Pharmaceutical Good Manufacturing Practice Regulations Article 143
Manufacturers shall determine suitable expiration dates for medical devices for use in clinical trials based on the product properties, container characteristics and storage conditions; the expiration dates marked on aforesaid devices may not exceed the expiration dates marked on the original product packaging.
中文原文 藥物優良製造準則第143條
製造業者對於臨床試驗用醫療器材，應依產品性質、容器特性及儲存條件，決定標籤上適當之保存期限；其標示之有效期間，不得超過原包裝產品原標示之有效期間。