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).
Unlicensed Medicines (Specials) can only be supplied under one of the following circumstances:
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.
UK licensed medicinal products and the challenges of exporting – Many clients contact us for information and help on expanding the scope of their WDA license to include the export UK licensed medicinal products without necessarily understanding the challenges of exporting UK licensed medicinal products.
