Assessment fees
The assessment fees of Marketing Authorisation Applications for human medicines for national and mutual recognition procedure are the following:
| Type of application | EEK |
| Complete application, fee per product | 20 000 |
| Abridged application, fee per product | 15 000 |
| Subsequent pharmaceutical form or strength containing the same active ingredient of the same future marketing authorisation holder | 8 000 |
| Parallel imported or parallel distributed medicinal product, per product and exporting country | 10 000 |
| Fee for traditional herbal product | 15 000 |
| Fee for homeopathic preparation | 15 000 |
An additional fee of 100 000 EEK will be added to cover the participation of the State Agency of Medicines in the mutual recognition procedure or decentralised procedure as Reference Member State.
The assessment fees for Renewal of Marketing Authorisation Applications for national and mutual recognition procedure are the following:
| Type of application | EEK |
| Proprietary medicinal product | 10 000 |
| Same marketing authorisation holder’s each subsequent pharmaceutical form and strength containing the same active ingredient | 6 000 |
| Traditional herbal product | 6 000 |
| Homeopathic preparation | 6 000 |
The assessment fees of Variation Applications for national and mutual recognition procedure are the following:
| Type of application | EEK |
| Variation Type II | 6 000 |
Annual fee is 2500 EEK per marketing authorisation which was in force at least 6 months during the previous calendar year.
An invoice will be sent upon receipt of the application. No payment of assessment fee should be made in advance. Please make sure that the whole amount will be credited to our account net of any charges from the issuing or receiving bank.
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