Supply Chain Oversight: Product Pathway
Activities requiring an MIA:
Batch disposition by a QP: A QP is named on the
Manufacturer's and Importer's Authorisation (MIA) and is responsible for the release of IMP to a clinical trial.
Importation of medicinal products into the
EU/EEA (including Biological API or Bulk Drug Product) from a 3rd
Analytical retesting of imported finished
product into the EU/EEA.
Repackaging or relabeling of medicinal products
before distribution in the EU/EEA.
GMP/ GDP Oversight:
Audits and Oversight:
Benefits for you: