CLINICAL TRIAL APPLICATION SUBMISSION UNDER THE CLINICAL TRIALS DIRECTIVE (EC) NO. 2001/20/EC AND ZZDR- 2 THROUGH NATIONAL SUBMISSION PROCESS
During transition period from 31 January 2022 until 31 January 2023, the sponsors may submit applications for clinical trials in accordance with the Clinical Trials Directive No. 2001/20 / EC and national law.
Legislation of Republic of Slovenia related to clinical trials:
- Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14 and 66/19)
- Rules on clinical trials of medicinal products (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 54/06)
EU Legislation related to clinical trials:
Directives and recommendations of the European Committee: EudraLex – Volume 10 Clinical trials guidelines: http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/vol-10/index_en.htm
NOTIFICATION/AUTHORISATION OF CLINICAL TRIALS
Clinical trials of medicinal products may start when conditions from Article 35 and 37 of the Medicinal Products Act (ZZdr-2) are met, and when a favourable opinion of the Republic of Slovenia National Medical Ethics Committee (NMEC) (Slovenian language only) (https://www.gov.si/zbirke/delovna-telesa/komisija-rs-za-medicinsko-etiko) is obtained.
- Preparation of application for notification/authorisation of clinical trials:
Either a sponsor or sponsor’s representative (written authorisation by sponsor required) may apply for a clinical trial. Sponsor or sponsor’s representative must be located in the EU.
The application must be submitted to the following address: JAZMP, Slovenčeva ulica 22, 1000 Ljubljana, Slovenia. At the same time, the application should also be submitted to the NMEC.. In case of clinical trials with genetically modified organisms (GMO), a special licence from the Ministry of the Environment and Spatial Planning must first be obtained.
Electronic address for questions regarding clinical trials:
The application must be prepared in accordance with Article 20 of the Rules on clinical trials of medicinal products (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 54/06).
Corresponding forms (Slovenian language only):
The cover note must be written in the Slovene language and must also contain the EudraCT number of the clinical trials as reference.
(EudraCT number: international identification number for clinical trials. The proposer obtains the EudraCT number for each new clinical trials at the EudraCT website (https://eudract.ema.europa.eu))
- Non-commercial clinical trials
The application for notification/authorisation of non-commercial clinical trials must be prepared in accordance with Article 20 of the Rules on clinical trials of medicinal products (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 54/06). Reduced fees are applicable.
- Non-interventional clinical studies
The sponsor notifies JAZMP about non-interventional clinical studies in accordance with Article 40 of ZZdr-2.
PROCEDURE FOR NOTIFICATION OF SUBSTANTIAL AMENDMENTS
The duty of the sponsor is to notify JAZMP regarding all substantial amendments in accordance with Article 23 of the Rules on clinical trials of medicinal products.
END OF CLINICAL TRIALS
After completed clinical trials of the medicinal product, the applicant must submit a notification regarding the end of clinical trial to JAZMP in accordance with Article 27 of the Rules on clinical trials of medicinal products.
One year after the end of a clinical trial, the applicant must submit a summary report of clinical trial to JAZMP.
REPORTING OF SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS (SUSARS)
In accordance with Article 31 of the Rules on clinical trials of medicinal products, the sponsor must regularly and in due time make known all suspected unexpected serious adverse reactions by sending the relevant data in electronic form directly to the European database »EudraVigilance-CT module«.
- Annual/periodic reports
The sponsor sends regular periodic and annual safety reports (DSURs) in accordance with Articles 32 and 33 of the Rules on clinical trials of medical products.