Regulation for Drug Shortage Management Article 3

Upon receiving the report mentioned in the preceding Article or learning about a possible shortage in the supply of essential drugs, the Central Competent Health Authority should conduct an assessment after the information is published on public websites. If necessary, it may request pharmaceutical firms that hold licenses for the drugs in question to explain and provide information.If the results of the preceding assessment indicate the possibility of a shortage in supply for certain essential drugs, the Central Competent Health Authority may publicly solicit pharmaceutical firms’ applications for special case approval.According to the results of the assessment referred to in Paragraph 1, if other pharmaceutical firms have such drug or a suitable substitute drug is available to make up for the shortage in supply, the preceding provisions shall not be applicable.