For all companies wishing to import and/or release batches of medicines in the EU , it is a legal requirement to hold a commercial MIA licence granted by a European country’s national regulatory authority. A commercial MIA licence is also required for repackaging or relabelling of medicinal products as well as any analytical retesting of imported finished product. HiTech Health are now in an excellent position to offer clients the opportunity to avail of our commercial MIA licence to certify medicinal products for release to the EU market. This offers the benefit of companies not having to substantially invest in the costly and thorough process of obtaining their own MIA licence which involves implementing a full quality management system (QMS). By partnering with HiTech Health, companies could potentially benefit from the three main advantages below:
- Experienced cross-functional team to support clients every step of the way. HiTech Health employees have over 100 years of combined industry experience in Quality, Operations and Supply Chain and have a proven track record of delivering results for clients.
- Financial savings: Instead of setting up an office and hiring a team of full-time employees in the EU, it is financially more cost effective to contract HiTech Health to provide the required quality services with no obligations for long-term commitments.
- Timeline reduction: Developing a QMS and starting the MIA application process could take up to 12 months. Collaborating with HiTech Health can accelerate this lead-time to 3-4 months and help patients in a quicker time frame. After Brexit, Ireland is the only English-speaking country in the European Union.
Clinical Trials MIA (IMPs)
In addition to commercial drug batches, HiTech Health is now authorised to import and certify Investigational Medicinal Products (IMPs) for use in clinical trials within the EU. We can support the release and supply of IMPs to clinical trial sponsor sites throughout the EU in a cost effective and timely manner. After confirming a product has been manufactured and tested in accordance with EU GMP requirements, the HiTech Health MIA licence enables us to import and certify IMPs on behalf of clients allowing them to focus on their other core business activities. Our experienced in-house team have extensive knowledge of clinical trial sponsors and centres across Europe and can assist with supporting products to commercialisation.
EU Qualified Person (QP) Services in Cell & Gene Therapy (CGT)
In Europe, no batch of medicinal product can be released prior to certification by a Qualified Person (QP). Due to the rapidly evolving Advanced Therapeutic Medicinal Products (ATMP) landscape, it’s important to have up-to-date knowledge, expertise as well as years of...
HiTech Health Attending Phacilitate’s Advanced Therapies Week 2023 in Miami, USA
Hitech Health's Cell and Gene Therapy Operations Manager Aoife Duffy and Global Head of Commercial Clare O’Sullivan will be attending Phacilitate's Advanced Therapies Week 2023 in Miami from January 17th – 20th. Advanced Therapies Week is the destination for...
Hitech Health Appoint Clare O’Sullivan as Global Head of Commercial
Hitech Health is delighted to announce the appointment of Clare O’Sullivan as Global Head of Commercial. Brian Harrison, Managing Director of HiTech Health, commented on Clare’s appointment: “I am pleased to announce the appointment of Clare O’Sullivan as Global Head...
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