The import of dietary supplements to Ukraine: regulatory issues, international veterinary certificate
Recently, the Legal Alliance team consulted a representative in Ukraine of the United States manufacturer of dietary supplements, vitamins, generics of medicines and medical cosmetics on the import of dietary supplements to Ukraine.
The client contacted our company with a question about the list of necessary documents for the import of dietary supplements to Ukraine. This question arose due to the fact that on August 24, 2020, the Ministry of Economic Development, Trade and Agriculture of Ukraine Order No. 1329 "On Approval of Forms of International Certificates" dated July 14, 2020 (hereinafter – the "Order") came into effect. The relevant Order approved 72 forms of international certificates for supporting products of animal origin, which may include dietary supplements, during their import into Ukraine.
The legislation did not provide for a specific form of international veterinary certificate required for passing public control when importing dietary supplements, prior to the entry into force of the above Order. The import of dietary supplements to Ukraine was conducted according to the documents of the competent foreign authorities. Thus, according to the Cabinet of Ministers of Ukraine Resolution No. 960 "Some Issues of Official Control of Goods Imported into the Customs Territory of Ukraine (Including for the Purpose of Transit)" dated October 24, 2018, dietary supplements refer to goods subject to public control over compliance with legislation on food, animal by-products, animal health and welfare. This type of public control is premised on an international certificate in the original and transport documents.
At present, at the level of the Order, a specific form of an international veterinary certificate has been defined, the provision of which is required when importing dietary supplements to Ukraine. The international veterinary certificates shall be issued by the competent authority of the country of origin or of the exporting country.
The availability and content of international certificates for the import of products of animal origin into the territory of Ukraine is controlled by the State Service of Ukraine on Food Safety and Consumer Protection (hereinafter – the "State Food Safety Service").
As of the date of this writing, the State Food Safety Service recognized 50 competent authorities in the world in the field of veterinary medicine and food safety. The international veterinary certificates issued by these agencies are admissible for passing the public control of dietary supplements when imported into Ukraine.
However, in practice, there was a problem of conflict between the Ukrainian and the U.S. legislations. Thus, the Food and Drug Administration (FDA) is the competent U.S. regulatory authority for the production and export of dietary supplements, but it is not recognized by the State Food Safety Service and has no authority for veterinary certification. Another agency, the U.S. Department of Agriculture Animal and Plant Health Inspection Service (APHIS), although competent by the State Food Safety Service's definition, it is not entitled to issue supporting documents specifically for dietary supplements.
Under these circumstances, the Client applied for legal assistance due to the fact that he could not obtain the necessary documents for the import of dietary supplements into Ukraine, since none of the U.S. regulatory authorities could issue the required certificate. In other words, there was uncertainty in the legislation of Ukraine regarding a limiting list of documents and specific competent foreign authorities for their issuance.
In the course of work on the Client's instructions, the team of lawyers investigated the legal requirements, depending on the classification of goods according to the Ukrainian Classification of Goods for Foreign Economic Activity for their import to Ukraine, as well as received responses from the State Food Safety Service and the U.S. regulatory authorities based on the results of requests.
Legal Alliance has conducted a detailed analysis of the powers of the U.S. regulatory authorities and has submitted written requests to several of them. Based on the results, it was confirmed that the National Oceanic and Atmospheric Administration (NOAA) is the competent authority for issuing an international veterinary certificate for a dietary supplement, since the dietary supplements that the Client intended to import contained products of fish origin. Representatives of the State Food Safety Service have additionally confirmed that an international certificate issued by this agency can be adopted under public control of the cargo when importing dietary supplements into Ukraine.
In addition to submitting the international veterinary certificate, the manufacturer must be included in the register of countries and capacities from which the import (shipment) of goods to the customs territory of Ukraine is allowed. The register is maintained by State Food Safety Service and as of the date of the Client's request, it did not contain information about its inclusion.
We additionally investigated that the legislation of Ukraine recognizes the equivalent system of constant official control of production and circulation of products of animal origin in the EU with the system of safety and quality of food products of Ukraine. Legal Alliance has received information from the NOAA competent U.S. authority that the supplier of raw materials for the Client's dietary supplements is included in the register adopted by the European Commission. Following the results of the work, the Client received recommendations for obtaining the international veterinary certificate for the import of dietary supplements to Ukraine.
The team consisting of partner Illya Kostin and lawyer Yuliya Belinska worked on the project.
