Fees

 
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.

The state fee has to be paid for each application. For initial MA application and for renewal application, the single form should be submitted for each strength and pharmaceutical form.

In case of variation applications where grouping is accepted, one single application form will be submitted. The state fee has to be paid for submitting the application, irrespective of how many variations are listed on the application form

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.

A person who has paid a state fee has the right to request the refund of the state fee from the State Agency of Medicines if the paid amount exceeds the prescribed amount, if the state fee was paid for an act the performance of which was not requested, if the state fee was paid by the person who is exempt from payment of the state fee, the person withdraws the application before the application is reviewed or the application for performing the act is not reviewed. A claim for refund of a state fee expires two years as of the end of the year of payment of the state fee.

The application for refund are required with original signature or digital signature and shall consist following data:

1. Name and surname of the applicant and personal identification code or name of the legal person and registration code;
2. Bank details and the account from which the state fee has been paid;
3. Date of the payment;
4. Bank details and the account where the state fee has been paid to;
5. Name of the performance of which the request the refund of the state fee is applied, the amount of the requested state fee and the legal ground for refund;
6. Bank details and the account where state fee should be refunded (bank, account no, name of the owner of the account, personal identification code or registration code, also SWIFT and IBAN if applicable).

State Agency of Medicines verifies the data of submitted application and makes the decision during 30 days after receiving correct application for refund.

Medicinal products for human use or veterinary medicinal products: assessment fees for marketing authorisation applications of decentralised procedures and mutual (and subsequent) recognition procedures where Estonia is participating as the Member State concerned (CMS):

Medicinal products for human use: assessment fees for marketing authorisation applications of national and decentralised procedures where Estonia is participating as the reference Member State (RMS). Where an applicant for a marketing authorisation requests that Estonia participate in the decentralised marketing authorisation procedure or marketing authorisation procedure of mutual recognition as a reference country, the amount of 14 000 euros is added to the assessment fee (according to the Medicinal Products Act § 67(2)):

Veterinary medicinal products: assessment fees for marketing authorisation applications of national and decentralised procedures where Estonia is participating as the reference Member State (RMS). Where an applicant for a marketing authorisation requests that Estonia participate in the decentralised marketing authorisation procedure or marketing authorisation procedure of mutual recognition as a reference country, the amount of 14 000 euros is added to the assessment fee (according to the Medicinal Products Act § 67(2)):

In the event of a repeated marketing authorisation procedure of mutual recognition and, upon renewal of a marketing authorisation in the event of decentralised marketing authorisation procedure or marketing authorisation procedure of mutual recognition in which Estonia participates as a reference country, the amount of 3000 euros is added to the assessment fee (according to the Medicinal Products Act § 67).

* The assessment fee for variations is charged for every separate variation. All strengths and/or pharmaceutical forms of a certain product are considered the same marketing authorisation in the context of variation applications.

** VNRA annual fee is charged for every separate marketing authorisation valid last year.

*** The assessment fee for Worksharing is charged for every separate application/procedure.

An invoice will be sent to the marketing authorisation holder by 15 March of the calendar year following the year for which the fee is calculated.

No payment of the fee should be made in advance. Please note that the bank charges should be paid by the applicant.

*Regulatory advice and advice to a licensed health service provider, an independent research institution or a professional organisation of doctors (if the sponsor does not receive any financial or other remuneration from the manufacturer of the investigational medicinal product or its representative) shall be free of charge.

Payment should be made according to the invoice. No payment should be made in advance.

When the State Agency of Medicines evaluates CTA that is submitted on the basis on Directive 2001/20/EC, the evaluation fees are the following:

1. Initial CTA 2690€;
2.  Substantial amendment 2490€.

Evaluation fees of an application for a clinical trial of a medicinal product.

Payments should be made according to the invoice. No payments should be made in advance.

The documentation concerning the marketing authorisations for human and veterinary medicinal products should be submitted electronically only.

State Agency of Medicines encourages the applicants to use CESP (Common European Submission Portal) for submission of marketing authorisation documentation.

We accept all types of submissions for marketing authorisations for human and veterinary medicinal products via CESP: national and MRP/DCP new applications, renewals, variations, response documents, PSURs for veterinary medicinal products, ASMFs etc.

There is no size limit for CESP submissions.

If the applicant cannot use CESP the following ways of submissions are accepted:

• Via email (if < 10 MB) or Eudralink (if < 200 MB per one file) to the e-mail address

[email protected]: applications, responses and additional documentation for marketing authorisation, renewal and variations via national and MRP/DC procedure.

[email protected]: translations of final product information for MRP/DC procedures (initial, renewal, variations)

• On CD/DVD to postal address: 1 Nooruse Str, 50411 Tartu, Estonia

Only one way of submission must be used. Sending double submissions leads to confusion and will delay processing of the application.

Centralised Procedure applications must not be submitted to the State Agency of Medicines. Further guidance can be found here.

PSUR submission

Submitting PSURs for veterinary medicinal products

PSURs for veterinary medicinal products should be submitted via CESP or to the e-mail address [email protected]. For submissions larger than 10MB please use CESP (preferred) or send 1 CD/DVD to postal address: 1 Nooruse Str, 50411 Tartu, Estonia.

Submitting PSURs for human medicinal products

All PSURs for human medicinal products must be submitted electronically via eSubmission Gateway / Web Client to the PSUR Repository. Information regarding PSUR Repository is available on the EMA eSubmission website.

Referral submissions for human medicinal products

The use of the Common Repository for human Referral submissions is mandatory for all NCAs since 1st of December 2017. Additional copies should not be submitted directly to the NCAs on CD/DVD or via CESP as this might lead to validation issues and cause delays. Information regarding Common Repository is available on EMA eSubmission website.

Requirements for eSubmission

State fees: The state fee has to be paid prior to the submission of the application and the proof of payment should be enclosed.

Samples: The applicant is not required to submit the sample of the medicinal product with the MA application. One sample has to be presented when the medicinal product is actually launched.

Assessment fees: An invoice on the assessment fee will be sent within 10 days after acceptance of the application for processing. The applicant shall pay the fee within 40 days after presentation of the invoice.