MHRA Guidance Note 6
MHRA Guidance Note 6 – Notes for applicants and holders of a Wholesale Dealer’s Licence (WDA(H)) or Broker Registration was updated in November 2022 with some significant changes regarding Brexit.
The value of proper Export training – be prepared!
Many clients contact us for information and help on expanding the scope of their WDA license to include the ability to export UK licensed medicinal products without necessarily understanding the challenges of exporting UK licensed medicinal products.
Separation of the Licence Holder and Responsible Person
Separation of the Licence Holder and Responsible Person – The last paragraph on page 128 of the 2017 Green Guide contained the following sentence:
In the case of small companies, the licensing authority may accept the licence holder as the nominated RP.
Medical Devices – Consultation on the future regulation of medical devices in the United Kingdom
Following the UK’s exit from the European Union (EU), the government identified a unique opportunity to improve how medical devices and in vitro diagnostic medical devices (IVDs) are regulated in the United Kingdom.
Compliance Monitoring Process the MHRA’s new role
Compliance Monitoring Process – from April this year the MHRA are piloting a different approach to the monitoring of companies that are referred to the MHRA’s IAG (Inspection Action Group) for failure to comply with the standards of Good Manufacturing Practice or Good Distribution Practice.