Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak

GDP to meet supply needs.The following list of temporary regulatory flexibilities that will be allowed address the current exceptional circumstances.

The challenges arising from to COVID-19 are likely to change. As more information becomes available we may periodically review previous decisions to ensure they are still valid.They are being regularly reviewed and may be updated at any time.Responsible Persons may act as RP for another company within the same group of companies without variation, provided they have an RP registration number issued by MHRAStorage and distribution equipment may be used with limited qualification and validation to allow equipment to be used as soon as possible.

This should be supported by a risk assessment and additional mitigating measures where necessary. Remaining qualification and validation work should be completed retrospectively, with delay minimised as much as possibleSmall changes in various elements of the quality system will be permitted to provide more RP resource and enable focus on supplyFlexibilities relating to verification of unique identifier codes required by the Falsified Medicines Directive remain under consideration and our position on this will be communicated later.We recognise that the care of patients is your first priority.