Non-commercial clinical trials
Clinical trials which are carried out without the pharmaceutical industry taking part, by independent investigators from the pharmaceutical industry are not considered to be commercial investigations.
. The following criteria have to be fulfilled:
• concerning the sponsor:
- university, hospital, scientific organization, non-profit institution or a research worker may act as a sponsor
- owner of the data has to be one of the above mentioned entities
- there cannot be any contract between the sponsor and a third person with regards to application of the data for a marketing authorisation or marketing of the product
- sponsor is responsible for planning, coordinating, recording data and reporting
• concerning the clinical trial:
- the investigation cannot be a part of a development programme
- the investigation cannot be applied for a marketing authorisation
In case of non-commercial clinical trials please refer to the §13 and §14 of Decree No. 35 of 26 August, 2005 of the Minister of Health with the difference that the following information has to be submitted to the National Institute of Pharmacy as a simplified investigation plan: reason for the investigation, number of participants, planned time and method of recruitment.