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  • Grace period for foreign API mfg site registrations ends
  • by Lee, Hye-Kyung | translator Alice Kang | Jan 19, 2023 05:58am
and registration becomes mandatory from the 21st
MFDS seeks to improve drug quality...will start registration of foreign manufacturing sites for imported drugs
Starting on the 21st, the foreign manufacturing site for all pharmaceuticals (including APIs) imported to Korea from abroad must be registered in advance.

The Ministry of Food and Drug Safety announced that the grace period that had been granted in consideration of the industry¡¯s state of preparations in registering foreign manufacturing sites for APIs imported to manufacture of finished products, will end as of January 20th.

The mandatory registration of overseas manufacturing sites for all pharmaceuticals went into effect on July 21st last year after the amendment of the Pharmaceutical Affairs Act on July 20th, but a grace period on its immediate implementation was granted until January 20th.

Therefore,
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