On 13 October 2023 a new regulation governing solar and wind power plants’ connection to Serbia’s transmission and distribution system came into effect. This update brings significant changes to the process of connecting new power generation facilities.

For initial connections, in addition to the construction permit, a connection feasibility study and agreement must now be drawn up. Submission deadlines for connection studies have also been defined, with the Serbian Transmission System Operator (EMS) conducting studies biannually. It is important to highlight that the first connection study period begins on 20 December 2023, with a submission deadline of 1 December 2023. In addition, connection studies can become invalid if certain conditions have not been met, including a failure to provide an investor bank guarantee within 60 days in order to ensure the timely conclusion of contracts, approvals and construction.

On another note, deposit requirements based on capacity have also been introduced, with varying set fees for different capacity levels.

Once approval for connection to the transmission system is granted, this can now be issued for a three-year period and can also be extended once for up to two additional years if requested by the investor.

In summary, these regulatory changes are expected to streamline the process of connecting power generation facilities to the grid and are designed to bolster the security and reliability of Serbia’s electrical energy supply.

Recent amendments to the Regulation on Clinical Trials of Medicinal Products in Human Medicine have recently been adopted and take effect from 11 October 2023. These mainly involve changes to the provisions that regulate the requirements governing the status of Principal Researcher, as well as introducing new obligations for clinical trial sponsors.

Sponsors must now – in addition to other essential documentation – submit a document to the Agency for Medicines and Medical Devices of Serbia (ALIMS) entitled “Institutional Consent in accordance with the statute to conduct research in the healthcare institution” in order to gain approval for clinical trials. This must include a statement that the proposed Principal Researcher meets the requirements set out in these latest amendments.