Some businesses are still unclear on the rules on the importation, trading, and preservation of COVID-19 vaccines. Can you walk us through the licensing and import procedure?
|Vu Tuan Cuong, director of the Drug Administration of Vietnam under the Ministry of Health |
At present, the National Regulatory Authority (NRA) of Vietnam has achieved Maturity Level 3, the second-highest level in the World Health Organization’s (WHO) 4-level rating for vaccine regulation. The announcement of the list of units qualified to import COVID-19 vaccines on the website of the Drug Administration of Vietnam (DAV) is in line with WHO guidelines.
The licensing and import of COVID-19 vaccines is guided by Dispatch No.4433/BYT-QLD of the Ministry of Health (MoH) that was sent to municipal and provincial people’s committees, manufacturers and importers, as well as businesses and organisations having sources of vaccine supply. In this latest document, the MoH once again encourages localities, groups, businesses, and individuals who are able to access COVID-19 vaccines, committing to create the most favourable conditions and procedures for importation.
To assist the MoH in this, the ministry suggests that while negotiating contracts with manufacturers or suppliers, qualified units keep in mind several issues.
Regarding vaccines already approved by the WHO for emergency use (manufactured by AstraZeneca, Pfizer, Moderna, Sinopharm, Johnson & Johnson, and others), the MoH will issue approval in five working days since receiving a complete dossier of documents and official authorisation from COVID-19 vaccine manufacturers.
Applications for other vaccines that have been approved by other countries but not the WHO for emergency use will be considered within 10 working days.
An application to import vaccines into Vietnam should include the Factory Certificate of manufacturers or the Quality Certificate from management authorities so that the National Institute for Control of Vaccines and Biologicals can grant the Factory Certificate within 48 hours as recommended by the WHO to ensure the quality.
For qualified localities and units, the ministry will create the most favourable conditions for importation and verification, while supporting them in administrative procedures to ensure speed, safety, and efficacy.
Earlier, the DAV issued Document No.406/QLD-KD dated January 27, Document No.1438/QLD-KD dated February 23, and Document No.2511/QLD-KD on March 22 encouraging groups and businesses to fast-track the access of COVID-19 vaccine supplies.
Is the MoH actually able to license the import of COVID-19 vaccines in 5-10 working days to valid applications?
Definitely. If cities and provinces, groups and businesses, or others who can approach COVID-19 vaccine supplies and want to import them to Vietnam provide sufficient legal documents, the MoH will grant a license in this timeline.
At present, all processes related to the licensing and importation of COVID-19 vaccines have been maximally shortened by the ministry to create the most favourable conditions for all stakeholders.
Once again, we want to warn organisations, individuals, and localities to make sure suppliers and manufacturers can produce sufficient certificates of origin and quality before beginning importation procedures. This will prevent fraud and save them time and costs on applications that would be eventually refused by the MoH.
What are the possible ways to import COVID-19 vaccines to Vietnam?
To approach COVID-19 vaccines as soon as possible and diversify supply lines, the DAV has been granting import licenses and acts as an advisor to the leaders of the MoH in the approval of vaccines for emergency use in a quick and transparent manner. The process is implemented in line with the prevailing rules, ensuring quality, safety, and efficacy.
There are two ways diplomatic organisations, localities, groups, and businesses can import COVID-19 vaccines into Vietnam.
Diplomatic organisations and consulates need to follow Article 75 of Decree No.54/2017/ND-CP dated 2017, guiding the licensing of non-commercial import of drugs in line with the Law on Pharmacy. All other stakeholders need to follow Article 67 of Decree 54 on licensing the importation of drugs to meet the urgent need of national defence and security, epidemic control, or disaster relief. Applications need to include three copies of the purchase order, the original or a certified copy of the pharmaceutical product (or a confirmation to that effect from the competent authorities of another country), and the original or a certified copy of a document specifying the active ingredients, dosage, concentration, packaging instructions, and the origin of the manufacturer.
Up till now, the DAV has dealt in time with all import orders of COVID-19 vaccines from the COVAX Facility and AstraZeneca Vietnam while giving instructions to diplomatic organisations on the submission of documents for non-commercial import procedures under Article 75.
We have submitted for approval for emergency use vaccines from AstraZeneca, Sputnik V, and Sinopharm. On June 7, the Advisory Council for the Grant of Circulation Registration Numbers for Drugs under the MoH approved the COVID-19 vaccine of Pfizer. The DAV now proposes qualified businesses to submit documents related to other COVID-19 vaccines manufactured by Moderna, Johnson & Johnson, and others so that the Council can consider approving them.
We have been directly working with localities and businesses on this while providing consultancy on import procedures and are awaiting news of new import orders.