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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of December 2, 2015 No. 1153

About approval of the Procedure for import, delivery and target use of medicines, medical products and supportive applications to them which are exempted from taxation on value added

(as amended on 16-03-2022)

According to Items 38, of 38-1 subsection 2 of the Section XX "Transitional provisions" of the Tax code of Ukraine the Cabinet of Ministers of Ukraine decides:

1. Approve the Procedure for import, delivery and target use of medicines, medical products and supportive applications to them which are exempted from taxation on value added which is applied.

2. To the Ministry of Health, the Ministry of Finance to bring own regulatory legal acts into accord with this resolution in a month.

Prime Minister of Ukraine

A. Yatsenyuk

Approved by the Resolution of the Cabinet of Ministers of Ukraine of December 2, 2015, No. 1153

Procedure for import, delivery and target use of medicines, medical products and supportive applications to them which are exempted from taxation on value added

1. This Procedure determines features of import, delivery and target use of medicines, medical products and supportive applications to them which are exempted from the taxation by the value added tax which are bought by person authorized on implementation of purchases in health sector or are bought based on agreements (contracts) with the specialized organizations which conduct procurement and which are determined according to the Law of Ukraine "About public purchases" (further - the specialized organization), concluded between the Ministry of Health and the relevant specialized organization, within accomplishment of programs and implementation of centralized actions for health protection.

The term "person authorized on implementation of purchases in health sector" is used in the value given in Bases of the legislation of Ukraine on health protection.

The list of persons authorized on implementation of purchases is published by the Ministry of Health on the website in health sector which conduct procurement in the corresponding budget year.

2. Import to customs area of Ukraine in customs regime of import of medicines, medical products and supportive applications to them is performed by the companies, organizations, the organizations according to the procedure and on the conditions established by the Customs code of Ukraine, other legal acts and also in pursuance of the relevant agreements (agreements) signed by person authorized on implementation of purchases in health sector or prisoners between the Ministry of Health and the specialized organizations (further - agreements (agreements).

3. Importers of medicines, medical products and supportive applications to them (further - importers) represent to the Ministry of Health or to person authorized on implementation of purchases in health sector no later than within 10 working days about day of import to customs area of Ukraine such documents:

the statement for issue of the reference confirming import of medicines, medical products and supportive applications to them on customs area of Ukraine according to agreements (contracts) between the Ministry of Health and the specialized organization or with person authorized on implementation of purchases in health sector (further - the statement), in form according to appendix 1;

the letter obligation on import of such medicines, medical products and supportive applications to them only for their delivery on customs area of Ukraine within agreement performance (contract) between the Ministry of Health and the specialized organization or with person authorized on implementation of purchases in health sector;

the copy of the external economic agreement (contract) certified in accordance with the established procedure, one of the parties of which is the specialized organization or the winner of the procurement procedure which is carried out by person authorized on implementation of purchases in health sector, put in execution of agreements (contracts) between the Ministry of Health and the specialized organization or with person authorized on implementation of purchases in health sector according to which such import is planned;

the copy of the invoice (invoice) certified in accordance with the established procedure;

the copy of the registration certificate certified in accordance with the established procedure on medicine or the decision of the Ministry of Health which allows medicine introduction into circulation, or documents on input in turnover in Ukraine of medical products;

the copies of quality certificates (the certificates of the analysis, protocols of the analysis, etc.) issued by the producer on series of medicines which are offered to import certified in accordance with the established procedure.

4. Within five working days from the date of receipt of the documents specified in Item 3 presents of the Procedure, the Ministry of Health or person authorized on implementation of purchases in health sector issues to the importer the reference confirming import of medicines, medical products and supportive applications to them on customs area of Ukraine according to the agreements (agreements) signed between the Ministry of Health and the specialized organization or with person authorized on implementation of purchases in health sector (further - the reference), in form according to appendix 2 or provides reasonable refusal in writing.

The Ministry of Health studies documents for execution of the reference which are filed by the importers elected by the specialized organizations conducting procurement.

Person authorized on implementation of purchases in health sector processes documents for execution of the reference which are filed by the importers determined by winners by results of holding procedures of purchases, person authorized on implementation of purchases in health sector.

5. The reference is drawn up in triplicate, signed by the authorized person of the Ministry of Health or person authorized on implementation of purchases in health sector and sealed official (in case of its use). One copy of the reference remains at the Ministry of Health or person authorized on implementation of purchases in health sector, two copies are issued to the importer, one of which moves to customs authority in case of customs clearance of medicines, medical products and supportive applications to them, the second - remains at the importer.

The basis for refusal in issue of the reference are:

representation by the importer of incomplete document package, 3 presents of the Procedure specified in Item;

identification in the documents specified in Item 3 presents of the Procedure, false information.

6. In case of change of the data specified in the reference, the importer files petition in the Ministry of Health or to person authorized on implementation of purchases in health sector for issue of the new reference. At the same time earlier issued reference is subject to cancellation what the Ministry of Health or person authorized on implementation of purchases in health sector without delay informs customs authorities on.

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