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beijing news reported that on september 5, the ministry of finance issued the "notice on the "zero tariff" policy for drugs and medical devices in the hainan free trade port."

the following is the full text:

notice on the “zero tariff” policy for drugs and medical devices in hainan free trade port

hainan provincial people's government, haikou customs, state administration of taxation hainan provincial taxation bureau:

in order to support the construction of hainan free trade port, continuously expand the scope of "zero tariff" commodities, and intensify the pressure test of closed-border operation, with the approval of the state council, the "zero tariff" policy for drugs and medical devices in hainan free trade port is hereby notified as follows:

1. before the whole island is closed, medical institutions, medical colleges and universities, and medical research institutes (hereinafter referred to as relevant units) registered with independent legal personality and recognized in the hainan boao lecheng international medical tourism pilot zone (hereinafter referred to as the pilot zone) can be exempted from import tariffs and import value-added tax on the medicines and medical devices specified in article 3 of this notice and use them in accordance with the provisions of this policy.

relevant units that meet the policy conditions and import medicines and medical devices and voluntarily pay the value-added tax at the import stage may apply for it when going through the tax reduction and exemption procedures.

2. the list of relevant units that meet the policy conditions will be determined by the pilot zone management bureau in conjunction with the health, drug supervision, education, science and technology, and finance departments of hainan province, as well as haikou customs and the hainan provincial taxation bureau of the state administration of taxation, and will be dynamically adjusted and notified to haikou customs and the hainan provincial taxation bureau of the state administration of taxation in writing.

iii. the medicines and medical devices exempted from import tariffs and import value-added tax in this notice (hereinafter referred to as duty-free medicines and medical devices) include:

(1) imported drugs and medical devices that have been approved for registration in my country;

(2) according to the relevant provisions of the state council, drugs (excluding vaccines) and medical devices (hereinafter referred to as licensed drugs and medical devices) that have not yet been approved for registration in my country but are approved by the hainan provincial people’s government for import and use in the pilot zone.

4. before relevant units import duty-free drugs and medical devices, the pilot zone administration shall, together with the hainan provincial drug supervision and administration department, verify the registration certificate or relevant approval documents for each batch of imported drugs and medical devices, confirm that the imported goods of the relevant units are drugs and medical devices within the scope of policy regulations, and notify the customs and taxation departments in the locations of the relevant units in writing.

when relevant units apply to the customs in the pilot zone for tax reduction and exemption procedures, the pilot zone management bureau should refer to the current management model of licensed drugs and medical devices to manage the drugs and medical devices applying for tax exemption, and upload the relevant information to the pilot zone licensed drug and medical device traceability management platform in a timely manner to supervise the entire process of tax-free drugs and medical devices.

5. duty-free drugs and medical devices imported by medical colleges and universities and pharmaceutical research institutes that meet the policy requirements are limited to their own use within the pilot zone.

6. medical institutions that meet the policy conditions can sell tax-free drugs and medical devices to patients who receive on-site treatment at the institution based on prescriptions (doctor's orders) issued by the institution's physicians. the sales volume should meet the diagnosis and treatment needs and relevant regulations on prescription management. tax policies are implemented in accordance with the current domestic tax policy regulations.

except for the above circumstances, relevant units shall not transfer duty-free drugs and medical devices to individuals.

7. duty-free drugs and medical devices imported by relevant units that meet the policy conditions should be subject to customs supervision in accordance with the law during the customs supervision period; for duty-free drugs and medical devices sold to patients by medical institutions based on prescriptions (medical orders) issued by doctors of the institutions, customs will no longer conduct subsequent supervision as specific duty-exempt and tax-reduced goods.

8. the duty-free drugs and medical devices obtained by patients in medical institutions are final commodities for personal use and shall not be resold. they should be used within the pilot zone and shall not be taken away or mailed out of the pilot zone.

9. if the relevant units transfer duty-free drugs and medical devices due to objective reasons in accordance with relevant regulations, they should obtain the approval of hainan provincial drug supervision and administration, health and health department in advance. among them, for duty-free drugs and medical devices within the customs supervision period, the relevant units should pay the import tariffs and import value-added tax to the local customs according to regulations based on the confirmation materials of the above departments.

if relevant units violate the provisions of this notice and transfer duty-free drugs and medical devices that are within the customs supervision period, the customs will handle it in accordance with the regulations.

if a patient violates the regulations and sells tax-free drugs or medical devices again or takes or mails them out of the pilot zone, the pilot zone administration shall recover them. if they cannot be recovered, the pilot zone administration shall handle it in accordance with the regulations.

the above-mentioned transfer and sales activities shall be subject to domestic value-added tax in accordance with relevant regulations.

10. the hainan provincial people's government shall fulfill its principal responsibilities and work with the ministry of finance, the general administration of customs, the state administration of taxation, the national health commission, the national medical products administration and other departments to formulate management measures to clarify the procedures for determining relevant units that meet the policy conditions, the management requirements for duty-free drugs and medical devices, the requirements for patients to use them in the pilot zone, etc., and clarify the standards, penalties and joint punishment measures for the illegal use and disposal of the above-mentioned goods by relevant units and the illegal sale, removal and delivery of the above-mentioned goods by patients. the management measures shall be issued and implemented simultaneously with this notice.

11. from the implementation of the policy, the hainan provincial people's government shall organize regular comparisons of the import, sales and use of duty-free drugs and medical devices, and strengthen the management and supervision of the use and disposal of duty-free drugs and medical devices (including prescriptions (medical orders) issued by doctors in medical institutions) by relevant units that meet the policy conditions, promptly investigate and deal with illegal and irregular acts, and report the implementation status to the issuing unit of this notice every three months, including the basic information of relevant units that meet the policy conditions, the import and sales of duty-free drugs and medical devices by each unit, and tax exemption data.

the relevant departments of hainan province should improve the functions of the traceability management platform for licensed drugs and medical devices in the pilot zone, upgrade and transform the technical system to meet the needs of duty-free drug and medical device management. at the same time, they should strengthen information interconnection and interoperability, share information on relevant units, patients, and duty-free drugs and medical devices that meet the policy conditions, strengthen supervision, and prevent and control risks.

12. the people's government of hainan province shall strengthen supervision and inspection on the implementation of this policy to prevent illegal and irregular behaviors, and report relevant situations to the issuing unit of this notice in a timely manner.

13. any violation of this notice that constitutes reselling, purchasing on behalf of others, smuggling of duty-free drugs and medical devices, or violation of customs supervision regulations shall be handled by the customs in accordance with relevant regulations; the pilot zone administration shall include it in the credit record in accordance with relevant regulations, and the patient shall not purchase duty-free drugs and medical devices within three years. if it constitutes a crime, criminal liability shall be pursued in accordance with the law.

14. if relevant units or doctors violate regulations in using or disposing of duty-free drugs and medical devices, they shall be dealt with in accordance with relevant regulations. if the relevant units are held criminally liable in accordance with the law, this notice shall cease to apply, and the pilot zone management bureau shall notify haikou customs and the hainan provincial taxation bureau of the list and the start time of cessation of application.

15. this notice is only applicable in the hainan boao lecheng international medical tourism pilot zone and will be implemented from the date of publication.

editor: liu jiani