Kazakhstan Pharmaceutical Licensing

This guide covers only medicine retail, wholesale and manufacturing; it does not present medical services, financial licences or general Business Registration as pharmaceutical activity licensing. Current rules allow natural persons and legal entities to apply for pharmaceutical activity licences and annexes through eGov/eLicense. [Source: Pharmaceutical licensing service rules]

The application form for legal entities includes fields for foreign legal entities, branches or representative offices; this does not establish whether foreign investment access, company incorporation, tax or special sector restrictions exist or do not exist. These require separate verification.

— Pharmaceutical activity licence: the entity and selected subcategories.

— Premises: verify against the licence/annex and qualification requirements.

— Product registration, imports/exports and controlled substances: separate routes.

The Ministry of Health's Committee for Medical and Pharmaceutical Control regulates the circulation of medicines and medical devices; its territorial departments process pharmaceutical activity licences. The regulatory chain described by the Committee covers registration, import, storage, transport, sale and use, so business licensing alone must not be the sole focus. [Sources: Committee explanation; licensing rules]

— Committee: circulation regulation and good pharmaceutical practices.

— Territorial departments: licence and annex services.

— Specific facilities: territorial sanitary and epidemiological coordination may be required.

Pharmacy retail is a subcategory of pharmaceutical activity licensing. The educational and experience requirements for pharmacy heads/department heads and sales staff are set out in the Committee's territorial department explanation of qualification requirements. [Source: Explanation by the Committee's territorial department for Aktobe Region]

GPP covers receipt, storage, issue, personnel, SOPs, documentation, self-inspection and quality systems; it does not replace special restrictions on prescription medicines or controlled drugs.

— Submit details of the retail subcategory, premises and personnel.

— Online sales require suitable delivery equipment.

— Exceptions for rural personnel are limited to the circumstances listed by the authorities.

The Committee's explanation cites Article 233 of the Code: medicine wholesale is conducted at pharmacy warehouses by entities holding the corresponding licence; the notification route for medical device warehouses cannot replace a medicine wholesale licence. [Source: Committee explanation]

Medicine wholesale must comply with GDP to maintain quality during storage, transport and distribution and prevent falsified medicines from entering the supply chain.

— Warehouse heads: higher pharmaceutical education and three years' experience.

— Key storage and distribution personnel: higher or secondary pharmaceutical education.

— Submit details of warehouses, equipment, personnel and quality conditions.

The Committee cites Article 231 of the Code: domestic medicine manufacturing requires a licence obtained in accordance with the law and compliance with Kazakhstan and/or Eurasian Economic Union GMP; a manufacturing licence does not replace state product registration. [Source: Committee explanation]

For a GMP certificate, first apply for and schedule an inspection and rectify non-conformities, then apply for certificate issuance through eLicense.

— Production department heads: relevant higher education and three years' experience.

— Different educational requirements apply to quality control and equipment maintenance personnel.

— Prepare licensing, GMP and product registration as separate workstreams.

The qualification form requires details of personnel positions, education, professional experience and continuing education over the last 5 years. Conditions differ for pharmacies, pharmacy warehouses, manufacturing and compounding pharmacies and must not be applied interchangeably. [Sources: licensing rules; territorial guidance]

— Pharmacy: the person in charge generally requires pharmaceutical education and 3 years of experience.

— Warehouse: the person in charge requires higher education in pharmacy and 3 years of experience.

— Manufacturing: requirements differ for production, quality control and equipment roles.

The qualification form requires proof of ownership or lease of the premises/building, or trust management of state-owned assets, together with declarations of the address, floor area, equipment and conditions for storage, manufacturing and sale. [Source: licensing rules]

Pharmacies, warehouses and factories must be assessed separately according to their actual address, activities and product risks; sanitary and epidemiological coordination may apply to specified facilities.

— Pharmacy: organise receipt, storage and dispensing in accordance with GPP.

— Warehouse: manage storage, transport and distribution in accordance with GDP.

— Factory: prepare production and quality control in accordance with GMP.

Individuals or legal entities submit an application, qualification compliance documents and premises, equipment and personnel information to the Committee's territorial department via eGov/eLicense, using an electronic signature. [Source: licensing rules]

The authority registers the application on the same day and checks completeness within 2 days; following qualification review and licensing control, it electronically issues the licence/supplement or a reasoned refusal within 15 working days of registration.

— Select the subcategory and business address.

— Prepare the electronic signature, application and qualification documents.

— Track progress in the personal account and rectify deficiencies as notified.

Initial issuance of a licence and/or supplement takes 15 working days; reissuance takes 3 working days. Fees are payable under the Tax Code. [Source: licensing rules]

Territorial guidance specifies a licence fee of 10 MRP and a reissuance fee of 10% of the prescribed rate. MRP changes and should be checked on the electronic platform on the submission date. The licensing rules do not specify a uniform expiry or renewal provision for general licences.

— Initial licence/supplement: 15 working days.

— Reissuance: 3 working days.

— Import conclusion: 3 working days, free of charge, valid only within the calendar year of issue.

Qualification requirements continue to apply throughout the licence's validity, and the licensing authority may carry out post-issuance licensing control. [Source: licensing rules]

Manufacturers must maintain GMP compliance, wholesalers must maintain GDP compliance, and pharmacies must manage their quality systems, personnel, SOPs, documentation and self-inspections in accordance with GPP.

— Maintain the declared premises, equipment, personnel and quality conditions.

— Manufacturing: prepare for GMP inspections and rectification.

— Wholesale/retail: maintain GDP/GPP compliance respectively.

The rules specify circumstances requiring reissuance of a licence/supplement: changes to the licence holder's name, an individual enterprise's name/legal address, merger, conversion, absorption, division or separation of a legal entity, a legal entity's name/location, or the address of a facility specified in the licence. [Source: licensing rules]

Exceptions may apply to changes in place or street names resulting from administrative boundary changes; specified addresses may be updated through integration with state information systems. The reissuance service timeframe is 3 working days.

— Determine whether reissuance is triggered before a name or address change or restructuring.

— Merger, conversion, absorption, division and separation are expressly listed.

— No uniform answer has been verified for changes solely in shareholding/control.

State registration is the procedure by which medicinal products are authorised for domestic circulation and entered in the state register. Both domestically manufactured and imported medicinal products fall within its scope. Medicinal products that are unregistered or whose quality has not been confirmed through the statutory procedure must not be sold. [Source: Committee guidance]

Registered medicinal products are generally imported on the basis of register information; unregistered medicinal products or specified circumstances require an application for consent/a conclusion. This service normally takes 3 working days, and the conclusion is valid only within the calendar year of issue. Controlled substances follow a separate circulation licensing process.

— Product registration/dossier changes: separate from the operating licence.

— Import/export: assess according to registration status, origin and intended use.

— Controlled substances: separate licensing by subcategory, such as production, storage and transport.