The transition period that followed the UK’s withdrawal from the European Union (EU) came to an end on the 31st December 2020. As of the 1st January 2021, the UK is no longer part of the harmonised EU medicines network. Developers of medicinal products and medical devices should be aware of the impact that this change could have on the development and commercialisation of their assets.
For the UK, TMC is continuing to work on behalf of its clients to support new and ongoing UK and RoW clinical trials as well as working directly with the Medicines and Healthcare products Regulatory Agency (MHRA) on approvals for UK paediatric investigational plans (PIP), UK orphan drug designations (ODD) and UK marketing authorisation applications (MAA).
For the EU and RoW, TMC is perfectly positioned to provide seamless support to its clients based across the globe that are developing or commercialising medicinal products or medical devices in the UK, EU, USA etc. TMC Pharma (EU) Ltd, based in Waterford, Ireland, enables TMC to continue to provide its clients with services that require a presence in the EU, detailed below.
The Clinical Trials Directive 2001/20/EC states that for clinical trials
“…the sponsor or a legal representative of the sponsor must be established in the Community.”
Similarly, when the new Clinical Trial Regulation (EU) No 536/2014 comes into effect, sponsors of clinical trials will be required to have either a designated EU legal representative or EU-based contact person. TMC can offer either service through its Irish entity TMC Pharma (EU) Ltd.
The legislation on orphan medicinal products, Regulation (EC) 141/2000, states that the sponsor of an orphan drug designation (ODD) must be established within the European Economic Area (EEA).
TMC Pharma (EU) Ltd can act as sponsor of EU ODDs throughout a product’s development, up to the time of market authorisation and beyond, if required (see Acting as Marketing Authorisation Holder in the European Union).
The holders of EEA marketing authorisations granted under Directive 2001/83/EC or Regulation (EC) 726/2004 must be established within the EEA.
TMC Pharma (EU) Ltd can act as applicant and eventual holder of EEA marketing authorisations on behalf of its clients whilst alternative, more permanent arrangements are made.
As a qualified micro/small/medium enterprise (SME), TMC’s EU presence also allows its ex-EU clients access to the SME incentives on offer from the European Medicines Agency (EMA) such as fee reductions and exemptions, access to workshops and training sessions and assistance with translations.
Directive 2001/83/EC states that the EU QPPV (and their back-up) must reside and operate in the EU, except that, following EEA agreements, the QPPV may also reside and operate in Norway, Iceland or Liechtenstein.
TMC provides its clients with EU QPPV services through our Irish entity TMC Pharma (EU) Ltd.
In accordance with Directive 2001/83/EC, the Qualified Person (QP) of the manufacturing and importation authorisation holder is responsible to certify that each batch of medicinal product for the EU market has been manufactured in accordance with EU Good Manufacturing Practice (GMP) requirements and the marketing authorisation.
TMC works with sites of import and QPs in a number of EU countries and is able to provide QP batch release services in the EU through its Irish entity.