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LexorCorp Global Order

Guide

Licence for procuring and processing human cells, tissues and organs in Estonia

In Estonia, procuring human cells, tissues or organs from a donor, and processing them (testing, preserving, storing and distributing them), each needs an activity licence from the State Agency of Medicines (Ravimiamet).

LexorCorp Global OÜ · published 11 November 2026

In short

In Estonia, procuring human cells, tissues or organs from a donor, and processing them (testing, preserving, storing and distributing them), each needs an activity licence from the State Agency of Medicines (Ravimiamet) 9 13 . The applicant must have a documented quality system, a named competent or responsible person with the qualification the act sets, and suitable premises and equipment 19 20 21 . This page summarises what the act requires, which documents go with the application, the state fees and the statutory time limit.

Order the application documents: Order

In Estonia, procuring human cells, tissues or organs from a donor, and processing them (testing, preserving, storing and distributing them), each needs an activity licence from the State Agency of Medicines (Ravimiamet)913. The applicant must have a documented quality system, a named competent or responsible person with the qualification the act sets, and suitable premises and equipment192021. This page summarises what the act requires, which documents go with the application, the state fees and the statutory time limit.

Information as of 11 November 2026. Every numbered statement of this page was checked in the official text named below and re-checked by a second reviewer on 2026-11-10. The page is general information, not legal advice; the authority decides on every application.

What the activity is

The Estonian act separates three activities. Procurement covers in particular selecting the donor, removing the material, and coding, packaging, labelling and releasing it1. Processing (käitlemine) covers describing, coding, labelling, testing, preserving and treating the material, and packaging, labelling, storing, releasing and distributing it2. Transplantation is the therapeutic transfer of material removed from a donor3.

The act does not cover: the transplantation of reproductive cells and embryos within the meaning of the Artificial Insemination and Embryo Protection Act (reproductive-cell donors remain subject to the act and to that Act's extra rules); blood under the Blood Act; cells, tissues and organs removed from a person and transplanted back to the same person in one surgical procedure; and research use other than medical use in a human being4.

The legal act and the authority

The act is the Cells, Tissues and Organs Procurement, Processing and Transplantation Act (rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus), in the redaction in force from 1 January 20245. It implements Directive 2004/23/EC on quality and safety standards for human tissues and cells6. Detailed procurement and processing rules are set by a regulation of the responsible minister7. General rules on activity licences come from the General Part of the Economic Activities Code Act (MSÜS)8.

The competent authority is the State Agency of Medicines (Ravimiamet): it decides on the licence9 and supervises procurement and processing10. The Health Board (Terviseamet) supervises transplantation10. Licences are recorded in the register of activity licences of the State Agency of Medicines, and the agency enters cell and tissue licences in the EU register of tissue establishments, where each holder receives a unique identification number11.

From 7 August 2027 Directive 2004/23/EC is repealed and Regulation (EU) 2024/1938 on substances of human origin applies12; the Estonian act may change before then.

Who must apply

An activity licence is required for procuring cells, tissues and organs and for processing cells, tissues and organs13. The act limits who can hold these licences:

  • a procurer is a provider of specialised medical care that holds a procurement licence14;
  • a processor of cells or tissues is a legal person in private law that holds a processing licence; organs may be processed only by a provider of specialised medical care with an organ processing licence15;
  • a person applying for procurement and processing licences at the same time must also hold a licence for specialised medical care under the Health Services Organisation Act16.

For transplantation, the health care provider must hold a specialised medical care licence under the Health Services Organisation Act17. Importing cells or tissues from outside the EU and the European Economic Area (EEA) additionally needs an import certificate from the State Agency of Medicines18.

Requirements for the applicant

  • Quality system. Procurers and processors must develop a quality system that meets good practice in the European Union, fully documented and monitored at all stages19, with the resources to run it: competent staff, suitable premises, equipment and materials20.
  • Competent person (processing). The processor appoints a natural person responsible for processing each type of cell, tissue or organ21. For cells or tissues, this person needs a university degree in medicine, biology or a related field and at least two years' experience in processing cells and tissues22. For organs, a completed residency or a medical specialty and at least two years' experience in processing organs22.
  • Person responsible for procurement. The procurer appoints a natural person responsible for procurement21. For cells or tissues: higher education in medicine, biology, nursing or midwifery and experience in procurement or special training provided by the procurer; for organs: a completed residency or a medical specialty23.
  • One establishment per person, qualified deputy. The same person cannot be the competent or responsible person at several processors or procurers at once, and the deputy must meet the same requirements24.
  • Ongoing duties. Procedures must follow internationally recognised or scientifically justified methods25; material may be released only to persons entitled to receive it25; traceability information is kept for at least 30 years and safety and quality records for ten years26; serious adverse events and reactions are reported to the State Agency of Medicines without undue delay27; and an annual report is due to the agency by 1 April28.
  • Capital, AML/CFT, seat. Whether a minimum capital or anti-money-laundering requirements apply is specified for the client's situation; the licence entitles the holder to operate at the place of business stated on it29.

Supervision takes place at least once every two years30. The act provides for a fine of up to €32,000 for a legal person31.

Documents filed with the application

Besides the general data required by MSÜS32, every application includes33:

  • Premises: proof of the right to use the premises; floor plan and description of the premises.
  • Procedures: description of the biovigilance system; description of the waste management arrangements.
  • Other items: the further items the act lists for every application.

A processing application adds, separately for each type of cell, tissue or organ34: among other items the act lists, a description of the processor's quality system and a copy of the radiation practice licence.

A procurement application adds the data of the person responsible for procurement, with responsibilities and deputising arrangements35.

State fee and processing time

State fees under the State Fees Act36:

  • processing licence application: €1,700;
  • procurement licence application: €665;
  • amending a processing licence: €640 or €320, and a procurement licence: €255 or €130, depending on the change;
  • import certificate application: €680.

The State Agency of Medicines decides on granting or refusing the licence within 60 days of the application9. The agency may require additional data and set a reasonable time to provide it37; under MSÜS the time limit runs from the submission of all required data38. An import certificate is issued within 30 days of submission of all required data and documents39. These are the law's time limits, not a promise of when or whether a licence will be granted.

What LexorCorp Global OÜ does and how to order

This activity is covered by the general row Activity licence application documentation, from €3,500 (fee for the standard scope); no VAT is added40. The service includes40:

  • the requirements of the act for the activity, from its official text, checked against your business;
  • the application and the documents it needs, drafted and assembled;
  • the written follow-up of the authority's questions.

Conditions: this is application preparation, not legal advice, audit or tax advice. The State Agency of Medicines decides — a licence, a date or a decision cannot be promised. The state fee is separate and paid by the company. The starting price is for one licence of ordinary scope; more work is agreed in writing before it starts40.

Order: order form

Sources

  1. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 2(1) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  2. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 2(2) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  3. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 2(3) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  4. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 1(3) p 1-4; § 10(7) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  5. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus, header — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  6. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus, footnote 1 — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  7. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 22(3) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  8. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 27(2); MSÜS § 16 — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  9. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 27(1) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  10. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 42(1)-(3) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  11. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 26(5)-(7) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  12. https://eur-lex.europa.eu/legal-content/EN/TXT/ Regulation (EU) 2024/1938 Art. 85, 87 — text in force from OJ L, 2024/1938, 17.7.2024
  13. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 26(1) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  14. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 2(10) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  15. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 2(11) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  16. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 26(2) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  17. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 26(3) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  18. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 38(1^1) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  19. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 22(1) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  20. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 22(2) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  21. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 23(1)-(2) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  22. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 24(1),(3) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  23. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 24(2),(4) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  24. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 23(3)-(4) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  25. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 20(1) p 3-4 — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  26. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 22(4) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  27. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 35(6) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  28. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 20(2) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  29. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 26(4); whole text checked (§§ 20-29), no capital or AML provision — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  30. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 42(4) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  31. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 47(2) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  32. MSÜS § 19(2) p 1, § 15(1) — text in force from 01.09.2025 (RT I, 02.01.2025, 26)
  33. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 27(2) p 1-11 — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  34. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 27(3) p 1-11 — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  35. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 27(4) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  36. Riigilõivuseadus §§ 284, 284^1, 285, 285^1, 285^2 — text in force from 01.11.2026 (RT I, 21.10.2026, 10)
  37. MSÜS § 19(6) — text in force from 01.09.2025 (RT I, 02.01.2025, 26)
  38. MSÜS § 20(1) — text in force from 01.09.2025 (RT I, 02.01.2025, 26)
  39. Rakkude, kudede ja elundite hankimise, käitlemise ja siirdamise seadus § 38(1^5) — text in force from 01.01.2024 (RT I, 06.07.2023, 75)
  40. LexorCorp Global price list and service description (price list)

Official sources

The laws this article names, each linked to its official text, as read on 9 October 2026. For the Estonian acts we read the English translation in Riigi Teataja; the legally binding text is the Estonian one.

Sources in the text are named without links; the official texts are linked under Official sources. To see which of our services your company needs, open the Business Navigator.

Order the application documents

We prepare the application documents and manage the process; the authority decides. Not legal advice.

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