New Procedure for Utilization and Disposal of Medicinal Products in Ukraine

Order of the MOH No 242 of 24.04.2015 approving new Regulations on utilization and disposal of medicinal products was published on the web-page of Verkhovna Rada of Ukraine.

New Regulations amend the procedure of conveyance and reporting concerning utilization and disposal of the medicinal products that are not subject for the further use.

It should be noted that Regulations on utilization and disposal, which are currently in force, operate with the definition of “waste disposal of medicinal products” and contain the specific list of categories of the medicinal products that it covers. New Regulations, despite using aforementioned definition, do not contain any specification of its content. However, applying comprehensive approach to the whole document it may be concluded that both statutory instruments regulate precisely the waste disposal of medicinal products and construe “waste” identically.

According to the new Regulations in case the aforementioned products are found, business entity shall take formal note of it in a form, approved by Regulations. Thereafter such products shall be conveyed to the special business entities, which obtained a license for hazardous waste management. Therewith business entity shall fill out the standard form of supplying information provided for in Regulations about the fact of conveyance and volume of conveyed waste.

It is to be recalled that currently a supplier or a manufacturer shall utilize and dispose waste at its own expenses. In this regard such waste may be disposed by them directly or delegated for utilization to the specialized entities. Further currently supplier and manufacturer are obliged to draw up the single document: act of disposal of waste of medicinal products. Such act shall be submitted within two weeks to controlling authority, upon decision of which the corresponding medicinal product was withdrawn from circulation.

At the same time, according to the new Regulations report on the volume and methods of disposal shall be submitted by business entity, which conveyed waste for disposal, to the authority that issued license for hazardous waste management. Such report shall be submitted on a quarterly basis.

It should be noted that the new Regulations will be in force following their official publication.


Categories: Commercial Law, Pharmaceuticals and Biotech

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