Alert System. Contact points shall be agreed between both Parties to permit authorities and manufacturers to inform the authorities of the other Party with the appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the batch. A detailed alert procedure shall be agreed. The Parties shall ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with GMP and which could have public health implications, are communicated to each other with the appropriate degree of urgency.
Alert System. 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, counterfeit or falsified products, or potential serious shortages and other problems concerning quality or non-compliance with GMP, which could necessitate additional controls or suspension of the distribution of the affected products.
Alert System. The details of an alert system will be developed during the transitional period. The system will be maintained in place at all times. Elements to be c onsidered in developing such a system are described in Appendix 5. Contact points will be agreed between both Parties to permit authorities to be made aware with the appropriate speed in c ase of quality defect, rec alls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the product.
Alert System. The Parties will put into place a two-way alert system between their Regulatory Authorities in order to inform each other of products that have been found not to comply with applicable technical regulations or can pose an imminent danger to health, safety or the environment. CHAPTER 6 ADDITIONAL PROVISIONS
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.
Alert System. 5.9.1 Contact points shall be agreed between the Parties to permit Regulatory Authorities and manufacturers of one Party to inform the Regulatory Authorities of the other Party with appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the batch. A detailed alert procedure shall be agreed.
5.9.2 The Parties shall ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with mandatory GMP requirements and which could affect the protection of public health, is communicated to each other with the appropriate degree of urgency.
Alert System. Franchisee shall install and thereafter maintain on the Cable Television System an emergency alert system as prescribed by the FCC and the 1992 Cable Act, as amended.
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 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- compliance with GMP that could necessitate additional controls or suspension of the distribution of the affected products.
Alert System. Conta ct points will be agreed between the Parties to permit c ompetent authorities and manufa cturers to inform the authorities of the other Party with the appropriate speed in c ase of quality defect, batch rec alls, c ounterfeiting and other problems c onc erning quality, which c ould nec essit ate a d ditional c ontrols or suspension of the distribution of the batch. A d etaile d alert proc edure will be agreed. The Parties shall ensure that any suspension or withdrawal (total or partial) of a manufa cturing authorization, based on non-c omplian c e with GMP and which c ould affect the prote ction of public health, are c ommunic ated to ea ch other with the appropriate degree of urgency.
Alert System. 1. The Joint Sectoral Group shall ensure that an efficient and effective "two-way" alert system is in place at all times. The contact points for each Party’s alert system will be specified in the Joint Sectoral Group’s Maintenance Program.
2. The Regulatory Authority of one Party shall inform the Regulatory Authority of the other Party with appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the batch.
3. The Parties shall ensure that any suspension or withdrawal (total or partial) of a Manufacturing Authorisation, based on non-compliance with Mandatory GMP Requirements and which could affect the protection of public health, is communicated to each other with the appropriate degree of urgency.
