Submission of the documentation for reporting and assessment of non-intervention trials
21.10.2013
According to the Medicinal Products Act (Official Gazette, No 76/13) and the Ordinance on pharmacovigilance (Official Gazette no 83/13), the Agency for Medicinal Products and Medical Devices (HALMED) is the competent authority for authorisation of non-intervention trials.
The applicant for granting the authorisation for non-intervention trial is required to submit to HALMED the following documents (in electronic and paper form) in two examples:
- The application for granting the authorisation for non-intervention trial, which, among others, must contain the name and the label of the non-intervention trial plan; name and address of the marketing authorisation holder, name and address of the trial sponsor, name and address of the applicant and the list of principal investigators and institutions in which the non-intervention trial will be carried out. The application must be in Croatian, on an official memorandum, signed by the responsible person and officially sealed.
- A completed application form for reporting and assessment of non-intervention trial which is accessible on the HALMED website, in the section Application Forms, or here.
- The investigation plan (label, version, date)
- Test list of subjects
- Authorised Summary of Product Characteristics and Package Leaflet in Croatian
- Informed consent for patients in Croatian (version and date)
- Original of the informed consent for patients in English (version and date), if applicable
- Financial plan of the investigation
- The opinion of the Central Ethics Committee about the non-intervention study
The investigation from the Art. 163 paragraph 2 of the Medicinal Products Act (OG, No 76/13) may start in the Republic of Croatia based on the written HALMED’s opinion.
By derogation, if it is about a non-intervention trial from the Art. 163 paragraph 1 of the Medicinal Products Act (OG, No 76/13), the applicant is required to provide to HALMED an insight in the following:
- Written consent of the PRAC for carrying out the non-intervention trial
- Non-intervention Trial Plan, adopted by the PRAC
- Test list of subjects
- Informed consent of patients in Croatian (version, date), if applicable
- The list of principal investigators and institutions where the non-intervention trial will be carried out
- Planned beginning and completion of the non-intervention trial
- The opinion of the Central Ethics committee about the non-intervention trial
The non-intervention trial from the Art 163, paragraph 1 of the Medicinal Products Act (OG, No 76/13) may start in the Republic of Croatia based on the PRAC’s written consent, after the marketing authorisation holder has submitted to HALMED the adopted plan. According to the Art. 20 of the Ordinance on pharmacovigilance (OG, No 83/13) the local person responsible for pharmacovigilance must have an overview on the safety profile and all safety issues on medicines for which the marketing authorisation holder has marketing authorisations. On the basis of the aforementioned, the local responsible person for pharmacovigilance must have an overview over safety issues of medicines that are in non-intervention trials in the Republic of Croatia.
