EU QP Responsibilities for Oversight of Product Quality:
Our team of QP's provide QP oversight of our clients' supply chain as per Annex 16 requirements.
Activities requiring an MIA for commercial product:
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 commercial
product to the market.
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.
Benefits for you: