UNILATERAL APPROVAL
PINSTECH Type B(U) Package – PRTP-001
In 2012, PAEC submitted its intention to PNRA for the design and manufacturing of Type B(U) package to be used for transportation of radiopharmaceuticals. The Safety Analysis Report (SAR) and Quality Assurance Program (QAP) has been approved and manufacturing & testing of prototype package has also been completed. Upon verifying compliance with all applicable regulatory requirements, design approval certificate for PINSTECH Type B(U) package was awarded in Jan 2016 for five years. In 2020, PAEC applied for revalidation of the design approval certification. The application was thoroughly reviewed at PNRA and finally revalidation was awarded till Dec 2025.