Regulation for Drug Shortage Management Article 9

If the drugs are approved to be manufactured or imported as special cases, their approval term is up to one year. Extension can be applied for 30 days before expiration. The extension period lasts six months each time, and the applicant can only apply for an extension twice. However, this restriction does not apply to applicants acknowledged by the Central Competent Health Authority.Application for the above extension can be submitted to the Central Competent Health Authority in accordance with Articles 5 and 6. If the essential drugs or their substitute drugs do not face shortage in supply, the extension applications may be rejected.