Management of change in your business should be a main cornerstone of any robust and functioning Quality Management System (QMS). The main advantages of having a strong change control process within your business include:
Self-Inspections are an important part of GDP and ensuring you keep your activities and licence compliant.
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 are becoming increasingly more common as healthcare management tools used in hospitals and community settings.
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:
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.
