MOH Issues Further Guidance on Import of Unregistered Medicines

Further to its earlier letters regarding no objection to the import of unregistered medicines under martial law, from 17 March 2022 the Ministry of Health of Ukraine ("MOH") formally suspended its regulation establishing the approval procedures applicable to such import[1].

In April 2022, the MOH further clarified that while the martial law is in effect, unregistered medicinal products may be brought to Ukraine and go through customs without relevant approvals.

The Law of Ukraine "On Medicinal Products" remains in force and still sets out an exhaustive list of cases when unregistered medicines may be imported to Ukraine without the option of their further sale (e.g., to satisfy the needs of individual patients or armed forces of Ukraine).

The MOH emphasized that the responsibility for import of unregistered medicines and their further use as permitted by law lies with the importer. At the same time, given the suspension of related government approval process, it is not clear to what extent controls may and will be exercised over relevant supplies. We note that the internal sales of medicinal products in Ukraine are still only permitted to the extent such products have valid marketing authorizations.

The suspension will remain in force until the expiry or termination of martial law. The state of martial law has been declared in Ukraine through 25 April 2022 but could be further extended if required.

[1] Order of the Ministry of Health of Ukraine "On Approval of the Procedure for Import to the Territory of Ukraine of Unregistered Medicinal Products, Standard Samples and Reagents" No. 237 dated 26 April 2011 (as amended).