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.
Medical Device Apps – Stand-alone software and apps
Medical device apps are becoming increasingly more common as healthcare management tools used in hospitals and community settings.
Import Licensed Human Medicine(s) to the United Kingdom (UK) – Guidance
Import Licensed Human Medicine – Prior to importation of a licensed medicine applications for the relevant Licence(s) must be completed and submitted which may include one or more of the following:
Import Unlicensed Human Medicine(s) to the United Kingdom (UK) – guidance
An Introduced Product is an unlicensed medicine which can be imported from a country other than an approved country for import to be exported to a country other than an approved country for import, or if imported from a non-EEA country into Northern Ireland for export back to a country outside the EEA.
Termination of Licence, Authorisation or Registration
For the distribution of medicines and healthcare products, a licence, authorisation or registration is required depending on the type of activity.
