Pharmaceutical Affairs Act Article 45
The central competent health authority may set a specific period for monitoring the safety of the medicaments approved for manufacture or import.The central competent health authority shall establish matters that the pharmaceutical firms shall adhere to during the safety monitoring period referred to in the preceding paragraph.
中文原文 藥事法第45條
經核准製造或輸入之藥物，中央衛生主管機關得指定期間，監視其安全性。
藥商於前項安全監視期間應遵行事項，由中央衛生主管機關定之。
藥商於前項安全監視期間應遵行事項，由中央衛生主管機關定之。