Alert System. 1. Each Party shall maintain an Alert System that permits authorities of the other Party, when relevant, to be made aware proactively and with the appropriate speed in case of quality defect, recalls, falsified products, or potential serious shortages and other problems concerning quality or non-compliance with GMPs, which could necessitate additional controls or suspension of the distribution of the affected products. 2. Each Party undertakes to ensure that any market surveillance related to imported Pharmaceutical Products of the other Party shall be conducted in accordance with relevant reference country pharmacopoeias or validated test protocols as applicable to the manufacturer of such products.
Appears in 3 contracts
Sources: Technical Barriers to Trade Agreement, Comprehensive Economic Partnership Agreement, Comprehensive Economic Partnership Agreement