Medicines

Draft Resolution of the Cabinet of Ministers of Ukraine "On Amendments to Clause 6 of the Procedure for State Quality Control of Medicines Imported into Ukraine"; (2 page(s), in Ukrainian), (2 page(s), in English)

The draft Resolution of the Cabinet of Ministers of Ukraine "On Amendments to Clause 6 of the Procedure for State Quality Control of Medicines Imported into Ukraine" has been developed to deregulate the process of state control of radioactive and radiopharmaceutical medicines imported into Ukraine, as well as and to facilitate open electronic interaction between executive authorities and business entities.

Radioactive and radiopharmaceutical medicines are specific sources of ionizing radiation, the active ingredient of which is a radioactive isotope (radionuclide). They are widely used worldwide and in Ukraine for the diagnosis and treatment of oncological diseases. Manufacturers of radioactive and radiopharmaceutical medicines release new batches on a weekly basis, which is related to the unique physical characteristic of these drugs - the half-life of the radionuclide (the time it takes for half of the atoms of a given radionuclide to decay). For example, the half-life of Iodine-131 (I-131) is 8 days. Additionally, radioactive and radiopharmaceutical medicines have a short shelf life, ranging from 21 to 28 days from the date of production.

The draft Resolution aims to resolve discrepancies between the requirements of the Procedure for State Quality Control of Medicines Imported into Ukraine, approved by the Resolution of the Cabinet of Ministers of Ukraine on 14 September 2005 No. 902, and the physical properties of radioactive and radiopharmaceuticals in order to prevent delays or rescheduling of diagnostics and treatment for cancer patients, thereby reducing significant risks to their health and life.

The proposed amendments comply with the requirements of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use in terms of the wholesale trade in medicines (distribution) and imports, including radiopharmaceuticals. In addition, to ensure efficient, transparent and open electronic interaction between executive authorities and business entities in accordance with the Law of Ukraine "On Electronic Documents and Electronic Document Management", it is proposed to add Clause 6 with a new rule regarding the submission of information on imports and accompanying documents through the e-government web portal for quality control of medicines of the State Service of Ukraine on Medicines and Drugs Control.