Common use of Alert System Clause in Contracts

Alert System. Each Authority shall maintain an alert system that permits the Authority of the other Party to be made aware, proactively and with the appropriate speed, of: (a) quality defects as outlined in the Pharmaceutical Inspection Convention/Scheme (PIC/S) Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Standard Operating Procedure dated 1 July 2017, as amended; (b) recalls as outlined in the PIC/S Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Standard Operating Procedure dated 1 July 2017, as amended; (c) counterfeit or falsified products as outlined in the PIC/S Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Standard Operating Procedure dated 1 July 2017, as amended; or (d) potential serious shortages and other problems concerning quality or non-compliance with GMP that could necessitate additional controls or suspension of the distribution of the affected products.

Alert System. Each Authority shall maintain an alert system that permits the Authority of the other Party to be made aware, proactively and with the appropriate speed, of: (a) quality defects as outlined in the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Standard Operating Procedure dated 1 July 2017, as amended; (b) recalls as outlined in the PIC/S Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Standard Operating Procedure dated 1 July 2017, as amended; (c) counterfeit or falsified products as outlined in the PIC/S Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Standard Operating Procedure dated 1 July 2017, as amended; or (d) potential serious shortages and other problems concerning quality or non-non- compliance with GMP that could necessitate additional controls or suspension of the distribution of the affected products.