COVID-19: Temporary Regulatory Flexibilities for Wholesalers in the UK

Recommendation

Thursday, 1 October 2020 14.00 - 15.30 h

Webinar GDP for APIs

The current exceptional circumstances during the COVID-19 outbreak have given rise to difficulties for wholesalers applying the safeguards in GDP to meet supply needs.

Now, the Medicines and Healthcare products Regulatory Agency (MHRA) has published a Guidance on "exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak". The guidance contains a  list of temporary regulatory flexibilities that will be allowed to address the current exceptional circumstances. 

The following areas are covered:

• Supply chain
• Transportation 
• Responsible Persons (RP)
• Facilities and equipment

For example, "non-temperature-controlled transport may be used when the ambient temperature is less than 20 °C". Furthermore, Responsible Persons (RP) "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." Concerning 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."

Wholesalers who want to use the flexibilities should record the decision with a brief explanation of why this was necessary. To make use of the regulatory flexibilities does not require prior approval but must, however, be reported to MHRA.

The list of temporary regulatory flexibilities is reviewed by the MHRA on a regular base and may be updated at any time.