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.
Good Distribution Practice (GDP): 3 Considerations for Ensuring Compliance
Ensuring product quality and integrity is maintained throughout the end-to-end supply chain of medicinal products is imperative. The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities...
HiTech Health presented at the 3rd Global Bioprocessing, Bioanalytical, and ATMP Manufacturing Congress in Dublin, Ireland
HiTech Health are delighted to have attended the 3rd Global Bioprocessing, Bioanalytics and ATMP Manufacturing Congress on 16th and 17th May. HiTech Health’s Quality and Compliance Lead Julie-Anne O'Neill and Manager of Cell and Gene Therapy Operations Aoife Duffy...
Understanding the New EU Clinical Trial Regulation (CTR)
On the 31st January 2022, The Clinical Trials Regulation ((Regulation (EU) No 536/2014)) became effective and replaced the previous Directive (EC) 2001/20/EC and corresponding national legislation. The Clinical Trials Regulation (CTR) coordinates the review and...
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