KR Südkorea
  • 11 - Medizintechnik

Pharmaceutics (ICS 11.120)

Regulation on Safety of Pharmaceuticals, etc. (63 pages, available in Korean) (63 page(s), in Korean)

From Article 56-3 to 56-7: Develop a concrete procedure regarding the registration and inspection of foreign manufacturing site of imported pharmaceuticals, etc.

The following regulation is newly established; where an obligation of registering a foreign manufacturing site is imposed on an importer and measures on the safety of pharmaceuticals are deemed necessary according to the revision of Pharmaceutical Affairs Act, the Minister of Ministry of Food and Drug Safety may ask to suspend the import and order the inspection of quality, etc. and request the correction with the onsite inspection. The purpose of this new regulation is to secure the integrity of the law by regulating mandated matters by the Ordinance of the Prime Minister in Pharmaceutical Affairs Act including a procedure of registering a foreign manufacturing site, a subject to register and notify of changes, a procedure and method of onsite inspection, measures on suspension of import, etc. and any related matter of dissolution, etc.