- About SAM
- Human medicines
- Marketing authorisation
- Drug information
- Clinical trials
- European Pharmacopoeia
- Pharmacovigilance
- Classification of medicinal products
- Statistics
- Manufacture, distribution, pharmacy
- Travelling with medicinal products
- The import and export of goods that require a special authorization
- Sending of medicinal products
- Advertising
- Marketing authorisation
- Veterinary medicines
- Department of Biologicals
- Blood handling
- Procurement and handling of cells, tissues and organs
- Biovigilance
- Application of cells, tissues and organs licence
- List of licensed procurers and handlers of cells, tissues and organs (tissue establishments)
- Legislation for procurement and handling cells, tissues and organs
- Special authorisation for import and export and notification of import and export of cells, tissues and organs
- Advanced therapies medicinal products
- The import and export of goods that require a special authorisation
- Legislation
- Supervision
- Laboratory
State fees and assessment fees
08.02.2019
The state fee has to be paid prior to the submission of the application and the proof of payment should be enclosed. Please note that the bank charges should be paid by the applicant.
The state fee has to be paid to the Ministry of Finance (Rahandusministeerium)
Address: Suur-Ameerika 1, Tallinn 10122, ESTONIA
Reference number: please choose the correct reference number from the table below.
| IBAN: | EE932200221023778606 |
| SWIFT code: | HABAEE2X |
| Bank: | Swedbank |
| Address: | Liivalaia 8, 15040 Tallinn, ESTONIA |
| IBAN: | EE891010220034796011 |
| SWIFT code: | EEUHEE2X |
| Bank: | SEB |
| Address: | Tornimäe 2, 15010 Tallinn, ESTONIA |
| IBAN: | EE701700017001577198 |
| SWIFT code: | NDEAEE2X |
| Bank: | Luminor Bank |
| Address: | Liivalaia 45, 10145 Tallinn, ESTONIA |
Activity licences for handling of medicinal products
| State fee (€) | Reference number | |
|---|---|---|
| Review of applications for activity licence | ||
| Manufacture of medicinal products (except packaging of herbal substances) | 1000.00 | 2900082281 |
| Manufacture of medicinal products - packaging of herbal substances | 150.00 | 2900082281 |
| Wholesale distribution of medicinal products | 1000.00 | 2900082281 |
| Retail pharmacy | 150.00 | 2900082281 |
| Hospital pharmacy | 150.00 | 2900082281 |
| Veterinary pharmacy | 150.00 | 2900082281 |
| Brokering of medicinal products | 150.00 | 2900082281 |
| Review of applications for amendments of information on the activity licence | ||
| Manufacture or wholesale distribution (amendment of site of activity) | 500.00 | 2900082281 |
| Manufacture - packaging of herbal substances (amendment of site of activity) | 60.00 | 2900082281 |
| Manufacture or wholesale distribution (changing the holder of the activity licence or the competent person or a change in the secondary conditions of the activity licence) | 150.00 | 2900082281 |
| Manufacture - packaging of herbal substances (changing of the holder of the activity licence or the competent person or a change in the secondary conditions of the activity licence) | 20.00 | 2900082281 |
| Pharmacy (amendment of site of activity or opening a new subsidiary) | 75.00 | 2900082281 |
| Pharmacy (changing of the holder of the activity licence or the competent person or a change in the secondary conditions of the activity licence) | 20.00 | 2900082281 |
| Amendment of the details of a permanent adress in an activity licence for brokering in medicinal products | 20.00 | 2900082281 |
| Review of applications for granting the right of distance sales of medicinal products to a retail pharmacy | 75.00 | 2900082281 |
Handling of narcotic drugs and psychotropic substances and their precursors
| State fee (€) | Reference number | |
|---|---|---|
| Issue or renewal of an activity licence for handling of drug precursors | 150.00 | 2900082281 |
| Application for an import or export authorisation of narcotic drugs and psychotropic substances | 10.00 | 2900082281 |
| Application for an import or export authorisation of drug precursors | 10.00 | 2900082281 |
Activity licence for procurement of cells, tissues and organs
| State fee (€) | Reference number | |
|---|---|---|
| Review of applications for activity licence | 665.00 | 2900082281 |
| Review of applications for amendments data of activity licence if the facilities of procurement are changed or added and if special conditions of the licence are changed or added | 320.00 | 2900082281 |
| Review of applications for amendments data of activity licence if owner of the activity licence is changed, responsible person is changed or the third party performing contract works related with procurement is changed or added and if there are changes in the procurement process due to procurement of infectious materials | 130.00 | 2900082281 |
Activity licence for handling of cells, tissues and organs
| State fee (€) | Reference number | |
|---|---|---|
| Review of applications for activity licence | 1700.00 | 2900082281 |
| Review of applications for amendments data of activity licence if the facilities of handling are changed or added and if special conditions of the licence are changed or added | 640.00 | 2900082281 |
| Review of applications for amendments data of activity licence if owner of the activity licence is changed, competent person is changed or the third party performing contract works related with handling is changed or added, if changes are to be made in ventilation system or water system of the handling facilities and if there are changes in the handling process and equipment due to handling of infectious materials | 320.00 | 2900082281 |
Marketing authorisation applications
| State fee (€) | Reference number | |
|---|---|---|
| Issue or renewal of marketing authorisation application (human medicinal product) | 32.00 | 2900082294 |
| Application for variation both type I and II to a marketing authorisation (human medicinal product) | 16.00 | 2900082294 |
| Issue or renewal of marketing authorisation application (veterinary medicinal product) | 32.00 | 2900082294 |
| Application for variation both type I and II to a marketing authorisation (veterinary medicinal product) | 16.00 | 2900082294 |
"Please note that the proof of payment should include at least the following data:
- the name of the product, pharmaceutical form and strength;
- the number and type of applications;
- reference number according to the type of application."
| State fee (€) | Reference number | |
|---|---|---|
| Clinical trial application (includes one research centre) | 385.00 | 2900082294 |
| For each additional research centre | 16.00 | 2900082294 |
Please note that the proof of payment should also include the EudraCT reference number.
Other fees
| Type of application | Price (€) |
|---|---|
| Complete application, fee per one human medicinal product | 1275 |
| Complete application, fee per one veterinary medicinal product | 958 |
| Abridged application, fee per product | 958 |
| Subsequent pharmaceutical form or strength containing the same active ingredient of the same future marketing authorisation holder | 511 |
| Licence for parallel import, per product and exporting country | 639 |
| Fee for traditional herbal medicinal product | 958 |
| Fee for homeopathic preparation | 958 |
| Additional fee to cover the participation of the State Agency of Medicines in the mutual recognition procedure or decentralised procedure as Reference Member State. | 14000 |
| Type of application | Price (€) |
|---|---|
| Fee per one medicinal product | 639 |
| Subsequent pharmaceutical form or strength containing the same active ingredient of the same future marketing authorisation holder | 383 |
| Fee for traditional herbal medicinal product | 383 |
| Fee for homeopathic preparation | 383 |
| Additional fee to cover the participation of the State Agency of Medicines in the repeat use procedure or renewal procedure in the mutual recognition or decentralised procedure as Reference Member State | 3000 |
| Type of application | Price (€) |
|---|---|
| Variation Type IB | 100 |
| Variation Type II | 383 |
| Additional fee to cover the participation of the State Agency of Medicines in the mutual recognition procedure or decentralised procedure as Reference Member State for type IB variations | 500 |
| Additional fee to cover the participation of the State Agency of Medicines in the mutual recognition procedure or decentralised procedure as Reference Member State for type II variations | 1000 |
An invoice will be sent upon receipt of the application. No payment of assessment fee should be made in advance. Please note that the bank charges should be paid by the applicant.
Fee for Monitoring the Safety and Quality of Medicinal Products
| Price (€) | |
|---|---|
| The fee for monitoring safety and quality of a medicinal product per marketing authorization | 160 |
| The fee for monitoring safety and quality of a medicinal product per marketing authorization if the State Agency of Medicines is acting as Reference Member State in the mutual recognition procedure or decentralised procedure or is the assessor of the PSUR for the active substance | 320 |
An invoice will be sent upon receipt of the application. No payment of assessment fee should be made in advance. Please note that the bank charges should be paid by the applicant.
The assessment fees of Clinical Trial Applications
| Application type | Price (€) |
|---|---|
| Clinical trial application | 383 |
| Variation to a clinical trial | 63 |
An invoice will be sent upon receipt of the application. No payment of assessment fee should be made in advance. Please note that the bank charges should be paid by the applicant.
| Name of the statistcal analysis | Price (€) |
|---|---|
| Sales of one ATC code divided by preparations | 30 |
| Estonian Statistics on Medicines, general report (1 year) | 1533 |
| Estonian Statistics on Medicines, general report (½ year) | 862 |
| Estonian Statistics on Medicines, general report (¼ year) | 511 |
| Estonian Statistics on Medicines, extended general report (1 year) | 1789 |
| Estonian Statistics on Medicines, extended general report (½ year) | 1022 |
| Estonian Statistics on Medicines, extended general report (¼ year) | 607 |
| Estonian Statistics on Medicines, full report (1 year) | 2045 |
| Estonian Statistics on Medicines, full report (½ year) | 1182 |
| Estonian Statistics on Medicines, full report (¼ year) | 703 |
| Other statistical analyses (cost per hour) | 40 |
Payments should be made according to the invoice. No payments should be made in advance.
State Agency of Medicines
