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According to the Ministerial Degree DYG3a/G.P.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 paid 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.
