The United Kingdom (UK) submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union (EU). This means that the United Kingdom will become a ‘third country’ from 30 March 2019. According to Directive 2001/83/EC the reference member state (RMS) must be a member of the EU.
As a result the RMS role in Mutual Recognition and Decentralised Procedures (MRP/DCP) must be transferred to an EU country. The State Medicines Control Agency (VVKT), the competent authority of Lithuania, intends to take the RMS role from UK for 70 MRP/DCPs.
Some advantages of transferring the Reference Member State role to Lithuania include: State fees are significantly lower in Lithuania compared with most other EU countries – therefore MA maintenance costs would decrease; there are no licence maintenance fees; the VVKT’s communications are in perfect English; the agency is well represented in EU committees and is sensitive to timelines; the national phase of DCP/MRP procedures are predictable and one of the shortest in Europe.
Biomapas has its headquarters in Lithuania. As a contract research organization (CRO) it can provide both the initial regulatory support for an RMS switch and the long-term communication with the Health Authority. Initial activities would include switching the name of the marketing authorization holder and batch release site, and implementation of changes to product packaging.
Biomapas provides comprehensive clinical trial services for Phase I-IV clinical research and medical devices. This includes highly developed regulatory and pharmacovigilance teams. The company also has offices in Switzerland, Sweden, Georgia, Ukraine and Russia and has personnel in place to cover 60+ countries.