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.
Appears in 5 contracts
Samples: Agreement, data.consilium.europa.eu, www.seco.admin.ch
Alert System. Contact points shall will be agreed between both the Parties to permit authorities Competent Authorities and manufacturers to inform the authorities 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 will be agreed. The Parties shall will ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-non compliance with GMP and which could have affect the protection of public health implicationshealth, are communicated to each other with the appropriate degree of urgency.
Appears in 3 contracts
Samples: eeas.europa.eu, ec.europa.eu, academy.gmp-compliance.org
Alert System. Contact points shall will be agreed between both the Parties to permit competent 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 will be agreed. The Parties shall will ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with GMP and which could have affect the protection of public health implicationshealth, are communicated to each other with the appropriate degree of urgency.
Appears in 2 contracts
Alert System. Contact points shall will be agreed between both the Parties to permit competent 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-non compliance with GMP and which could have affect the protection of public health implicationshealth, are communicated to each other with the appropriate degree of urgency.
Appears in 2 contracts
Samples: Agreement, ec.europa.eu
Alert System. Contact points shall will be agreed between both the Parties to permit competent 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 will 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 affect the protection of public health implicationshealth, are is communicated to each other with the appropriate degree of urgency.
Appears in 2 contracts