The register of persons, responsible for placing medical products on the market, became operational in Ukraine

The Order of the Ministry of Healthcare of Ukraine of 21 December 2022 №2311 (“the Order”) approved a new version of the Procedure of maintaining the Register of persons, responsible for placing medical products, active medical products that are implanted, and medical products for in vitro diagnostics on the market (“the Procedure”). Such a decision, first of all, is aimed at the digitalisation of the healthcare sector, in particular, at the promotion of quality and convenience of placing medical products on the market and their further turnover.

The Procedure provides for the functioning of an electronic register, where the data on persons, responsible for placing medical products on the market (including active medical products that are implanted, and medical products for in vitro diagnostics), as well as the information on such medical products, are collected. In particular, the Register will include such information:

  • data on the person, responsible for placing medical products on the market (identifier);
  • products and their names, information about the type, label, model, and catalogue code; description of the product (characteristics and use);
  • declaration of conformity and, if any, certificate of conformity;
  • code and name of the product according to the National classifier.

The given data is entered based on the manufacturer’s notification about entering the information into the Register.

Access to the Register is granted only via the official website of the State Service of Ukraine on Medicines and Drugs Control: dls.gov.ua, in the section “Market surveillance”, subsection “the Register of persons, responsible for placing medical products, active medical products that are implanted, and medical products for in vitro diagnostics on the market”.

It is important that until 10 April 2023, the Order provides for a transition period, during which the manufacturers can submit notifications about entering the information into the Register both in paper form as well as on electronic carriers (.xls file extension) to the State Service of Ukraine on Medicines and Drugs Control.

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