Medicines

Draft Order of the Ministry of Health of Ukraine "Certain Issues Related to the Importation into the Customs Territory of Ukraine, Accounting, Storage, Use, Destruction, Disposal or Exportation from the Customs Territory of Ukraine of Investigational Medicines"; (9 page(s), in Ukrainian)

The draft Order has been developed in accordance with the requirements of Paragraph 20 of Article 10 of the Law of Ukraine "On Medicines" No. 2469-IX of 28 July 2022, taking into account relevant European Union legislation.

The draft Order:

1) approves the Requirements for the importation into the customs territory of Ukraine, accounting, storage, use, destruction, disposal or exportation from the customs territory of Ukraine of investigational medicines and auxiliary medicines, which shall apply to the importation in Ukraine, accounting, storage, use, destruction, disposal or exportation from Ukraine of both unregistered and registered investigational medicinal products and auxiliary medicinal products used in the course and within the framework of clinical studies (trials);

2) establishes that:

the requirement that investigational medicines (excluding active pharmaceutical ingredients (APIs)), manufactured and released by the manufacturer's qualified person for use in clinical trials in Ukraine and imported from countries that are not Member States of the European Union or members of the European Free Trade Association that are parties to the Agreement on the European Economic Area, may be imported into the customs territory of Ukraine exclusively by business entities engaged in the importation of investigational medicines, shall apply from 1 January 2028; from the date of entry into force of this Order until 1 January 2028, investigational medicinal products imported into the customs territory of Ukraine from countries that are not Member States of the European Union or members of the European Free Trade Association that are parties to the Agreement on the European Economic Area may be imported by the sponsor or by a person authorized by the sponsor on the basis of a power of attorney and/or a contract for the importation of investigational medicinal products into the customs territory of Ukraine.