Services

MIAS Pharma MIA services.



MIAS Pharma Limited holds two MIAs to cover medicinal products for human use in EU/EEA:

1. MIA for Investigational Medicinal Products (IMPs)
2. MIA for Commercial Products

These contract services enable you to import and batch release medicinal products in a compliant manner with no significant investment in licence application or maintenance activities or office/personnel costs.

 MIAS Pharma provides:

  • Qualified Person (QP) services. The Qualified Person is the person defined in Article 48 of the Directive 2001/83/EC and Article 53 of Directive 2001/82/EC as certifying release of medicinal products for shipment to market or for use in clinical trials. The primary legal responsibility of the Qualified Person is to certify batches of medicinal product prior to use. QP release is also required for medicinal products manufactured within the EU/EEA for export. In all cases, the Qualified Person is named on the relevant Manufacturer and Importer Authorisation (MIA). A manufacturer of finished medicinal products must have at their disposal the services of at least one Qualified Person.

MIAS Pharma provides oversight of:

  • Regulatory compliance of manufacturing activities
  • Regulatory compliance of Analytical Testing and Retesting through strategic partnership 
  • Regulatory compliance of Repackaging / Relabelling services through strategic partnership 
  • Regulatory compliance of Shipment and Transportation activities through strategic partnership 
     

MIAS Pharma your European Partner

Contact our team today to initiate your European Experience.

Email: info@miaspharma.com
Phone: 00 353 (01) 846 3605/4




If you are interested in exploring how we can help you, please get in touch to discuss how MIAS Pharma Limited can assist your organisation, contact us at +353 01 846 3605/4 or info@miaspharma.com.
MIAS Pharma International performs selection / qualification audits of all our strategic partners to confirm the standards meet GMP / GDP requirements. These audits are open to inspection by the HPRA.