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.
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Sources: Sectoral Annex I Medicinal Products, Mutual Recognition Agreement