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.
For the distribution of medicines and healthcare products, a licence, authorisation or registration is required depending on the type of activity.
There is a new MHRA Green Guide Update 2022 updated edition of the Rules and Guidance for Pharmaceutical Distributors called the MHRA Green Guide.
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.
Mobocertinib has now been fast-tracked and will be made available to NHS England eligible lung cancer patients within weeks.
What makes a good RP? – The Responsible Person (RP) title is the named person on a Wholesale Distribution Authorisation (WDA).
