Latvia Pharmaceutical Licensing

This guide is limited to human medicines. Compounding, manufacture, import and distribution of medicines are pharmaceutical activities requiring a special authorisation or registration; pharmacy retail, wholesale and manufacture/import are three separate pathways. A general pharmacy may be established by a practising pharmacist, pharmacists in joint practice or a capital company. A company-operated pharmacy must satisfy either the requirement for pharmacists to hold at least 50% of the shares or for certified pharmacists to make up at least half of the board. These pharmacy-specific rules must not be extended to infer uniform foreign-investment, capital or company-form restrictions for wholesale or manufacturing businesses.

— Veterinary medicines are separately regulated by the Food and Veterinary Service and EU veterinary-medicines rules; human-medicine authorisations cannot be applied directly.

For medicinal products for human use, the Ministry of Health is responsible for policy, while SAM handles pharmaceutical enterprise licensing, re-registration, manufacturing/import/wholesale compliance assessments and medicine registration; the Health Inspectorate supervises manufacturing and distribution. The current Cabinet Regulation No. 410 was published on 1/7/2025. SAM’s English-language service pages may still display the former Regulation No. 800; submissions should follow No. 410 and the forms confirmed by SAM. SAM’s public register can be used to check licensed enterprises and suspended licences, but it cannot replace item-by-item checking of licence annexes.

— The Pharmacists’ Association is responsible for the individual registration of pharmacists and pharmacy assistants working in pharmacies.

General pharmacies retail to the public; closed pharmacies distribute only within healthcare institutions. Both require a special authorisation from SAM. Prescription medicines may be dispensed only against a prescription or a written request from an institution as provided by law. A new general pharmacy or a relocated pharmacy must first apply for a site decision. SAM makes the site decision within five working days, and the authorisation application must be submitted within 60 days after a positive decision. Controlled drugs, pharmacy compounding, online sales of non-prescription medicines, veterinary-medicine sales and 24-hour operation must be approved and specified as special conditions in an annex to the authorisation.

— The manager of a general pharmacy must be a pharmacist holding a pharmacist professional qualification certificate; pharmacy personnel must also complete individual registration.

Local wholesalers apply to SAM for a wholesale authorisation, declare their storage, distribution and control sites, and demonstrate compliance of their premises, equipment, personnel, documentation and GDP responsible person. SAM conducts an on-site compliance assessment within 30 days of receipt. GDP requires a documented quality system, an appointed responsible person, training, suitable secure premises, temperature control and segregation, approval of suppliers/customers, and recall arrangements. Companies holding a wholesale or manufacturing authorisation in an EU/European Economic Area home country that enter Latvia to conduct wholesale activities must submit their authorisation, translations, branch, GDP responsible person and recall information to SAM, and may begin only after receiving a positive decision.

— A wholesale authorisation does not automatically cover manufacture, repackaging/labelling or imports from third countries.

All or partial manufacture, manufacture of medicinal products for research, and importation of finished medicinal products from outside the EU/EEA require a SAM manufacturing or import licence; a manufacturing licence is also required even if the products are intended solely for export. The application should specify the products, dosage forms/categories, operations, manufacturing/quality-control sites, premises, equipment, personnel, and qualified persons permanently available. SAM conducts a compliance assessment within 60 days of receipt. GMP applies to manufacture, control and import, covering the quality system, personnel, premises and equipment, documentation, production, quality control, outsourced activities, recalls and self-inspection.

— Products within the scope of the licence may be distributed wholesale; products, dosage forms, sites or operations not specified may not automatically be handled.

A general pharmacy is managed by a person holding a pharmacist's professional qualification certificate. Pharmacists and pharmacist assistants working in pharmacies must be registered with the Latvian Pharmacists' Association and undertake recognised continuing education. Changes to registration information must be reported within 15 working days; the Association must decide within 30 days at the latest after receiving complete documentation. Persons with non-EU/EEA qualifications that have been recognised must work under a pharmacist's supervision for at least one year before practising independently in a pharmacy. Wholesalers must have a GDP responsible person; manufacturers/importers must have at least one qualified person continuously available. Individual registration does not replace an enterprise licence.

— Changes to key personnel may also trigger supplementation of the enterprise licence information or re-registration.

A licence is valid only for the pharmaceutical activity address and premises specified in the application. A pharmacy must have suitable premises, equipment, personnel and documentation; a general pharmacy must also meet requirements for commissioning public buildings and accessibility for customers. Under GDP, wholesale premises must be suitable, secure, clean and dry, temperature-controlled and support segregation. Manufacturing premises, technical equipment and quality-control capability are assessed against GMP and the proposed activities. The legislation does not establish universally applicable minimum thresholds for floor area, capital or equipment models.

— Pharmacies should keep floor plans and internal procedures on site; descriptions of manufacturing premises should be updated to reflect actual activities.

Applications and supporting documents prescribed by SAM must be submitted for manufacturing/import, wholesale and pharmacy activities. SAM conducts an initial review in order of receipt and checks document completeness within five working days; applicants are asked to provide missing documents. Wholesale documentation focuses on the site, floor plan/right of use, equipment, personnel appointments and GDP arrangements; manufacturing/import applications also require details of the manufacturing premises, products/operations, quality-control sites and qualified persons. For a new general pharmacy or relocation, obtain a site decision first, then submit the licence application.

— Check each application attachment for consistency across “business—product—site—personnel—quality system”.

Under Cabinet Regulation No. 410, the state fees are: €284.57 for a general pharmacy in a city, €42.69 for a general pharmacy outside a city, €426.86 for wholesale, €711.44 for medicinal product/API manufacture, and €284.57 for medicinal product importation; re-registration is 10% of the corresponding state fee. Additional fees for document review, compliance assessment and other services are payable under SAM's fee schedule for paid services. Decisions on manufacturing/import and wholesale licences must be made within 90 days at the latest; manufacturing/import re-registration is generally decided within 30 days, with exceptions of up to 90 days. Statutory time limits are suspended while additional information is awaited. Regular licences have no fixed term, but a special pharmacy operated by a pharmacist assistant has a five-year term.

— A pharmacy site decision is made within five working days; this guide does not present that as a fixed approval period for a full pharmacy licence.

Licence holders must operate within the scope of the licence and its annexes, at approved premises and in compliance with statutory quality requirements, maintain records of medicinal products/controlled substances received and supplied, and submit to inspections. Manufacturing/import and wholesale operators must undergo the relevant GMP/GDP compliance assessment within three to six months after commencement or a prescribed significant re-registration; pharmacies and wholesalers are reassessed at least once every three years. Where major deficiencies are identified, a manufacturing/import applicant must submit a corrective action plan within 10 days of receiving the report; continued non-compliance may result in suspension or revocation.

— A licence with no fixed term does not remove the obligations relating to inspections, records, quality systems and change control.

Changes to information on a licence or its annexes cannot be assumed to synchronise automatically with company registration. Minor or temporary changes specified in the Regulation are generally added to the file within 10 working days; other changes, particularly changes to the pharmacy manager, GDP responsible person or qualified person, require an application for re-registration within five working days of the change. A new site, new product category/dosage form, contract manufacturer or quality-control contractor, and significant changes to premises, equipment, personnel or documentation require re-registration and a compliance assessment. The materials reviewed contain no general rule that a licence is automatically transferred upon a sale of shares.

— A general pharmacy transaction must also continue to meet the pharmacist ownership or certified-pharmacist board requirements.

An enterprise operating licence is not a product marketing authorisation. As a general rule, a medicinal product may be placed on the market or distributed only if it is registered in Latvia and entered in the national register of medicinal products, or authorised under the EU centralised procedure; an unregistered medicinal product generally requires a separate SAM authorisation. Importation of finished medicinal products from outside the EU/EEA follows a separate manufacturing/import licensing route. Each import or export of narcotic or psychotropic medicines listed in Schedules II and III of Latvia requires SAM authorisation; exports must also be accompanied by authorisation from the importing country where required by its law.

— Enterprise licences, product authorisations, third-country import arrangements, controlled-drug authorisations and individual pharmacist registration must each be verified independently.