KR Südkorea
  • 30 - Pharmazeutische Erzeugnisse


Enforcement Decree Of The Pharmaceutical Affairs Act; (11 page(s), in Korean)

As the Pharmaceutical Affairs Act was revised adding the phrase 'The Minister of the Ministry of Food and Drug Safety may announce the description of the violation which was confirmed with the administrative measure due to the violation of the Act' (Act No. 18970, Notification Date June 10, 2022, Enforcement Date December 11, 2022), to establish a legal basis of determination of conformity on GMP and access and inspection for the manufacturer by the GMP inspector. In addition, to prescribe what is mandated by the Act including content of the documents and content method of the public Announcement of the respecting the description of violation and what is necessary to implement the mandates in the Act, if a GMP inspector intends to access the manufacturer and carry out the inspection on the facility.