Amid growing coronavirus cases from the latest outbreak in the country, the Vietnamese government is taking measures to speed up the vaccine rollout for its population. The government has approved the establishment of a COVID-19 vaccine fund, which will receive, manage, and use voluntary financial and vaccine donations and assistance from domestic and foreign organisations and individuals, for vaccine procurement and import, research and production in Vietnam, and distribution of vaccines for the people.
One of Vietnam’s goals for prevention of the spread of the pandemic is to have 75 per cent of its population vaccinated by the end of this year, which would require about 150 million doses of vaccines, as explained by Minister of Health Nguyen Thanh Long. This would cost more than $1 billion, and the fund is in place to mobilise the resources for that goal.
Towards that goal, the government encourages all localities and businesses to seek proper vaccine resources and negotiate with vaccine manufacturers for the purpose of import into Vietnam. Of course, there are rules and policies to follow for import and distribution of such vaccines in Vietnam.
Under the Law on Pharmacy and its guiding regulations, only certain companies that are duly licensed with the business lines of pharmacy import and/or trading, and have valid certificates of eligibility for pharmacy business can import vaccines into Vietnam. To obtain a certificate of eligibility for pharmacy business, a company must have the premises, drug storage, storage equipment, transportation means, quality control system, technical documents, and qualified personnel that meet the requirements as specified the pharmacy law, as well as in Decree No.54/2017/ND-CP as amended by Decree No.155/2018/ND-CP from 2018, and Circular No.36/2018/TT-BYT, from the same year, regulating good storage practices of drugs and drug materials.
As published by the Ministry of Health (MoH), 36 companies have been licensed and are eligible to import and trade these vaccines in Vietnam. Localities and businesses who have been approached with supply resources must cooperate with the MoH or one of these licensed companies for the purpose of importation of vaccines.
Those foreign-invested enterprises (FIEs) which have been granted the import rights in their investment registration certificate can act as the import of the vaccines for wholesale to authorised Vietnamese companies, but such enterprises shall not be permitted to distribute vaccines as regulated in 2013’s Circular No.34/2013/TT-BCT publicising roadmaps for goods trading and directly related activities of FIEs in Vietnam.
Per Article 60 of the Law on Pharmacy, vaccines with a valid marketing authorisation granted by the MoH can be imported with a volume to satisfy the demand by eligible companies without an import permit. Commonly, it takes from 6-12 months to obtain a marketing authorisation for a vaccine. However, the MoH has announced that according to warnings from the World Health Organization (WHO), a clinical trial which is one of the requirements for imported vaccines will not be required, but will be based only on an application dossier, which may take about 48 hours.
That means the time for the procedure for granting a marketing authorisation for vaccines will be drastically shortened.
In addition, the MoH is considering on an urgent basis the issuance of a new circular on registration of COVID-19 vaccines under summary procedure for response to the emergency pandemic situation, which will facilitate localities and businesses in import of vaccines into Vietnam.
Also in accordance with Article 60 of the Law on Pharmacy, in certain cases, vaccines which have not yet been granted marketing authorisation by the MoH can be imported into Vietnam with relevant importation permits granted on a case-by-case basis by the MoH.
These permits have a duration of one year from the issuance date and are limited to stated volumes of vaccines to be imported.
In response to the current situation of pandemic, the MoH will base on Article 60 of the Law on Pharmacy and Article 67 of Decree 54 to consider and grant conditional approvals of certain vaccines for the emergency use.
Accordingly, the ministry will examine and grant import permits within about five working days for those vaccines already approved by the WHO, or within about 10 for those vaccines which have not yet been approved but have been approved in other countries.
To date, the MoH has approved import of three vaccines for emergency use: AstraZeneca, Sputnik V, and COVID-19 (Vero Cell) Inactivated.
By Nguyen Thi Hong Anh and Ly Nghia Dzung Indochine Counsel
