MIA for (IMP) Clinical Trials

QP Release for IMP Clinical Trials

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 access to 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.

QP SERVICE SUPPORTS

Supporting QP Services & Quality of your products in the marketplace.

MIAS APPROACH

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 to the MIAs MIA is sent to the HPRA (Irish Regulatory Body) for approval. This approval process can take as little as 7 days. On approval QP Batch Certification 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.

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 country.

  • Analytical retesting of imported finished product into the EU/EEA.

  • Repackaging or relabelling of medicinal products before distribution in the EU/EEA.

Benefits of using MIAS

Time to market: 2-4 month lead time v typical 9-12 month lead time to develop a PQS and obtain authorisation.
Cost savings: Outsourcing EU quality function (including QP activity) v employing EU Quality team.
Insights and Expertise: Our CEO is a former senior inspector with the Irish Competent Authority (HPRA) and is considered a Thought Leader in the area of EU GMP and GDP compliance.
Measured growth: Ability to scale up your European operations following proof of concept.

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