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According to the Ministerial Degree ΔΥΓ3α/Γ.Π.171107/31.12.08 issued in the Official Journal of the Government No 2689 on 31th of December 2008, with effect from 31-12-2008, the fees for new applications and variations/ renewals/ concerning veterinary medicinal products in Greece, are set as follows:
When Greece is CMS and for National Applications
NEW APPLICATIONS
1. New active substance:15.000,00 €
2. Known active substance (full dossier):10.000,00 €
3. New application based on bibliographic application 10.000,00 € , with studies conducted by the applicant
4. New application based on well established use: 8.000,00 €
5. Fixed combination of known substances: 15.000,00 €
6. New hybrid application :10.000,00 €
7. New generic application :6.000,00 € , when bioequivalence is submitted.
8. New generic application :4.000,00 € without bioequivalence
9. Informed consent application: 3.000,00 €
For each additional form/strength for 1,2,3, 4 and 5 the fees are 3.000,00 €.
For each additional form/strength for 6,7,8 and 9 the fees are 2.000,00 € .
VARIATIONS/RENEWALS
1. Variation type IA: 300,00 € per pharmaceutical form and per strength
2. Variation type IB: 500,00 € per pharmaceutical form and per strength
3. Variation type II – new indication: 3.000,00 € per pharmaceutical form
4. Variation type II – safety or quality: 1.000,00 € per pharmaceutical form and per strength
5.Fees for renewal: 1.500,00 € per trade mark
The fees should be payable to
Bank of Greece
Panepistimiou 21
Athens 10250
Greece
IBAN: GR5301000240000000000263038
SWIFT CODE: BNGRGRAA
Account number: 263038
A copy of payment must be submitted to:
NATIONAL ORGANIZATION FOR MEDICINES
284 Messogion Av.
Holargos GR 15562 ATHENS GREECE
Within the framework of the implementation of Law 5135/2024 on digital transaction fees, as of 1/12/2024 the Stamp Duty of 2,4% on reservations is abolished.
