Input 2021.02.02 20:28 | Revision 2021.02.02 20:29
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The special import system is a provision that the Ministry of Food and Drug Safety imports drugs that have not been approved or reported in the event of a national emergency such as an infectious disease epidemic. In accordance with Article 85-2 (1) of the Pharmaceutical Affairs Act, preventive and therapeutic drugs without a domestic product license may be manufactured and imported if requested by the head of the relevant department. Last year, Remdesivir also came into Korea through this special import procedure.
At the advisory meeting, experts said that the COVAX Pfizer vaccine was approved for use in major countries such as the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA), and the Korean Food and Drug Administration also participated in the WHO’s safety, efficacy, and quality evaluation as a cooperative review. Considering this, they agreed to the need for special import.
The Agency for Disease Control and Prevention said, “Today, we apply for a special import of COVAX Pfizer vaccine to the Ministry of Food and Drug Safety, and as soon as the special approval process of the Ministry of Food and Drug Safety is completed, a supply-related contract with Pfizer and UNICEF. We plan to expedite relevant administrative procedures such as delivery contracts and customs clearance,” he said.
He said, “We will continue to prepare for vaccination so that the vaccine can be vaccinated as soon as it arrives in Korea.”
Accordingly, if the supply of Pfizer vaccines such as UNICEF, which Cobax is in charge of supplying vaccines to each country, is expected to be introduced into Korea without a separate approval procedure, it is expected to be able to inoculate.
On the 30th of last month, the government received a notification that 117,000 doses of Pfizer vaccine will be supplied to Korea in the middle of this month through COVAX, a multinational alliance of global vaccine purchase and distribution. Pfizer’s vaccine is administered twice, and the initial volume is about 58,500 people.
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