Would Vietnamese enterprises be allowed to import Covid-19 vaccine?
The impact of COVID-19 has spurred the world's scientific community's efforts in understanding, developing and providing new vaccines to control the raging pandemic. Currently, Vietnam has not been able to produce a Covid-19 vaccine, so importing vaccines from countries around the world is extremely necessary. So, are Vietnamese businesses allowed to import Covid-19 vaccines? How to apply for a license to import Covid-19 vaccine? Within the scope of the article, DTD will analyze and give a clearer legal perspective for readers on this issue.
1. Conditions for Vietnamese enterprises to import Covid-19 vaccines
In order to be licensed to import Covid-19 vaccine, first of all, in the business line of the Enterprise, there must be a business related to imported goods. In addition, the enterprise also needs to have a certificate of eligibility for pharmaceutical business with the scope of vaccine import and vaccine preservation business.
In Vietnam, there are currently 36 enterprises across the country that have been granted the Certificate of eligibility for pharmaceutical business with the scope of vaccine import and vaccine preservation business (as of May 13, 2021).
Any enterprise that has access to a source of Covid-19 vaccine can import it, but it must meet the above conditions and must follow the process specified in Section 2 below.
2. Process and procedures for importing Covid-19 vaccine
Enterprises carry out the procedures for applying for a license to import vaccines at the Drug Administration of Vietnam and the procedures for applying for a certificate of ex-warehousing at the National Institute for Inspection of Vaccines and Medical Biologicals.
* Procedure for applying for the Certificate of Ex-works of the vaccine
When carrying out procedures for importing vaccines into Vietnam, units urgently send quality documents as prescribed (including: Certificate of ex-works from the manufacturer and/or Certificate of quality from the regulatory agency). management) for the National Institute for Inspection of Vaccines and Medical Biologicals (NICVB) to issue the Certificate of Ex-works within 48 hours as recommended by WHO to ensure quality and avoid importing vaccines of unknown origin. .
* The process of applying for a license to import vaccines
Step 1: Enterprises prepare documents as prescribed in Article 67 of Decree 54/2017/ND-CP and Decree 155/2018/ND-CP, including:
- An application for export of vaccines;
- Vaccine certificate; or Certificate of the competent authority of the exporting country on the circulation of vaccines in at least 01 country in the world.
- Written request or approval of the Ministry of Health.
Step 2: The Drug Administration of Vietnam reviews and approves the application. For vaccines approved by the World Health Organization (WHO) for emergency use (from manufacturing facilities: AstraZeneca, Pfizer, Moderna, Sinopharm, Johnson & Johnson...), the Ministry of Health The World Health Organization will consider and approve it within 5 working days upon receipt of all legal and valid documents and the official authorization of the COVID-19 vaccine manufacturer.
For vaccines that have been approved by other countries but have not been approved by WHO for emergency use, the Ministry of Health will review and approve them within 10 working days upon receipt of sufficient legal documents. valid and accompanied by the official authorization of the facility manufacturing the COVID-19 vaccine.
Currently, in the list of 36 eligible enterprises, no Vietnamese enterprises have imported Covid-19 vaccines. However, in the spirit of Official Letter 4433/BYT-QLD, it is highly recommended that corporations and businesses access the source of the covid-19 vaccine to have the fastest, earliest and widest source of vaccine used for the Vietnamese people. . Therefore, in order to join hands to share the burden with the state, it is necessary for businesses to find and import Covid-19 vaccines.
