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  • MOHW proposes an alternative to law on generic substitution
  • by Lee, Jeong-Hwan | translator Alice Kang | Aug 19, 2025 06:11am
shifts stance to granting ¡°conditional approval¡±
Possibility of revision to the Pharmaceutical Affairs Act increases, but HIRA remains cautious
A revision to the Pharmaceutical Affairs Act that would allow pharmacies to report generic substitution to the Health Insurance Review and Assessment Service (HIRA) through its work portal is likely to pass the National Assembly.

The background to the sudden increase in the likelihood of legislation is that the Ministry of Health and Welfare submitted its own alternative proposal to the National Assembly regarding the bill to simplify generic substitution by pharmacies and changed its position to conditional approval (acceptance) on the premise that its alternative proposal would be adopted.

If the National Assembly accepts the alternative proposal submitted by the MOHW, the simplification of post-notification
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