1. Job purpose
Standardize the procedures for health quarantine approval of special items entering and exiting the country, improve work efficiency, clarify relevant responsibilities, strengthen supervision and management, and ensure the effective implementation of health quarantine approval for special items.
2. Applicable scope
This work standard is applicable to the application, acceptance, review, decision, and approval form issuance of health quarantine approval work for special entry-exit items as stipulated in Article 11 of the Implementation Rules of the Frontier Health and Quarantine Law of the People's Republic of China.
3. Responsible department
The health and quarantine approval work for entry and exit special items shall be implemented by the health inspection offices of each directly affiliated inspection and quarantine bureau, and a dedicated person shall be designated to be responsible. A work position responsibility system shall be established based on the principle of "acceptance, review, and decision" separation and authority division.
Job responsibilities are shown in Figure 1.
4. Work Procedure
4.1 Application materials
The applicant for health quarantine approval of special items for entry and exit (hereinafter referred to as the applicant) shall download and fill out the "Application Form for Health Quarantine Approval of Special Items for Entry and Exit" (hereinafter referred to as the "Approval Application Form") from the official website of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China or relevant directly affiliated bureaus (in duplicate, see Annex 1), and provide relevant supporting materials (one for each). Applicants for special items entering the country should submit their applications to the inspection and quarantine bureau directly under the jurisdiction of the port of entry within 3-10 working days before the entry of the special items; Applicants for exit special items should submit their application to the inspection and quarantine bureau directly under the place of origin within 3-10 working days before leaving the country.
The following materials should be provided when applying:
1. To apply for the approval procedures for entry and exit microbiology, human tissue, and blood hygiene quarantine, the following materials should be provided:
(1) Certificate of Entry and Exit Permit issued by relevant competent authorities (original and photocopy):
① The following situations require a permit for entry and exit issued by the Science and Education Department of the Ministry of Health:
Exit of medical special items from a large sample (over 100 people, including 100 people) that do not involve human genetic resources;
Large sample (over 100 people, including 100 people) of medical special items entering the country;
- The entry and exit of medical special items that contain or may contain 3-4 levels of pathogenic microorganisms;
Entry and exit of medical special items originating from epidemic areas;
- Entry of medical special items in the international multicenter clinical research project of new drugs;
Exit of medical special items that involve a family or specific region, but do not involve human genetic resources.
② The following situations require a permit for entry and exit issued by the local health authority:
Exit of medical special items for small samples (less than 100 people) that do not involve family, specific regions, and human genetic resources;
- Entry of small samples (less than 100 people) of medical special items;
- The entry and exit of medical special items that contain or may contain Class 1-2 pathogenic microorganisms;
- The entry and exit of individual or several medical special items (such as bone marrow, umbilical cord blood, cornea, blood, urine, etc.) used for humanitarian donations, rescue or disease diagnosis;
-- Entry and exit of medical research samples such as cell lines, biological products, biochips, cloned human cell tissues, etc.
③ The following situations require a permit for entry and exit issued by the Office of Human Genetic Resources Management:
The exit of human substances involving human genetic resources.
④ The following situations require a permit for entry and exit issued by the national food and drug regulatory authority:
The entry of microorganisms, human tissues, and blood used for food and drug production.
⑤ The following situations require a permit for entry and exit issued by the corresponding competent department of the State Council:
Used for the entry and exit of microorganisms, human tissues, and blood in other fields.
(2) Explanatory documents on the scientific names (in Chinese and Latin) and biological characteristics (in both Chinese and English) of pathogenic microorganisms contained in special items;
(3) Entry special items that contain or may contain 3-4 levels of pathogenic microorganisms, as well as entry special items that contain or may contain unclassified pathogenic microorganisms, the user unit should have a BSL-3 level (P3 level) laboratory and provide proof of corresponding laboratory qualifications;
(4) Special items for scientific research should provide the original approval documents for scientific research projects or agreements between the applicant for scientific research projects and domestic and foreign cooperative institutions (original and copies in both Chinese and English);
(5) Organs for transplantation should provide a qualified hospital's health certificate and relevant inspection reports from the donor.
2. To apply for the health quarantine approval procedures for entry-exit biological products and blood products, the consignor or its agent shall provide the following materials:
(1) Imported biological products and blood products used for treatment, prevention, and diagnosis shall provide an import registration certificate issued by the national drug regulatory department; (Imported biological products used in medical clinical trials must submit clinical trial approval documents issued by the national drug regulatory department)
(2) For outbound biological products and blood products used for treatment, prevention, and diagnosis, a "Drug Sales Certificate" issued by the national drug regulatory department should be provided
Ming;
(3) For entry and exit biological products and blood products used in other fields, import approval documents issued by relevant competent departments should be provided.
4.2 License conditions
For non infectious or controllable use of entry and exit special items that contain or may contain pathogenic microorganisms, relevant proof materials are complete and comply with legal forms.
4.3 License Period
4.3.1 Make a decision to approve or disapprove the permit within 20 working days. If a decision cannot be made within 20 working days, an extension of 10 working days may be granted with the approval of the person in charge, and the applicant shall be informed of the reasons for the extension.
4.3.2 For special items and high-risk biological products that have not yet been recognized for their infectivity, Beijing, Shanghai, and Guangdong bureaus are currently designated to carry out technical analysis work and issue a "Technical Analysis Report". The time required for technical analysis is not included in the approval period, but should be notified in writing to the shipper or their agent. If the organ for transplantation has not gone through the health and quarantine approval procedures due to special reasons, the inspection and quarantine institution may release it at the time of entry or exit. The owner or his agent shall apply for the completion of the health and quarantine approval procedures within 10 days after the release. The procedures for health quarantine approval of special items for entry and exit include application, acceptance, review, decision, issuance, etc.
