The continued growth in the development of cell and gene therapies (CGTs) has led to an exponential increase in the workload of the organisations involved. As ClinicalTrials.gov. indicates, there will be more than 1,000 ongoing clinical trials for CGTs registered in...
EU Market Access for UK Companies
EU Market Access for UK Companies
The UK life sciences industry contributes over £30 billion to the UK economy, and supports almost half a million UK jobs. The UK is a leading centre of medical research and biopharmaceutical innovation and is at the forefront of drug development and approval. With the Brexit transition period ending in less than six weeks, the UK pharmaceutical industry is increasingly focused on taking actions to ensure the continuity of supply of their products to patients during this transition, and to ensure their companies’ long-term access to markets and providing products to patients throughout Europe. This has been made all the made difficult by Covid-19 and its devastating impacts.
What we know so far is that, from 1st January 2021, the following will occur:
- Marketing Authorisation (MA) holders, if held in UK, will have to be transferred to an EU or EEA country.
- Each consignment of UK-manufactured Active Pharmaceutical Ingredients (APIs) to the EU/EEA needs to be accompanied by an MHRA certificate of conformation to EU GMPs.
- Each batch of UK-manufactured drug product intended for the EU/EEA market will need to be released by a QP within the EU/EEA.
- Pharmacovigilance of drug products placed on the EU/EEA market will need to be managed from a location within the EU/EEA.
- There will no longer be unrestricted transport of goods between the EU and the UK.
- Expect added paperwork, transport delays, and likely customs duties.
HiTech Health can act as an extension to your internal team within Europe. We offer Qualified Person (QP) services for the batch release and supply of medicinal products that can save you time and money when compared to building this expertise internally in Europe. With existing customers in the UK, we can provide a team to enable all the EU activities including product importation, QP certification and management of supply chain through to your distributor.
For the importation of medicinal products from the Great Britain (GB) to the EU, HiTech Health can act as the Importer of Record (IoR) for your company. Movement of goods from GB to the EU will be classified as international movements. Therefore, such movements will require transit declarations and tariffs. These tariffs will depend on the provision of a product identification code and HiTech Health can fully support you with this process.
The support we provide will be tailored to your company’s needs. Please email us at email@example.com to request further information on the range of services we can provide.
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