Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak
Guidance for industry on flexible approaches we are taking on good distribution practices.
We understand that disruption to the supply chain has given rise to difficulties for wholesalers in applying the safeguards in 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.
Supply chain
- Periodic supplier and customer requalification may be deferred. Interim reliance may be placed upon regular review of our notifications of suspended wholesale dealer authorisations (WDA(H)) and any General Pharmaceutical Council registration updates
- Medicines may be returned to saleable stock if returned from the wholesale distribution chain within 10 days
Transportation
- Non-temperature-controlled transport may be used when the ambient temperature is less than 20°C
- ‘Do not refrigerate’ products should be identified and shipped appropriately when the ambient temperature is less than 8°C. A risk assessment should be in place for products transported under these conditions, with mitigating measures implemented where necessary
- Products may be held for up to 96 hours at a transit hub without a WDA(H) to assist in transportation. A risk assessment in respect of storage conditions and security should be in place, with mitigating measures implemented where necessary
- Alternative arrangements to show proof of delivery will be permitted
Responsible Persons (RP)
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 MHRA
Facilities and equipment
Storage 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 possible
Small changes in various elements of the quality system will be permitted to provide more RP resource and enable focus on supply
- Management of deviations – following assessment by the RP to determine the impact of a deviation or non-conformance, investigation of ‘minor’ events may be put on hold. These should be tracked, with investigations initiated in response to an identified trend
- Post inspection regulatory commitments relating to deficiencies classified as ‘Other’ may be put on hold. These should be recorded in the quality system and corrected after pandemic restrictions are lifted
- Routine Standard Operating Procedure reviews may be extended
- Electronic alternatives to wet signatures will be permitted. Distributors should ensure that interim ways of working are designed to accommodate data integrity principles
- Internal audit (self-inspection) and GDP refresher training may be put on hold. Training new personnel in GDP principles, and training of procedural updates should continue
Flexibilities 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. We will do everything we can to support you in the decisions you need to make. To do so we need you to ensure that when you make relevant decisions, you have carefully evaluated the risks and you are fully transparent.
Reporting your use of this guidance
Wholesalers using these flexibilities should record the decision using existing local procedures for recording unexpected events, with a brief explanation of why this was necessary.
It must also be reported to MHRA at [email protected].
These reports do not require prior approval to implement. Reporting decisions will assist regulators in monitoring the national situation in real time and take further actions to address common difficulties as situations change.
If these flexibilities do not provide enough scope to enable quick actions to the current logistical challenges, please report this to us as soon as it becomes apparent. Reporting any difficulties will assist us to monitor the national situation in real time and take actions to support critical supply chains while continuing to protect public health.