Procedures for issuance of Licenses for Tissue Bank Operation in Vietnam

According to Article 4 of Decree No. 56/2008/NĐ-CP and Clause 5 Article 1 of Decree No. 118/2016/NĐ-CP of Vietnam’s Government, the application for Operation License includes:

- An application form for Operation License;

- A certified true copy or copy enclosed with the original copy for collation of the Establishment Decision or competent authority's documents named the tissue bank in the organizational structure of the medical facilities in case of State-owned tissue banks; or Enterprise Registration Certificate in case of private tissue banks;

- A list of facilities and medical equipment as proof of fulfillment of requirements;

- A List of employees as proof of fulfillment of requirements. For tissue bank professional managers, the certified true copies of disciplinary degrees and certificates, employment verification, health certificate, profile and criminal record are required.

The issuance of a license is carried out according to the following steps:

Step 1: Submitting application

Any entity wishing to be granted the Operation License shall submit an application for Operation License to the Ministry of Health directly or by post.

Step 2: Receiving application and establishing the Evaluation Board

Within 05 working days after the receipt, the Ministry of Health shall examine the validity of such application. In case the application is found invalid, the Ministry of Health shall instruct the applicant to complete the application.

Within 05 working days from the date of receipt of the valid application, the Minister of Health shall issue the Decision on Establishment of Evaluation Board for issue of Operation License.

Step 3: Conducting the evaluation

Within 20 working days from the date of issue of the Decision on Establishment of Evaluation Board, the Evaluation Board shall carry out a site inspection at the tissue bank, and submit the inspection record and inspection report to the Minister of Health thereafter.

Step 4: Licensing

Within 05 working days from the date of receipt of the inspection record, the Minister of Health shall issue the Operation License using the specimen in Annex III attached hereto to the tissue bank In case of rejection, the Ministry of Health shall inform the applicant and provide explanation in writing.

Words explanation

- Tissue is a combination of cells of the same type or different types to perform certain functions of human body.

- Tissue bank is an establishment that receives, preserves, stores, transports and supplies tissues that is organized under one of two following forms:

+ Tissue banks that are affiliated to State-owned or private medical facilities, Medical Universities, Universities of Medicine and Pharmacy or National Coordination Center for Human Organ Transplantation;

+ State-owned or private tissue banks that are independent from other organizations.

Nguyen Trinh

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