Supporting documents and forms
Select the available forms from the list below, which is constantly updated:
Pharmaceutical Pricing Department – Procedures and supporting documents
Core Products and Requirements at National Level
Applications
Application for renewal of marketing authorization for proprietary medicinal products for human use
Application for amendment of marketing authorization for proprietary medicinal products for human use
Application for the transfer of a marketing authorization for a pharmaceutical product
'Drug approval
Human drug approval form based on the Clinical Trial Development (CTD)
Checklist of supporting documents for requests for approval of marketing authorisation for medicinal products for human use
Proprietary preparation/preparation for human use
General information
Administrative information
Scientific information
Parallel exports
1.Submission Table Template – ISO 3166 Country Codes
2. Instructions for the correct completion of the Tables
Compassionate use
Procedure and forms for granting early access to a medicinal product for human use:
- Application to the EOF
- Documents
- Update 06.07.2010
- Ministerial Decision
- Patient information form
- Patient consent form
Authenticity films
Unsuitable film pasting notice
Conference funding
Application form
Procedures and instructions
Get informed and receive instructions for various procedures from the list below:
Proprietary products not available in Greece
Regarding their distribution and availability through private pharmacies, for individual use
Good manufacturing rules
Good manufacturing practices for cytotoxic pharmaceutical products
Measures for the issuance of “non-compliance” certificates with the Good Friday Rules
Destruction of semi-finished and finished products under the jurisdiction of EOF
Regulation of bioequivalence issues (Circular 56054/3-9-08)
Co-promotion
of a pharmaceutical product from two pharmaceutical companies
Submitting files
Instructions for submitting files in electronic format
Fees
Fees for human medicines
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 €20.000,00
2. Known active substance €20.000,00
3. Bibliographic application €20.000,00, with studies by the applicant
4. Well-established use: €18.000,00
5. Hybrid application €20.000,00
6. Application for a generic of €14.000,00, where bioequivalence is required.
7. Application for a generic €9.000,00, where bioequivalence is not required
8. Application with consent €5.000,00
9. Fixed combination €20.000,00
10. License extension €10.000,00
For each additional format/content the fee is €5.000,00.
In the case of an application for a generic or hybrid product, the fees for each additional form/strength are €3.000,00
MODIFICATIONS/RENEWALS
1. Type IA modification: €500,00
2. Type IB modification: €1.000,00
3. Type II variation – new indication: €5.000,00 per pharmaceutical form
4. Type II modification – safety or quality: €2.000,00 per pharmaceutical form
5. Modifications for products under approval: €300,00
6. Amendment to the name or address of the MAH of already approved medicinal products: €100,00
7. Change of MAH: €1.000,00
8. Renewal fee: €5.000,00
Fees must be deposited at:
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.
