Amendment of Documentation Requirements for PART II – Clinical Trials with Radiopharmaceuticals and Clinical Trials with Medicinal Products Containing GMOs

We would like to inform sponsors, monitors, investigators, and contact persons about an amendment to the documentation requirements for Part II of the clinical trial authorisation application.

Radiopharmaceuticals:

In connection with the amendment to the Atomic Act, sponsors are no longer required to submit, together with the clinical trial authorisation application for a trial involving a radiopharmaceutical, the approval issued by the State Office for Nuclear Safety (SÚJB). Instead, sponsors are now obliged to notify SÚJB of the submission of the clinical trial application.

Legal reference:

• Act No. 83/2025 Coll. – an Act amending Act No. 263/2016 Coll., the Atomic Act, as amended
• Section 85, new paragraph 4, which reads as follows:
  “(4) The sponsor of a clinical trial involving radiopharmaceuticals shall, without undue delay, notify the Office of the submission of a clinical trial authorisation application for radiopharmaceuticals pursuant to the Medicinal Products Act.”

Medicinal Products Containing GMOs:

For medicinal products containing GMOs, the documentation requirement for Part II has been amended as follows:

Sponsors are no longer required to submit, together with the clinical trial authorisation application, the Ministry of the Environment (MoE) approval for the planned clinical trial sites. However, the obligation to obtain such approval prior to the initiation of the clinical trial remains. Once approval has been obtained, the sponsor shall upload the permit to CTIS as a Non Substantial Modification for Part II (NSM PART II).

If a clinical trial site is not approved by the MoE, the sponsor must update the information on the clinical trial sites in CTIS (to ensure correct display in the EU clinical trials database). This update must be submitted as a Substantial Modification to Part II. Following this submission, the sponsor will receive a decision from SÚKL with an updated list of sites for which the clinical trial authorisation remains valid.