Notification of clinical trials on medicinal products

The approval for clinical trials of a medicinal product must be acquired when testing will be implemented with:

•  medicinal products for genetic treatment;
• with medicinal products for treatment with somatic and xenogeneic cells;
• with medicinal products that contain genetically modified organisms.

The notification of clinical trials of a medicinal product is required in all other cases that are not indicated in the previous paragraph.

The notification of the clinical trial of a medicinal product is not necessary for non-intervention clinical trials.

The applicant sends the application for the approval of a clinical trial to the competent authority.

The application is prepared based on the recommendations of the European Commission; EudraLex - Volume 10 Clinical trials guidelines.

The application for approval or notification must contain:

•  an accompanying letter - when the application is lodged in the name of the sponsor by a proxy, they have to submit the authorisation letter of the sponsor;
• complete and signed uniform European form for the approval or notification of a clinical trial for a medicinal product;
• the trial protocol signed by the sponsor and main researcher or researcher coordinator in the case of multi centric clinical trials;
• brochure for the researcher;
• investigational medical product dossier (IMPD):

 - the entire investigational medical product dossier is submitted by the applicant when the data on the medicinal product in clinical trial is sent to the authority responsible for medicinal products for the first time;

- short version of the dossier is submitted by the applicant when the medicinal product in clinical trial has obtained the authorisation for trading in any EU Member State or the authority competent for medicinal products acquired data on the medicinal product from another clinical trial;

- summary of main features of the medicinal product, when the clinical trial does not exceed the frames of the summary;

- the summary of the clinical trial protocol in five copies in Slovenian;

- the list of countries where the sponsor has provided an application for the same clinical trial;

- the opinion of the National Medical Ethics Committee; when the approval or notification procedure for the clinical trial is conducted simultaneously, the applicant must immediately submit the opinion of the National Medical Ethics Committee when it is available;

- the authorisation for manufacturing the medicinal product when the medicinal product in clinical trial has been manufactured in the European Union; the authorisation for import in the European Union and the statement of the responsible person that the manufacture runs in accordance with good manufacturing practice when the medicinal product in clinical trial was manufactured in third world countries;

- a short CV of the main researcher responsible for the clinical trial at an individual trial location;

- evidence on the damage liability insurance of the sponsor in case of potential damage to the tested person which emerges as the consequence of a clinical trial of a medicinal product;

- the form with written approval of the tested person and the text informing the tested person preliminarily on the purpose of the clinical trial and potential health risks (in Slovenian and English);

- completed KLPR-A form with data on the clinical trial which the applicant must submit in electronic form, i.e. Word file;

- the statement of the main researcher on the KLPR-B form that is available on the website of the authority responsible for medicinal products;

- the consent of the responsible person of the examiner (director, chief) to the appointment of the main researcher and the use of premises, staff and equipment at the implementation of the clinical trial on the KLPR-C form which is available on the website of the authority responsible for medicinal products;

- draft of the label of the medicinal product in clinical trial in Slovenian language;

- other documents in accordance with the recommendations of the European Union;

- evidence on the payment of procedure costs;

- prescribed administrative fee.

Fees in connection with the notification and clinical trial approval procedures for children and orphan designation amount to half of the value of an individual fee.

There are no fees in connection to the notification or clinical trial of a medicinal product approval within the compassionate use programme.