Administrative Law

National Mark of Conformity – A Certificate of Conformity with Serbian Standard

Pursuant to Article 7, paragraph 1, item 12) of the Law on Standardization (Official Gazette of RS no. 36/2009 and 46/2015) (“the Law”), the Institute for Standardization of Serbia (“the Institute”) published on April 12, 2022, the Rules for obtaining approval for the use of the National Mark of Conformity with Serbian standards (“the Rules”).

Turkish Healthcare Agency Publishes Guidelines on Homeopathic Products

The Turkish Medicines and Medical Devices Agency ("Agency") published the Guideline on License Application for Homeopathic Medicinal Products (“Guideline on Licensing”) and the Guideline on the Packaging, Homeopathic Medicinal Product Information, Legibility and Tracking of Homeopathic Medicinal Products (“Guideline on Packaging”) on March 15, 2022. Both Guidelines are based on Homeopathic Medicinal Products Licensing Regulation (“Regulation”). Within the scope of the Guidelines, the Agency has started accepting license applications for homeopathic medicinal products through the website www.ebs.titck.gov.tr, as of April 1, 2022.

The New Regulation on Health Technology Assessment in the European Union

In January 2022, the new Regulation (EU) 2021/2282 of the European Parliament and the Council of the European Union of 15 December 2021 on health technology assessment (the "HTA Regulation") entered into force on the territory of the European Union. The HTA Regulation aims to harmonize (but not to fully centralize) the currently fragmented procedure for assessing the health technologies of innovative medical therapies entering the European Union market in different European countries. The HTA Regulation shall begin to apply in stages from 12 January 2025 and the European Commission has already approved an implementation plan until that date, which includes mainly the establishment of the information resources needed for its operation, the creation of new supranational bodies to participate in the application of the Regulation and training of the competent national authorities.

DGKV Advise on Incorporation of Elina Svitolina Foundation in Bulgaria

Djingov Gouginski Kyutchukov & Velichkov has advised Ukrainian professional tennis player Elina Svitolina on the incorporation and establishment of the Elina Svitolina Foundation in Bulgaria.

Novelties in the Croatian Companies Act and Court Registry Act – Another Half-Reform Missing the Opportunity To Make Things Truly Simpler for Entrepreneurs

On the 9th of March 2022, the Croatian Parliament adopted the amendments to two crucial Croatian laws – the Companies Act (ZTD) and Court Registry Act (ZSR). Most of the amendments to the ZSR entered into force on the 24th of March; two articles will be entering into force on the 1st of August 2022, and another one on the 1st of August 2023. Amendments to the ZTD are still to come into force, some on the 1st of June 2022, and others (the most significant ones) only on the 1st of August 2023.

Cancelation of COVID-19 Restrictive Measures for Entering the Republic of Serbia

More countries, that have, until recently, been considered the pandemic’s epicenter, are easing COVID restrictions. Serbia takes the same direction and cancels majority of COVID-19 related restrictive measures.

Amendments to Certain By-Laws Passed to the Law on Electronic Invoicing

Several amendments to the by-laws passed to the Law on Electronic Invoicing (“the Law”) are published in the Official Gazette of the Republic of Serbia no. 46 dated 8 April 2022, i.e.: