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Assessment fees

19.09.2016
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The assessment fees of Marketing Authorisation Applications for medicines for national, mutual recognition and decentrilised procedure

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.

Type of applicationPrice (€)
Complete application, fee per one human medicinal product:
Stand alone application
Bibliographic application
Fixed dose combination  application
Informed consent application
1275
Complete application, fee per one veterinary medicinal product
Stand alone application
Bibliographic application
Fixed dose combination  application
Informed consent application
958
Abridged application, fee per product
Generic application
Hybrid application
958
Subsequent pharmaceutical form or strength containing the same active ingredient of the same future marketing authorisation holder511
Licence for parallel import, per product and exporting country639
Fee for traditional herbal medicinal product958
Fee for homeopathic preparation958
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


The assessment fees for repeat use and renewal of Marketing Authorisation Applications for national, mutual recognition and decentralised procedure

Type of applicationPrice (€)
Fee per one medicinal product639
Subsequent pharmaceutical form or strength containing the same active ingredient of the same future marketing authorisation holder383
Fee for traditional herbal medicinal product383
Fee for homeopathic preparation383
Additional fee to cover the participation of the State Agency of Medicines in the repeat use mutual recognition procedure as Reference Member State3000
Additional fee to cover the participation of the State Agency of Medicines in  the renewal of mutual recognition procedure or decentralised procedure as Reference Member State3000


The assessment fees of Variation Applications for national, mutual recognition and decentrilised procedure*

Type of applicationPrice (€)
Variation Type IB100
Variation Type II383
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 variations500
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 variations1000

* 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.


Fee for Monitoring the Safety and Quality of Medicinal Products

 Price (€)
The fee for monitoring safety and quality of a medicinal product per marketing authorization160
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 substance320

An invoice will be sent to the marketing authorisation holder by 1 February 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.