MHRA Green Guide Update 2022
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 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.
Mobocertinib – Eligible Lung Cancer patients in England to be offered innovative treatment
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?
What makes a good RP? – The Responsible Person (RP) title is the named person on a Wholesale Distribution Authorisation (WDA).
Confirming the Licensed Status of a Medicine
Unlicensed Medicines (Specials) can only be supplied under one of the following circumstances:
Advanced Therapy Medicinal Products (ATMPs)
Advanced Therapy Medicinal Products (ATMPs) are medicines based on genes, tissues or cells for human use. ATMPs offer an innovative perspective for the treatment of disease and injury.