Medicines wholesale and manufacturing licence in Estonia

In Estonia, a company that sells medicinal products wholesale or manufactures them needs an activity licence from the State Agency of Medicines (Ravimiamet)⁹¹². The rules are in the Medicinal Products Act (ravimiseadus). This page sets out who needs the licence, the requirements, the documents, the state fee and the 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 2026-11-11. The page is general information, not legal advice; the authority decides on every application.

What the activity is

The Medicinal Products Act calls work with medicinal products "handling" (käitlemine): manufacturing, procurement, import and export, distribution, transport, storage and withdrawal from the market, with the related records and reports. Distribution includes wholesale¹.

Wholesale means importing, procuring, warehousing, storing, transporting and exporting medicinal products in order to sell or otherwise supply them wholesale². A wholesaler may sell only to holders of a pharmacy, manufacturing or wholesale licence, except where the Act names other buyers³. It may buy only from holders of a manufacturing, wholesale or pharmacy licence, and it may buy from a pharmacy only in the cases the Act names⁴.

Manufacturing means preparing medicinal and intermediate products, sterilisation, packaging, labelling, repackaging, relabelling, quality control and batch release⁵. Placing safety features on packs, or replacing them, is a manufacturing step that needs a licence⁶.

Not covered by this page:

• Pharmacies (separate licence, own page)⁹.
• Brokering of medicinal products (negotiating purchases or sales for someone else without physically handling the products). Brokering needs a separate activity licence⁷.
• Small quantities of a veterinary medicinal product supplied by one veterinarian to another, within the limits the Act sets. The Act does not count this as wholesale⁸.

The legal act and the authority

The main act is the Medicinal Products Act (ravimiseadus, RavS). Under the Act, an activity licence is needed to manufacture medicinal products, sell them wholesale, provide pharmacy services or broker medicinal products⁹. Only a manufacturing licence holder may manufacture¹⁰; only a wholesale or manufacturing licence holder may sell wholesale¹¹.

The competent authority is the State Agency of Medicines (Ravimiamet). It decides on the application¹² and acts as controller of its register of activity licences (tegevuslubade register), where the licence data are kept¹³. The agency also sends data on manufacturing and wholesale licences for medicinal products for human use to the Union database referred to in Article 111(6) of Directive 2001/83/EC. On its website, the agency names this database as EudraGMDP¹⁴.

The General Part of the Economic Activities Code Act (majandustegevuse seadustiku üldosa seadus, MSÜS) adds general licensing rules³⁴; the State Fees Act (riigilõivuseadus) sets the fee³⁹.

Who must apply

Anyone who sells medicinal products wholesale or manufactures them in Estonia must hold the matching licence⁹¹⁰¹¹. The holder may be a public authority or public-law legal person, a sole trader or a private-law legal person, but not a non-profit association (mittetulundusühing)¹⁵.

The Act names these main exemptions and limits:

• A pharmacy-service licence holder needs no manufacturing licence to prepare medicines in the pharmacy on prescription, or to divide medicines into dispensing packs¹⁶.
• A manufacturing licence holder may also sell wholesale¹¹. A company may otherwise hold a licence for only one field of activity. The exception is that a wholesale licence holder may also hold a manufacturing licence, and the other way round¹⁷.
• Each wholesale or manufacturing site needs its own licence. For wholesale, the site is the place where the medicinal products are stored. For a wholesale licence without the right to store, the site is the office¹⁸.

Requirements for the applicant

Ownership. A pharmacy licence holder, or its subsidiary, may not be a shareholder or member of a private legal person that holds a manufacturing or wholesale licence¹⁹. A wholesale or manufacturing licence holder may not provide veterinary services (with a narrow exception for animal blood products)²⁰.

Competent person. The licence holder appoints a competent person (pädev isik). In wholesale, this person ensures that the products sold meet the legal requirements and that the rules on handling, records and reporting are kept; for imports, the person also checks storage conditions in transport and that the packaging matches the marketing authorisation²¹²².

The competent person must hold the higher education and the work experience set by a regulation of the responsible minister²³. For a manufacturing site, the person's training and experience must match the manufacturing activities, and the deputy must meet the same requirements²⁴. A person may be the competent person at only one site at a time, except at manufacturing sites²⁵. A person who was the competent person at a site whose licence was revoked cannot be appointed again until two years have passed²⁵. A wholesaler's competent person may not work for a pharmacy-service licence holder at the same time²⁶.

Premises, quality system and good practices. The holder must:

• provide conditions for handling medicinal products that meet the legal requirements²⁷;
• run a quality system²⁷;
• give the competent person the means to do their duties²⁷;
• check that the safety features on packs are authentic and intact under Commission Delegated Regulation (EU) 2016/161²⁷;
• keep records and report to the agency²⁷;
• keep a permanent and adequate range of medicinal products and deliver quickly within Estonia²⁷.

Wholesale of medicinal products for human use must follow the good distribution practice guidelines²⁸. Manufacturing must follow the EEA good manufacturing practice²⁹. The responsible minister sets by regulation the detailed rules for wholesale and for manufacturing, including premises, equipment, staff and work organisation³⁰.

Capital and AML/CFT. AML/CFT means anti-money laundering and countering the financing of terrorism. Whether minimum capital or AML/CFT rules apply is specified for the client's case.

Documents filed with the application

The application is filed on the form for the licence concerned, published on the agency's website³². The agency accepts applications by e-mail or through its client portal³³. Besides the general data required by the MSÜS³⁴, the application contains the documents below.

For every licence³⁵:

• a document proving the right to use the premises;
• a plan and description of the premises;
• a description of the technical equipment;
• a description of how the medicinal products are stored;
• the organisation of quality control;
• the company name.

Additionally for wholesale³⁶:

• an organisation chart;
• the groups, pharmaceutical forms or products to be handled;
• a list of active substances for human medicinal products to be imported or distributed;
• a description of transport arrangements;
• the planned total number of staff, and the number of specialists;
• if the applicant has no storage conditions of its own, a copy of the relevant contract.

Additionally for manufacturing³⁷:

• products and processes: the list of product groups, process scheme, sterilisation methods;
• equipment: equipment list, validation and calibration;
• organisation: contract manufacturers, batch release, organisation chart;
• building: ventilation and water systems;
• the further items listed in RavS § 46 (3).

The licence lists the wholesale activities and product groups, and states whether the holder may handle narcotic and psychotropic substances³⁸.

State fee and processing time

The State Fees Act sets these fees for reviewing an application³⁹:

Changing the holder or the competent person on a manufacturing or wholesale licence costs EUR 500; on a licence for packaging herbal substances it costs EUR 150⁴⁰.

The agency decides whether to grant or refuse the licence within 60 days after the application is filed¹². The agency's website counts the 60 days from the submission of all required documents³³. The agency may ask for additional data, and it sets a reasonable deadline for them⁴¹. This time limit is set by law and is not a promise. The licence is granted only if the applicant meets the requirements⁴².

What LexorCorp Global OÜ does and how to order

LexorCorp Global OÜ offers this under its service "Activity licence application documentation", at a price from €3,500 (one-time). LexorCorp Global OÜ is not registered for VAT, so no VAT is added. The state fee and other official costs are paid by the client.

The service covers:

• setting out the requirements of the Medicinal Products Act for the client's activity, based on the official text;
• preparing the application documents;
• filing the application with the State Agency of Medicines;
• written follow-up on the agency's questions.

The service does not include legal advice, an audit or tax advice. LexorCorp Global OÜ does not promise that the licence will be granted, a date, or any decision of the authority.

To order, use the request form at order form.

Sources

1. RavS § 3 lg 1–2 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
2. RavS § 26 lg 3 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
3. RavS § 26 lg 4 (other buyers: § 26 lg 5–7, § 27, § 28) — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
4. RavS § 26 lg 8 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
5. RavS § 16 lg 2 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
6. RavS § 16 lg 3 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
7. RavS § 3 lg 4; § 38 lg 1 p 4 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
8. RavS § 26 lg 3¹ — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
9. RavS § 38 lg 1 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
10. RavS § 16 lg 1 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
11. RavS § 26 lg 1 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
12. RavS § 46 lg 1 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
13. RavS § 39 lg 2–3, 6 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
14. RavS § 38 lg 4¹; Ravimiamet 'Activity licences' — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
15. RavS § 41 lg 1 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
16. RavS § 16 lg 4 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
17. RavS § 42 lg 1–2 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
18. RavS § 40 lg 1, 3 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
19. RavS § 42 lg 3 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
20. RavS § 43 lg 1 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
21. RavS § 12 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
22. RavS § 54 lg 4–5 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
23. RavS § 53 lg 5–6 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
24. RavS § 53 lg 3 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
25. RavS § 53 lg 1, 2 p 1 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
26. RavS § 43 lg 5 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
27. RavS § 44 lg 1 p 1, 1¹, 2, 2⁶, 4, 5 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
28. RavS § 26 lg 8¹ — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
29. RavS § 16 lg 7² — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
30. RavS § 26 lg 9 p 1; § 16 lg 8 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
32. RavS § 46 lg 2¹ — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
33. Ravimiamet 'Activity licences' — text in force from website, read 2026-11-11
34. MSÜS § 19 lg 2 — text in force from 01.09.2025
35. RavS § 46 lg 2 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
36. RavS § 46 lg 4 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
37. RavS § 46 lg 3 p 1–17 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
38. RavS § 50 p 2, 4 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)
39. RLS § 279 p 1, 1¹, 2, 3 — text in force from 01.11.2026 (RT I, 21.10.2026, 10); these points in force since 01.01.2025
40. RLS § 280 p 3, 4 — text in force from 01.11.2026 (RT I, 21.10.2026, 10)
41. MSÜS § 19 lg 6 — text in force from 01.09.2025
42. RavS § 47 — text in force from 01.10.2026 (RT I, 11.07.2026, 37)

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.

• State Fees Act — Riigi Teataja, English translation

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.