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  • Penalty on 14 drug companies failed to report serialization
  • by Lee, Hye-Kyung | translator Byun Kyung A | Jun 26, 2020 06:20am
HIRA imposes administrative action on manufacturer and importer for the first time
Penalty on semi-annual shipment serialization reporting rate under 95%, serialization reporting rate under 100%
14 pharmaceutical manufacturers and importers are facing administrative actions for neglecting serialization reporting mandate.

Penalties on the nine out of 23 companies announced initially were dropped as the authority accepted their appeals.

According to the ¡®2019 Semi-annual Report on Manufacturer and Importer Subject to Administrative Penalty,¡¯ Korea¡¯s Health Insurance Review and Assessment Service (HIRA) has decided to request administrative action on 14 companies.

The penalty for violating serialization reporting mandate is imposed on pharmaceutical companies failed to meet semi-annual average shipment serialization reporting rate of 95 percent, or not complying to 100-percent serialization reportin
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