From February 9, 2019, Directive on the prevention of the admission of counterfeit drugs into legal trading networks, which provides for special coding of medicines, has come into force in the EU. This means that Ukrainian manufacturers who export medicines must adhere to this coding.
The verification system (serialization, or 2D coding) was adopted as a means to prevent adulteration and control of drug circulation. Such code is a unique identifier containing the name, pharmaceutical form, concentration, size, type of packaging, national number information, serial number, expiration date and manufacturer information. The introduction of such a coding system would allow the state to track the entire “path” of medicines (from production or import to sale at a pharmacy).
In Ukraine, a pilot project on 2D control marking and monitoring of drug circulation was to start on September 1, 2019, but this did not happen.
Having examined the conditions and possibilities of implementation of the pilot project, it was decided to refine its requirements for harmonization with the requirements of European legislation, and the discussion of the pilot project with the manufacturers showed that the companies could not fulfill the conditions of the pilot project on time, because to start serialization it is necessary to make changes in registration materials, to adapt production, re-register batches of medicines already issued, etc. And now the pilot project should start from November 1, 2020, allowing more time for manufacturers to modify the conditions.
The Ministry of Health and other initiators of the pilot project appealed to the new Cabinet of Ministers requesting to review and accept as soon as possible the amendments to the Resolution on the introduction of the pilot project, which will allow to postpone its launch from September 2019 to autumn 2020. From November 1, 2021, the drug verification system should become mandatory for the entire business.
