum area for an ordinary pharmacy is 35 square metres, divided into 15 for sales, 10 for storage and 10 for administrative and staff facilities; a remote-location pharmacy dispensing finished medicines must have a minimum area of 20 square metres.

— A pharmacy outlet in a medical building: 12 square metres.

— Other pharmacy outlets: 20 square metres; a pharmacy kiosk: 12 square metres.

— Each additional site must be entered in the licence register.

Wholesale of medicines must comply with EAEU GDP and be staffed by personnel with higher pharmaceutical education. The specific application documents are a GDP quality manual and temperature mapping records for the storage premises; a GDP compliance certificate must be obtained within six months after the licence is issued.

— From 2025, a valid GDP compliance document is checked.

— No uniform minimum warehouse area for wholesale of medicines has been identified.

A manufacturing application must include a sanitary and epidemiological conclusion for the site, a list of products proposed for manufacture, a site dossier stating the area, location and adjacent areas, and an undertaking to give prior notification before series production. The premises must comply with sanitary rules and EAEU GMP; from 2026, a valid GMP compliance certificate is checked.

— A certified authorised person and at least two personnel with the prescribed higher education qualifications are required.

— No uniform manufacturing area, capital or foreign investment restrictions have been identified.

The application must include evidence of qualified personnel, such as education documents, certification documents and employment records. Additional personnel requirements differ for retail, wholesale and manufacturing; the readable text of the Regulation does not specify individual independent-practice registration, recognition of foreign qualifications or a fixed staffing ratio.

— Retail: generally, personnel with higher pharmaceutical education.

— Wholesale: personnel with higher pharmaceutical education.

— Manufacturing: an authorised person and two personnel with the prescribed education qualifications.

The application must demonstrate ownership or another lawful basis for using the premises, buildings and equipment, and include a technical passport for the premises showing the business layout. Pharmacy floor-area requirements, wholesale temperature mapping and manufacturing GMP are requirements at different levels and must not be conflated.

— Newly added facilities are entered in the licence register.

— No uniform area requirement for wholesale/manufacturing has been verified.

The general package includes the application, identity or entity-registration documents, proof of payment of the fee, authorisation (if applicable), a list of documents and activity-specific materials. The competent authority reviews the materials and may conduct a pre-licensing inspection; documents may be retrieved through electronic interconnection. The directory indicates that applications for pharmaceutical activity licences may be submitted in person or online.

— For wholesale, also prepare the quality manual and temperature mapping records.

— For manufacturing, also prepare the site conclusion, site dossier and production list.

The general Regulation sets a decision period of 30 calendar days from registration of the application for issuance or refusal, and five working days for reissuance; pharmaceutical activity licences are valid indefinitely. The electronic directory lists a fee of 1,000 soms for legal entities and 500 soms for individuals, but the same page states 30 working days and retains a link to old legislation, so these details must be rechecked at the time of submission.

— Indefinite validity does not exempt the licence holder from ongoing compliance.

— Do not promise a fixed timeline or total cost.

Licence holders must continue to maintain the required premises, equipment and personnel conditions; manufacturers must maintain a GMP certificate, wholesalers a GDP certificate, and retailers must comply with GPP. Three violations, failure to rectify after a warning, false documents or violations that endanger safety may lead to suspension; reinstatement may be requested after an inspection confirms rectification.

— Manufacturing: GMP certificate checked from 2026.

— Wholesale: GDP certificate checked from 2025.

Licences are non-transferable. Corporate restructuring, a change of name, a change in an individual’s name, and corporate reorganisation require reissuance; an application must be made within 15 working days of the event, and the decision period is five working days. New persons must be entered in the register. The readable provisions do not establish a blanket conclusion as to whether an ordinary share transfer or change of address requires reissuance.

— A share transaction must not be described as an automatic transfer of the licence.

National registration of medicines is a separate product-level matter. This review confirms only the legal and procedural entry points; the complete readable text was not obtained, so the registration pathway, exemptions, timelines and fees are uncertain. The electronic catalogue lists import and export of ordinary medicines as separate items. Importation from third countries of narcotic drugs, psychotropic substances and precursors requires a separate permit from the Department of Medicines and Medical Devices; the catalogue indicates a validity period of one year.

— A business licence does not automatically constitute product registration or import/export rights.

— Rules for controlled substances must not be substituted for the rules on importing ordinary medicines.