JAZMP decides about applications for authorisation/notification of clinical trials on the basis of the opinion of the Clinical trials Committee. The Clinical trials Committee is an expert authority at JAZMP and has a consultant role in the field of clinical trials of medicinal products for use in human medicine. Committee members are appointed from acclaimed experts in the fields of medicine, pharmacology, pharmacy, and other fields by the Minister of Health.
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) (http://www.kme-nmec.si) 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.
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.