Ukraine changes quality control rules for imported medicines

On 21 July 2021 the Cabinet of Ministers of Ukraine amended its Resolution No. 902 On State Quality Control of Imported Medicines. The amendments took effect on 27 July 2021.

The key points contained in this Procedure include the following:

Cutting the list of countries of origin exempted from compulsory public lab testing

Previously, exemptions existed for imported medicines manufactured at facilities located in any of 54 the PIC/S countries from mandatory public lab testing. According to the Procedure, only medicines manufactured in the EU member states, UK, USA, Canada, Switzerland, New Zeeland, Australia, Japan and Israel are exempted and remain subject to visual control by public inspectors (which may still be followed with lab testing, but only when defined by the Procedure). Some international pharma companies with manufacturing facilities outside of the revised list of countries may view this development as a toughening of the rules.

Substitution of lab testing with special materials from manufacturers

The Procedure provides for two situations when lab testing must be substituted with batch release documentation issued by the manufacturer’s qualified person, namely:

• when public labs lack materials or equipment required for the testing of a particular medicine; and
• for orphan medicines.

Previously, the lack of control materials or equipment often significantly and seriously extended the timeframe for public quality control procedures.

Simplified quality control for medicine procurement by the Centralised Procurement Agency

For imported medicines procured by the Centralised Procurement Agency, local GMP certificates may now be substituted with letters of guarantee declaring GMP compliance. Moreover, for these medicines, basic quality control procedures have been shortened from eight to five days (exclusive of time for the lab testing, where required).

Cutting the list of materials required for state quality control

While applying for the quality control, it is no longer required to submit to the quality inspectorate a local marketing authorisation (i.e. registration) certificate, and a local GMP certificate (or a local recognition GMP certificate issued by an overseas inspectorate). This development that the international pharma industry has been advocating for years in Ukraine eliminates rudimentary paperwork.

Despite the positive changes contained in the Procedure, public quality control remains an outdated procedure, which is not aligned with the EU approach to quality assurance since this procedure duplicates the private quality control systems of licensed pharmaceutical importers.

For more information on this amended procedure and how it affects your Ukraine-based business, contact your CMS client partner or local CMS expert: Borys Danevych.