Import and Supply Procedures for VAT Exempt Medicines

Cabinet of Ministers of Ukraine approved the Resolution № 1153 as of December 2, 2015, which designated the import, delivery and intended use procedures for VAT exempt medicinal products and medical devices.

Enterprises, establishments, organizations (hereinafter - Importers) planning the import of medicinal products and medical devices to the customs territory of Ukraine should submit to the Ministry of Health of Ukraine within 10 days prior to such import the hard and electronic copies of the following documents:

• Application for the certificate confirming the medicinal products and medical devices import to the customs territory of Ukraine under the agreements (contracts) concluded between the Ministry of Health and specialized organizations (hereinafter – Agreements);
• Appropriately certified copy of international business agreement (contract) under which the import is planned;
• Letter of commitment to import the medicinal products and medical devices solely for the supply to the customs territory of Ukraine under the agreement;
• Certified copies of quality certificates (certificates of analysis, test reports, etc.) issued by the manufacturer for the series of medicinal products to be imported.

The Ministry of Health shall within five working days from documents delivery shall issue for the importer a certificate of import confirmation or send a written refusal notice indicating the reasons for refusal.

In order to confirm the VAT exemption of medicines supply to the customs territory of Ukraine, carried out under the agreement (contract), the supplier should submit to the Ministry of Health not later than five working days following the last calendar day of the reporting (tax) period when such operations took place, the following documents:

1) Application for a certificate confirming that the medicinal products and medical devices are paid under the agreements (contracts);

2) Appropriately certified (as required by law) copies of the following:

• agreements between the supplier and specialized organization;
• certificate of the supplier’s inclusion into EDRPOU (for a permanent representative office);
• tax invoices issued by the supplier in the course of the reporting (tax) period under the agreements (contracts) not including VAT;

3) Copy of the extract from the Register of VAT Payers.

The Ministry of Health shall issue within five working days from documents delivery the certificate of confirmation for the medicines payment under the agreements or send a written refusal notice indicating the reasons for refusal.

The supplier shall submit the confirmation certificate to the revenues and duties authority, where it is registered as a tax payer, not later than 10 working days after the deadline for submission of VAT declaration for the relevant reporting (tax) period.

The intended use of the medicinal products and medical devices exempt from VAT shall be fulfilled in accordance with corresponding legislation.