Let me ask, what is the procedure for requesting an import license for disease specimens? What does the application dossier include? This is a question from Mr. Nguyen Quan Truong in Da Nang.
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Procedures for applying for an import permit for specimen samples (Illustration)
Regarding this issue, THU KY LUAT editorial board provides the following clarification:
According to the guidance in Decision 433/QD-BYT announcing administrative procedures in the field of preventive medicine under the management of the Ministry of Health, promulgated on January 31, 2019, the procedure for applying for an import permit for specimen samples is stipulated as follows:
1. Procedure for applying to import specimen samples
Step 1. The facility applying for an import permit for specimen samples submits the application directly or via postal service to the Department of Preventive Medicine, Ministry of Health according to Form No. 25 in the Appendix issued together with Decree 155/2018/ND-CP on November 12, 2018.
Step 2. In cases where there are no requests for amendment or supplementation of the application, the Department of Preventive Medicine, Ministry of Health will issue the import permit for specimen samples within 15 days from the date noted on the receipt of the application.
Step 3. In cases where there is a request for amendment or supplementation, the Department of Preventive Medicine sends a written notification to the facility to request amendment or supplementation of the application within 10 days from the date noted on the receipt of the application. Within 30 days from the date the Department of Preventive Medicine issues the notification for amendment or supplementation, the facility applying for the import permit must submit revised or additional documents as requested. After this period, if the facility does not amend or supplement the application, the process for importing specimen samples must be restarted from Step 1;
Step 4. In cases where the revised or additional documents do not meet the requirements, the Department of Preventive Medicine, Ministry of Health will issue a written notification to the facility as per Step 2. If there are no requests for amendment or supplementation for the revised or additional documents, the Department of Preventive Medicine, Ministry of Health will issue the import permit for specimen samples as stipulated in Step 1.
2. Method of execution
Submit the application for importing specimen samples via postal service or directly at the Department of Preventive Medicine.
3. Application for importing specimen samples
- Components of the application include:
- A written request for importing specimen samples according to the prescribed form in Form No. 25 issued together with Decree 155/2018/ND-CP;- A copy of the decision approving the research project or study, still valid, by the competent authority or a copy of the approved research proposal or project document or a copy of the valid agreement or related documents between domestic and foreign facilities regarding the import of specimen samples;- A copy of the self-declaration of meeting biosecurity standards for biosecurity level 1 or 2 laboratories or a biosecurity certificate for biosecurity level 3 laboratories.
- Number of applications: 01 (set).
4. Time limit for resolution:
The time limit for resolution is 15 days from the date of receipt of a valid application.
Download Form No. 25 Request for Import of Specimen Samples HERE.
Hai Thanh
