Can projects involving clinical evaluation medicines and medical devices be submitted to the competition?

The competition is open to projects that involve research into the properties or new forms of application of already registered medicinal products, so-called low-intervention and cluster studies. The sponsor of the clinical evaluation must always be the applicant or the future beneficiary (in this case, the applicant must be a healthcare facility). Failure to comply with this condition is a reason to exclude the project proposal from the tender.

It is not possible to submit project proposals for the competition that consist in clinical evaluation of medicines according to the provisions of Act No. 378/2007 Coll., on Medicinal Products and on the Amendment of Certain Related Acts, as amended, and medical devices according to Act No. 268/2014 Coll., on Medical Devices and on the Amendment of Act No. 634/2004 Coll, on administrative fees, as amended, which are not registered or which would require a change in the registration, including a change procedure (i.e. change of the medicinal substance, form of administration, strength, package size, use of an approved medical device other than as declared by the manufacturer, etc.).