According to Ministerial Decision DYG3a/G.P.171107/31.12.08 (Government Gazette B' 2689 / 31.12.2008), the fees for new applications and amendments/renewals in Greece are as follows:
When Greece is CMS
NEW REQUESTS
1. New active substance: €15.000,00
2. Known active substance: €10.000,00
3. Bibliographic application with studies of the applicant: €10.000,00
4. Well-established use: €8.000,00
5. Hybrid application: €10.000,00
6. Application for a generic where bioequivalence is required: €6.000,00
7. Application for a generic where bioequivalence is not required: €4.000,00
8. Application with consent (Informed consent): €3.000,00
9. Fixed combination of known active substance: €15.000,00
For each additional format/content the fee is: €3.000,00
In case of an application for a generic or hybrid product, the fees for each additional form/strength are: €2.000,00
MODIFICATIONS/RENEWALS
1. Type IA modification per pharmaceutical form and strength: €300,00
2. Type IB modification per pharmaceutical form and strength: €500,00
3. Type II variation – new indication per pharmaceutical form: €3.000,00
4. Type II modification – safety or quality per pharmaceutical form: €1.000,00
5. Renewal fee per trade name (trade. Mark): €1.500,00
The fees must be deposited in the
Bank of Greece
University of 21
Athens Postal Code 10250
IBAN: GR5301000240000000000263038
SWIFT CODE: BNGRGRAA
Account number: 263038
A copy of the payment should be sent to EOF.
Within the framework of the implementation of Law 5135/2024 on digital transaction fees, as of 1/12/2024, the 2,4% Stamp Duty on reservations is abolished.
