The draft order was developed by the Ministry of Health of Ukraine in order to implement the Procedure for the manufacture, quality control and circulation of bioimplants, approved by the resolution of the Cabinet of Ministers of Ukraine of February 24, 2021 № 158.
The draft act and accompanying documents are posted at https://moz.gov.ua/article/public-discussions/proekt-nakazu-moz-ukraini-dejaki-pitannja-vigotovlennja-kontrolju-jakosti-ta-obigu-bioimplantativ from July 21, 2021.
The draft order proposes to approve:
– the procedure will determine the mechanism of keeping records of manufacturers and authorized representatives responsible for the introduction of bioimplants, the form of notification, the list of information stored during this accounting, and the mode of access to them.
Registration of manufacturers and authorized representatives will be kept in electronic form by the State Medical Service.
– the procedure for conducting inspection and control measures for compliance with the requirements of the organization of the quality system in the institution that provides anatomical materials;
– the form of the Notice of the beginning of activity on extraction of anatomic materials from the donor-corpse for production of bioimplants, storage and transportation;
– the form of the Report on a serious adverse reaction;
– the form of the Notice of recall of anatomical materials from the manufacturer of bioimplants;
– the form Information on confirmation of a serious adverse reaction;
– the form of the annual report on the activities of the institution that provides anatomical materials.
The analysis of the regulatory impact on the draft act states:
– The amount of funds that will be spent by the business entity in connection with the requirements of the act – 254 794, 86 UAH.
– Costs for business entities that are producers of bioimplants are related to the implementation of a quality management system, which must be certified in accordance with the relevant DSTU EN ISO by a conformity assessment body accredited in this field and amount to UAH 254,794.86 for 5 years for all business entities
– The number of business entities to which the act will apply is projected at 55 agricultural years.
– The amount of time that will be spent by the business entity in connection with the requirements of the act – 335.5 hours.
– The amount of money and time spent by businesses in connection with the requirements of the act – is high.
The draft order needs to be approved by the Ministry of Digital Transformation of Ukraine, the State Service of Ukraine for Medicines and Drug Control, and the State Regulatory Service of Ukraine.
The draft order requires state registration with the Ministry of Justice of Ukraine.
The explanatory note to the draft order states that bioimplant manufacturers will benefit from the implementation of this draft order, as it will allow bioimplant manufacturers to operate in accordance with clearly defined rules. At the same time, importers of bioimplants, according to the Ministry of Health of Ukraine, will have a negative impact from the adoption of this draft act, as the development of bioimplants in Ukraine will reduce the price of such products and reduce profits of importers.
If adopted, this order shall enter into force on the day of its official publication.