MIAS Pharma Limited is authorised to certify Investigational Medicinal Products (IMP) to sponsors of clinical trials in Europe and to support product importation into the EU. To comply with European regulatory requirements, to import IMPs you will need a Manufacturer’s/ Importation Authorisation (MIA). This is a licence granted by European Competent Authorities.
The MIAS Pharma MIA for IMPs (Clinical trials) allows us to partner with you to provide EU Qualified Person (QP) and Manufacturer/Importer Authorisation (MIA) services for the importation and certification of your Investigational Medicinal Product in the EU / EEA.
Use of the MIAS Pharma MIA for IMP
In order to add a product to the MIAS Pharma MIA all of the client’s contracted parties are reviewed against EU cGMP (current Good Manufacturing Practice) and cGDP (current Good Distribution Practice) as appropriate, to determine what variations are required to the MIAS Pharma MIA.
Once the MIAS Pharma QP is satisfied that the client supply chain meets EU GMP requirements, a variation is sent to the HPRA (Irish Regulatory Body) for approval. This approval process can take as little as 7 days. On approval QP Batch release can occur in line with our client’s requirements. Ensuring appropriate Quality standards is not only about batch release. The multiple parties in the supply chain need to meet EU GMP and GDP standards and to comply with the Marketing Authorisation. As an added value solution MIAS can put a dedicated resource in place to oversee the quality of our clients supply chain and to deal with any day-to-day quality-related issues arising.
On request MIAS Pharma can also provide end to end solutions to streamline your clinical trial through our extended partner network. Our extended services include:
- Market Access Strategy
- Legal & Financial Structure Advice
- Packaging & Labeling
- Reg Affairs (Pre-Approval / Post-Approval)
- Audit Program Support
- QA & RP Placements