Notification/approval of clinical trials
Notification/approval of clinical trials
Decisions on applications for approval/notification of clinical trials are made by JAZMP Clinical trials may begin when the conditions from Article 59 of the Medicinal Products Act (ZZdr-1) are met and a favourable opinion of the National Medical Ethics Committee of the Republic of Slovenia (http://www.kme-nmec.si) is obtained.
Application for notification/approval of clinical trials
Either a sponsor or sponsor's representative (written authorisation by sponsor) may apply for a clinical trial. The sponsor or sponsor's representative must be established in the EU.
The application must be submitted to the address of JAZMP, Einspielerjeva 6, 1000 Ljubljana. At the same time, the application should also be submitted to the National Medical Ethics Committee. In the case of clinical trials with genetically modified organisms (GMO) it is necessary to obtain a special permit from the Ministry of Environment and Spatial Planning.
E-mail address for issues relating to the area of clinical trials: CT@jazmp.si.
The application should be prepared in accordance with Article 20 of the Rules on clinical trials of medicinal products (Uradni list RS, No. 54/06):
- the relevant forms are: KLPR-A , KLPR-B, KLPR-C,
- The covering letter must be in Slovenian and must have the EudraCT* number of clinical trial stated as reference.
*EudraCT number: International identification number of clinical trial. The applicant obtains a EudraCT number for each new clinical train on the EudraCT website: https://eudract.ema.europa.eu/.
Non-commercial clinical trials
The application for notification/approval of a non-commercial clinical trial should be prepared in accordance with Article 20 of the Rules on clinical trials of medicinal products ( Uradni list RS, No. 54/06). Relief is provided in payment of the fee.
Non-interventional clinical trials
Prior to the beginning of a non-interventional clinical trial, the applicant must notify JAZMP of this in accordance with Article 29 of the Rules on clinical trials of medicinal products (Uradni list RS, No. 54/06).
Substantial amendmentsThe duty of the sponsor is to notify JAZMP of any substantial amendments in accordance with Article 23 of the Rules on clinical trials of medicinal products (Uradni list RS, No. 54/06).
End of clinical trial
After end of a clinical trial, the applicant must notify JAZMP of this in accordance with Article 27 of the Rules on clinical trials of medicinal products (Uradni list RS, No. 54/06).
Suspected unexpected serious adverse reactions (SUSARs)
In accordance with Article 31 of the Rules on clinical trials of medicinal products (Uradni list RS, No. 54/06), the sponsor is obliged to regularly and promptly notify any serious unexpected adverse reactions or suspicion thereof in electronic form, by sending the data directly to the European database EudraVigilance-CT module.
Annual/periodic safety update reports
Sponsors must submit their regular periodic and annual safety update reports in accordance with Articles 32 and 33 of the Rules on clinical trials of medicinal products (Uradni list RS, No. 54/06):
Approved/notified clinical trials
List 1 Jan 2011 – 31 Dec 2011
Resni nepričakovani neželeni učinki zdravil (SUSARs)
Sponzor je v skladu z 31. členom Pravilnika o kliničnih preskušanjih zdravil (Uradni list RS, št. 54/06), dolžan redno in pravočasno obveščati o vseh resnih nepričakovanih neželenih učinkih ali sumu nanje v elektronski obliki, s pošiljanjem podatkov direktno v evropsko bazo podatkov EudraVigilance-CT modul.
Letna /periodična poročila
Sponzor mora pošiljati redna periodična in letna varnostna poročila v skladu z 32. in 33. členom Pravilnika o kliničnih preskušanjih zdravil (Uradni list RS, št. 54/06).
Odobrena/priglašena klinična preskušanja
