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Submission of application documentation for assessment of non-interventional clinical trials


Under Medicinal Products Act (Official Gazette, No 76/13, 90/14), Ordinance on Pharmacovigilance (Official Gazette, No 83/13) and Ordinance on Clinical Trials and Good Clinical Practice (Official Gazette, No 25/15) the Agency for Medicinal Products and Medical Devices (HALMED) is responsible for authorising non-interventional studies.

The applicant for non-interventional studies is obliged to submit to HALMED the following documents (one copy in electronic form and one in paper form):

  • Application for authorising non-interventional trials that, among others, must contain the name and signification of non-interventional study plan, name and address of the authorisation holder, name and address of the sponsor, name and address of the applicant and the list of principal investigators and institutions where the non-interventional study will be conducted. The application must be in Croatian, on an official memorandum, signed by the applicant’s responsible person and the official seal.
  • Completed application form for applying for and assessment of non-interventional studies accessible on the HALMED webpages in the Application form section, or here.
  • Investigation plan (sign, version and date)
  • Test list of subjects
  • Approved 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 investigation plan for having an insight
  • Proof of payment ( a proper offer for payment should be created by using the application Web offers)
  • Proof of paid administrative fee of 70.00 kn
  • Opinion of the Central Ethics Committee on the non-interventional study.

In order to speed up the non-interventional trial assessment procedure, the documentation without the opinion of the Central Ethics Committee, should be submitted to HALMED at the same time when submitting it to the Central Ethics Committee. The applicant is obliged to submit this opinion immediately after receiving it. When the opinion is submitted to HALMED, the clock starts for the assessment of non-interventional as set out in the Medicinal Products Act and the Ordinance on Clinical Trials and Good Clinical Trials.

Exceptionally, if it is about non-interventional trial under Article 163, Paragraph 1 of Medicinal Products Act, the applicant is obliged to act in accordance with the GVP module VIII (Guideline on good pharmacovigilance practices (GVP) Module III - Post-authorisation safety studies) and the documentation should be submitted to HALMED as set out in the addendum of the latter (Guideline on good pharmacovigilance practices: Module VIII addendum I - Member States’ requirements for transmission of information on non-interventional post-authorisation safety studies).

These instructions for submission of documentation for applying and assessment of non-interventional studies are accessible on the HALMED webpages, in the Pharmacovigilance Section, or here.