MHRA new recognition routes to access to new medicines
After Brexit the MHRA had been preparing to take over the role of sole approver of newly licensed medicines in the UK until now.
MHRA inspection process
At the recent MHRA GDP Symposium held in February the inspectorate announced a change to the MHRA inspection process.
Update GMP and GDP Certificates
Anyone who has recently reviewed the Medicines and Healthcare products Regulatory Agency (MHRA) CMS may have noticed the notification at the bottom of the search page regarding GMP and GDP Certificates, stating the following
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.
Unlicensed Cannabis-Based Products for Medicinal (CBPM) Use
On the 16th of November 2022 the Medicines and Healthcare products Regulatory Agency (MHRA) released a blog with guidance on the process for approving Manufacturing Authorisations/ API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal (CBPM) use.
MHRA Response to contaminated paediatric medicines
On the 7th of October The Medicines and Healthcare products Regulatory Agency (MHRA) released a response to contaminated paediatric medicines identified by the WHO region of Africa.