副作用・安全性情報の記載
韓国 ／ 食品医薬品安全処
副作用のある医薬品については、その副作用を否定する表現または不当に安全性を強調する表現による広告をしてはならず、医薬品等が誤用・乱用されないよう食品医薬品安全処長が定める事項を表示しなければならず、効能・効果に関連する病気の症状や手術場面を威嚇的に表示する広告、および適応症状を威嚇的な表現で表示・暗示する広告をしてはならない。
For a drug that has adverse reactions, no advertisement may use expressions that deny those adverse reactions or that unduly emphasise safety; matters prescribed by the Commissioner of the Ministry of Food and Drug Safety must be displayed so that the drug is not misused or abused; and advertisements may not display the symptoms of a disease related to the efficacy, or scenes of surgery, in a threatening manner, nor display or suggest the indication in threatening terms.
注記
BLOCKER RESOLVED; same retrieval route and currency check as the 'compare' entry. Operative Korean: 1.가 '의약품등이 오ㆍ남용되지 않도록 식품의약품안전처장이 정하는 사항을 표시할 것'; 2.차 '부작용이 있는 의약품에 대해서는 그 부작용을 부정하는 표현 또는 부당하게 안전성을 강조하는 표현의 광고를 하지 말 것'; 2.다 '효능이나 성능을 광고할 때에 사용 전후의 비교 등으로 그 사용결과를 표시 또는 암시하거나 적응증상을 위협적인 표현으로 표시 또는 암시하는 광고를 하지 말 것'; 2.거 '의약품의 효능ㆍ효과와 관련되는 병의 증상이나 수술장면을 위협적으로 표시하는 광고를 하지 말 것'. IMPORTANT LIMIT: Annex 7 frames the requirement as a prohibition (do not deny the adverse reactions, do not unduly emphasise safety) and delegates the positive display requirements to matters prescribed by the MFDS Commissioner under item 1.가; I did NOT open that MFDS notification, so Annex 7 does not by itself establish a general obligation to list adverse reactions, contraindications or precautions in the body of a Korean drug advertisement, and no such obligation should be inferred from this entry. Other items in the same annex bear on safe use: 2.아 bars advertising liable to cause misuse or abuse, 2.카 bars limiting the advertising audience to a particular group unrelated to the efficacy in a way liable to cause misuse or abuse by that group, 2.하 bars advertising paediatric drugs through children's broadcast programmes or children's magazines and other printed matter, and 2.너 bars advertising the efficacy of an ingredient that is not a main ingredient.
BLOCKER RESOLVED; same retrieval route and currency check as the 'compare' entry. Operative Korean: 1.가 '의약품등이 오ㆍ남용되지 않도록 식품의약품안전처장이 정하는 사항을 표시할 것'; 2.차 '부작용이 있는 의약품에 대해서는 그 부작용을 부정하는 표현 또는 부당하게 안전성을 강조하는 표현의 광고를 하지 말 것'; 2.다 '효능이나 성능을 광고할 때에 사용 전후의 비교 등으로 그 사용결과를 표시 또는 암시하거나 적응증상을 위협적인 표현으로 표시 또는 암시하는 광고를 하지 말 것'; 2.거 '의약품의 효능ㆍ효과와 관련되는 병의 증상이나 수술장면을 위협적으로 표시하는 광고를 하지 말 것'. IMPORTANT LIMIT: Annex 7 frames the requirement as a prohibition (do not deny the adverse reactions, do not unduly emphasise safety) and delegates the positive display requirements to matters prescribed by the MFDS Commissioner under item 1.가; I did NOT open that MFDS notification, so Annex 7 does not by itself establish a general obligation to list adverse reactions, contraindications or precautions in the body of a Korean drug advertisement, and no such obligation should be inferred from this entry. Other items in the same annex bear on safe use: 2.아 bars advertising liable to cause misuse or abuse, 2.카 bars limiting the advertising audience to a particular group unrelated to the efficacy in a way liable to cause misuse or abuse by that group, 2.하 bars advertising paediatric drugs through children's broadcast programmes or children's magazines and other printed matter, and 2.너 bars advertising the efficacy of an ingredient that is not a main ingredient.