Company profile · Tartu, Estonia

State Agency of Medicines Estonia

Medicines Regulation, Medical Device Oversight, GMP Licensing, and Pharmacovigilance · National medicines and devices authority

Verified 15 Mar 2026 · 3 sources

EstoniaRegulatory anchorTartu

Estonia's medicines-control node governing licensing, vigilance, device supervision, and regulated market access.

Contact & location
Lead
Katrin Kiisk (verified ↗)
Compliance
Not yet on record
Last reviewed
15 Mar 2026 (3mo ago)
Scale
National medicines and devices authority
Capabilities
Medicines authorisation · Manufacturing and wholesale licensing · Pharmacovigilance oversight
Founded
1991
Headcount
51-200
Site and address
Clinical profileSTATUS: VERIFIED MARCH 2026

Katrin Kiisk

Director General

Check official leadership source
Full addressNooruse 1, 50411 Tartu, Estonia
Site coordinatesVerification evidence is still being completed.
Review cycleMay 2026
Physical site source

Official Ravimiamet contact page listing Nooruse 1 in Tartu as the agency contact address.

Open source
Operating profile

National medicines and devices authority

Tartu, Estonia. Medicines Regulation, Medical Device Oversight, GMP Licensing, and Pharmacovigilance. Review completed on 15 Mar 2026.

2026 technical specializationMedicines Regulation, Medical Device Oversight, GMP Licensing, and Pharmacovigilance
Core capabilities
Medicines authorisationManufacturing and wholesale licensingPharmacovigilance oversightMedical-device supervision
Governance

Estonian Ministry of Social Affairs and EU medicines regulatory framework

National medicines-control authority, EU regulatory enforcement

Editorial note

Medicines Regulation, Medical Device Oversight, GMP Licensing, and Pharmacovigilance

Estonia's medicines-control node governing licensing, vigilance, device supervision, and regulated market access.

Related companies
Editorial note

Ravimiamet is the Estonian regulatory authority anchoring inspection control, licences, and market surveillance for the Tartu life-science layer.

FULL TRUST REVIEW COMPLETE
Shown only when all seven trust checks are fully mapped in the directory.
Current review cycleMarch 2026Last reviewed: 15 March 2026
Capabilities

Core capabilities

Primary declared technical activities and areas of operating focus.

Medicines authorisation
Manufacturing and wholesale licensing
Pharmacovigilance oversight
Medical-device supervision
Verification source dossier

Verification source dossier

Official source set used to support leadership, physical-site, certification, and watch-note evidence.

Leadership evidenceRavimiamet official agency overview confirming Katrin Kiisk as Director General.Source origin: ravimiamet.eeOpen source
Supporting evidenceRavimiamet public English agency surface for medicines-control scope.Source origin: ravimiamet.eeOpen source
Physical-site evidenceOfficial Ravimiamet contact page listing Nooruse 1 in Tartu as the agency contact address.Source origin: ravimiamet.eeOpen source
Infrastructure

Declared infrastructure

Licensing and inspection teams
Medical-device supervision systems
Estonian vigilance and authorisation platform
Regulatory posture

Quality system coverage

GMP / GLP / ISO-13485 / FDA-Inspected are global quality-system standards. "Verified active" means the directory confirmed the certification is current; "Review in progress" means the cert status is currently being re-verified.

GMP
REVIEW IN PROGRESS 2026
GLP
REVIEW IN PROGRESS 2026
ISO-13485
REVIEW IN PROGRESS 2026
FDA-Inspected
REVIEW IN PROGRESS 2026
Verification history

Verification history

15 Mar 2026: Executive identity confirmed via official management disclosure.
15 Mar 2026: Full trust review completed.
FAQ

Frequently asked questions

Where is State Agency of Medicines Estonia located?
State Agency of Medicines Estonia operates from Nooruse 1, 50411 Tartu, Estonia, Tartu, Estonia.
Who runs State Agency of Medicines Estonia?
State Agency of Medicines Estonia is led by Katrin Kiisk, Director General. Verified 15 Mar 2026.
What does State Agency of Medicines Estonia do?
Estonia's medicines-control node governing licensing, vigilance, device supervision, and regulated market access. Core capabilities: Medicines authorisation, Manufacturing and wholesale licensing, Pharmacovigilance oversight, Medical-device supervision.
Editorial context

Related technical briefs

Briefs that name Tartu as a covered market or city.