Vaccine registration license. Bac Viet Luat will consult legal procedures on applying for health license for our customers. We will supply

following services and contents of work that our lawyers commit to carry out:

Documents need to be registered

Documents on registering semi-finished vaccines, semi-finished medical products include:

1 Normal 0 MicrosoftInternetExplorer4 .Application for registration2. Certificate of production facilities that meet the standards of GMP by competent state agencies issued3. Certificate of competent state agencies, in which allows to circulate or export medical products4. Certificate or copy of certificate of national verification agencies in other countries, in which semi-finished products registered are sold and distributed. In case there are no national verification agencies in these countries or the first time products have been exported to foreign countries, all these things must be showed clearly.5. Certificate of the result of vaccines verification, semi-finished medical products by Center of National Verification of Vietnam medical products issued6. Manufacturing and verifying process7. Standard of quality and verification8. Documents on:

• Origin and history of original bacteria, viruses
• Related documents on copyright and manufacturing certificate application
• Report on the most recent manufacturing situation

9. Documents on stabilities: Verifying result by Department of verifying manufacturing facilities of three lots of successive semi-finished products10. Label is official form that applies for circulation, direct label on the smallest package unit, indirect label on the packing and attached using direction paper11. Form of vaccines, medical products: stores at Center of National Verification of Medical products

Documents on vaccines, medical products registration for prevention and treatment of diseases include:

1. 1. Above mentioned documents ( from 1 to 11) and;
2. 2. Result of clinical trying that meets quality standard of Vietnam ( for products first used in Vietnam)

Documents on registration of finished product and medical product to diagnose:

1. 1. Procedures mentioned in 1,2,3, 5, 6, 7, 11 sectors and;
2. 2. Summary report on introducing process and research result, attaching to research documents on following problems:
   • Composition
   • Effect, using direction
   • Stability and the way of preservation
   • The result of experiment

The order of procedures

1. 1. Enterprises which want to register product manufacture and circulation in Vietnam have to send vaccines registration document, medical products as the above regulations for each kind of vaccines, medical products to Vienam standby health department ( under the Ministry of Health). Document on registration includes above regulated procedures.
2. 2. Vietnam Standby Health Department is a permanent body of appraisal council of registration of vaccines and medical products( Minister of Health will appoint this council), and is a body that has a right to consult Minister of Ministry of Health about considering and appraising registration documents.
3. 3. Within 3 months from the date of receiving complete documents as regulation, Minister of Ministry of Health will decide to issue registration code on the base of conclusion and proposal of appraisal council of registration of vaccines and medical products.
4. (Bac Viet Luat LawFirm)

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