General eligibility criteria for Greece
Pharmaceutical products evaluated by the Prix Galien Greece Awards must be based on innovation and developed using chemical, biological, or biotechnological processes. Applicants must provide detailed and accurate specifications regarding the products’ manufacturing processes, as well as the results of their clinical trials.
Products submitted for consideration must have received marketing authorization in Greece, including approval of the relevant indication but not necessarily pricing approval, through a centralised, national, or mutual recognition procedure, between January 1st 2022 and April 30th 2026, inclusive.
The above criteria also apply to previously approved products that have subsequently received approval for a new, innovative indication or a new therapeutic benefit (NTE, New Therapeutic Entity), provided that such approval has been granted within the preceding four (4) years.
Qualitative criteria
Candidate products may belong to any therapeutic category. However, the Awards will be conferred to those products that contribute to improving patients’ quality of life or saving lives, based on the following two criteria:
- What was the degree of innovation demonstrated throughout the scientific development of the product, including its mechanism of action and clinical utility?
- What is the potential contribution of the product to the future advancement of medical science through its introduction into clinical practice?
Only one winner shall be selected in each Award category. However, in the event of a tie between two or more candidates, the Jury reserves the right to designate a second winner under the Hors Prix distinction.
The following factors shall not be taken into consideration in the evaluation process: market size (including the number of cases or product sales), company size, development costs, or any other factors related to product distribution that are beyond the applicant’s control.
Specific eligibility and submission criteria for Greece
Products eligible for consideration in this category must be approved in the European Union and commercially available in Greece.
Proposal summary (up to 1 page)
The proposal should begin with a concise summary outlining the product’s principal indications and highlighting the key elements of the nomination.
Rationale and innovation (up to 3 pages)
This section should address the following:
- The background and rationale behind the development of the product, including how and why it was developed.
- Whether the product addresses a unique and clearly defined therapeutic target.
- The use of innovative technologies or approaches in the development of the product.
- The originality and innovative aspects of its chemical or biotechnological development.
Clinical evaluation (up to 2 pages)
This section should provide a summary of the clinical development programme, including the key elements relating to:
- The product’s mechanism of action.
- The dosing regimen.
- The design and methodology of the clinical trials.
The submission may include information from up to 10 peer-reviewed publications.
Conclusions (up to 1 page)
This section is optional. Applicants may, however, wish to provide a concise summary of the product’s key strengths, advantages and added value.
Submission and formatting requirements
The total length of the nomination dossier for each award category must not exceed 12 A4 pages.
The document should be prepared using:
- 12-point Arial font
- 1.5 line spacing
- 2 cm margins
All supporting documentation and relevant certificates must be submitted electronically together with the awards application online form.
Application fees
For further information regarding the application fee and the benefits associated with your nomination for the “Best Pharmaceutical Product”, please contact us at info@jpcom.gr or by phone at +30 210 813 2828 or +30 210 813 2366.