Provision of medicines, medical devices and other humanitarian aid for Ukraine

As of April 2024, at least 1,700 healthcare institutions have been damaged in Ukraine, and about 200 of them have been completely destroyed. It is not just the medical infrastructure that has been affected, the war causes high civilian casualties every day and forces people to move within and outside the country. Many international organizations, enterprises and individuals want to support Ukraine in this struggle and send it humanitarian aid. We express our sincere gratitude for your support, which is extremely valuable and lifesaving in the extremely difficult period of development of our country. The following information is intended to facilitate for all interested parties the process of sending, delivering and receiving charitable aid for Ukraine, primarily medical products – medicinal products, medical devices, etc., and is updated as of April 2024. The following information is relevant specifically for humanitarian aid, which is defined by current legislation exclusively as non-returnable and free of charge, i.e. such that does not provide for monetary, material or other compensation to donors.

General information

During the period of martial law, the usual Procedure for customs clearance of humanitarian aid cargoes, approved by Resolution No. 544 of the Cabinet of Ministers of Ukraine (hereinafter – CMU)  dated 03/22/2000, does not apply. In accordance with Part 7 of Art. 15 of the Law of Ukraine dated 10/22/1999 No. 1192 “On Humanitarian Aid” for the period of martial law, the CMU has the right to recognize certain categories of goods as humanitarian aid without carrying out the procedure for recognizing such goods as humanitarian aid in each specific case. This simplification – the introduction of the declarative principle, was previously implemented by the CMU Resolution No. 174 dated 03/01/2022 and was aimed at speeding up the process of providing aid to Ukraine, but it also had another side – reporting in the usual form was not carried out. Accordingly, aid recipients could not confirm its intended use, which could lead to abuse in the use of the provided humanitarian aid.

To settle this issue, a new resolution of the Cabinet of Ministers of Ukraine dated September 5, 2023 No. 953 (hereinafter – Resolution No. 953) was recently adopted, which entered into force on 12/01/2023 and superseded the CMU Resolution No. 174 dated 03/01/2022.

Recognition of goods that cross the customs border of Ukraine as humanitarian aid is a key condition for exemption from value added tax and import duty. In addition, humanitarian aid is currently not subject to non-tariff regulation measures. Thus, the procedure for importing humanitarian aid is maximally simplified. Also, for the import of humanitarian aid from foreign donors, it is currently not required to provide quality certificates, obtain special permits, and the goods may not contain labeling in the Ukrainian language.

Both a legal entity and an individual can become a donor.

Import of humanitarian aid to Ukraine

Medicinal products, medical devices, biocides, cosmetic and hygiene products provided in the form of humanitarian aid are imported into Ukraine according to the same declarative principle as other goods, therefore, during martial law, they are not subject to state registration and are not objects of state quality control.

In order to avoid abuses during the importation of humanitarian aid, Resolution No. 953 provides for the digitization of the related processes, namely the registration on the electronic platform of the recipient of humanitarian aid who plans to import cargo. With the help of the web platform “Automated system of registration of humanitarian aid” (hereinafter referred to as the “Automated system”), organizations planning to import humanitarian aid will be able to register on the website, form and submit a declaration on the list of goods that are defined as humanitarian aid. The declaration can be created in electronic form and submitted to the customs authority through information interaction or printed out together with a unique electronic identifier (QR code, bar code, digital code, etc.) for submission to the customs authorities in paper form. According to this code, customs officers will pass the cargo. Submission of a declaration without a unique humanitarian aid code after 04/01/2024 is not allowed!

The list of goods declared in the declaration must correspond to the list of goods entered into the Automated System under the corresponding unique code of humanitarian aid by categories and names of goods, number of seats, number of pieces and weight/volume. If the data specified in the declaration do not correspond to reality, the passage of such humanitarian aid to the territory of Ukraine will be refused.

Medicinal products and medical devices must be transported in conditions that ensure proper storage, integrity, quality and protection from environmental factors (light, moisture, dust, temperature, etc.).

The import of humanitarian aid into the territory of Ukraine according to the declaration is allowed within 30 calendar days from the date of its creation. Goods, information about which is entered into the Automated System under the corresponding unique code of humanitarian aid and which are not imported into the territory of Ukraine within 90 calendar days from the date of assignment of the unique code of humanitarian aid, automatically lose the status of goods recognized as humanitarian aid.

Resolution No. 953 also allows making changes to the declaration only before submitting it to the customs authority at the checkpoint across the state border of Ukraine. From the moment the declaration is accepted by the customs authority, it is a document certifying facts that have legal significance.

Prohibited goods for import

It should be borne in mind that there are groups of goods that are prohibited for import into the customs territory of Ukraine, in particular:

1. Goods originating from the territory of russia are specified in the list in the Appendix to the resolution of the Cabinet of Ministers of Ukraine No. 1147 dated 12/30/2015. This ban is established until December 31, 2024, inclusive, but may be extended for the next period by the decision of the authorities.
2. Narcotic, psychotropic, potent poisonous drugs.
3. Goods imported in violation of intellectual property rights.

Narcotic drugs, psychotropic substances and precursors as humanitarian aid, which Ukraine also needs for the proper provision of health care in conditions of martial law, can only be obtained by authorized state institutions specified by the Order of the Ministry of Health of Ukraine dated 03/12/2022 No. 474.

In the case of the importation of humanitarian aid by volunteers who do not have a registered legal entity, the rules and restrictions established by the current legislation of Ukraine for citizens apply to them.

Reporting

Reporting for received humanitarian aid is done by filling out and submitting a report and/or inventory description of humanitarian aid.

Budget institutions, except those under the control of the Ministry of Health of Ukraine, must report within 15 days from the moment of customs clearance of humanitarian aid. Recipients of medical humanitarian aid — within 60 days from the moment of customs clearance of humanitarian aid. In other cases, no later than 90 days after customs clearance of humanitarian aid. If the report is not submitted within the specified period, the humanitarian aid will be considered as unaccounted for receipt and intended use and misused. The report on received humanitarian aid is submitted by the 15th of each month.

Transition period

To facilitate adaptation to the new procedure, Resolution No. 953 provides for a transitional period, from 12/01/2023 to 04/01/2024, during which the organization can use the usual method of submitting a declaration or start using the Automated System. The content of the paper declaration does not differ from its digital version. The recipient of humanitarian aid, in such a case, must upload to the specified system a copy of the paper report on the distribution and use of humanitarian aid in the form established by Resolution No. 953. It should be borne in mind that aid imported without providing a corresponding report through the Automated System is considered to have been used not as intended!

Responsibility

Resolution No. 953 also provides for responsibility for violations of humanitarian aid legislation by recipients. Therefore, the organization loses the status of recipient of humanitarian aid from the moment its account in the Unified Register is blocked in order. Such blocking is carried out:

• automatically if the recipient has not submitted a report within 90 calendar days from the date of customs clearance of humanitarian aid according to the declaration, or if the recipient, who declared humanitarian aid and did not distribute it in full, does not submit a report indicating current information on the availability of humanitarian aid within 90 calendar days days in a row;
• the administrator of the Automated System if he has a court decision on the recipient’s violation of the legislation on humanitarian aid that has entered into force, official information on the liquidation of the legal entity that is the recipient, an application to exclude the recipient from the Register, or in the case when the recipient does not meet the requirements for persons who may be recipients of humanitarian aid in accordance with the Law “On Humanitarian Aid”.

If the recipient violates the reporting conditions for the first time, such a recipient loses the status of recipient of humanitarian aid for three months, with the possibility of renewal if the required report is submitted in the Automated System within a month from the date of blocking. In case of repeated violation, renewal in the Register is possible only after 6 months.

Documents in the Automated System: the report, inventory description and copies of primary documents are freely available and free of charge (except for documents of military administration bodies).

Storage and accounting of medical products

It is allowed to store medicinal products in warehouses that do not have an appropriate license, but with mandatory compliance with the storage conditions specified by the manufacturer.

In order to account for aid from a foreign donor, the recipient, in addition to the above-mentioned act of acceptance and transfer, needs a customs declaration and a waybill. The accounting and control over the receipt and use of such goods is carried out on the basis of reports received in accordance with Article 11 of the Law of Ukraine “On Humanitarian Aid” dated 10/22/1999 No. 1192-XIV.

Note that it is the end user of humanitarian aid goods who performs incoming control measures and accounting for the received goods. He is responsible for the quality and safety of goods received as humanitarian aid. The receipt and distribution of medicines, other medical goods and medical equipment in Ukraine is carried out by the state institution “Public Health Center”, which is included in the Unified register of recipients of humanitarian aid and ensures its distribution among hospitals, other institutions and organizations.

On the basis of the letter of the State Service of Ukraine for Medicinal Products and Drug Control No. 1655-001.1/004.0/17-22 dated 03/01/2022, during the period of martial law in Ukraine, holders of licenses for conducting business activities in the wholesale trade of medicinal products may supply medicinal means to entities that do not have pharmaceutical licenses or medical practice licenses. In particular, medicinal products can be supplied to military administrations, units of the military forces of Ukraine and legal entities that carry out volunteer activities and provide humanitarian aid. This does not include medicinal products, the circulation of which is carried out with a license for the circulation of narcotic drugs, psychotropic substances and precursors, as well as potent, poisonous and radioactive medicines.

How to offer help for Ukraine

If you want to help, but do not know a specific recipient for the help you can offer to Ukraine, we advise you to visit the official humanitarian aid portal and the HELP UKRAINE CENTER humanitarian fund.

The official humanitarian aid portal publishes current information on needs, including the needs of the Ministry of Health, hotline telephone numbers, interactive instructions for applying for humanitarian aid and addresses for sending to logistics centers in Poland, Portugal, Romania, Slovakia, Hungary, Sweden and Italy are provided.

HELP UKRAINE CENTER is a humanitarian fund that cooperates with the Ministry of Health of Ukraine and the Ministry of Reintegration of the Temporarily Occupied Territories of Ukraine, has warehouses in Chelm, Poland, organizes logistics for the delivery of humanitarian goods to Ukraine and collects funds for their independent purchases You can send medicines, medical products and equipment, cosmetics and hygiene products in several ways indicated on the organization’s website, including postal carriers. HELP UKRAINE CENTER also accepts prescription and potent drugs with restrictions on their circulation.

 Ihor Yurchenko, Alla Somyk,
Maksym Lovkin, Maksym Bagrieiev
Cratia