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Beyond Brexit: Diamond Secures EU Business Continuity

16 February 2018

Brexit

AUTHOR: Antony Appleyard



Diamond Pharma Services (DPS) announce the opening of EU Headquarters in The Netherlands to maintain continuity of services through the Brexit process. The opening of Diamond Pharma Services B.V. also adds to our existing EU office in Sofia , increasing our footprint in continental Europe.

One of the consequences of the vote by the UK to leave the EU has been a threat to UK based pharmaceutical industry and related service providers to maintain continuity of business in the EU after 29th March 2019. It has been stated repeatedly by the European Commission (EC), European Medicines Agency (EMA) and Heads of Medicines Agency (HMA) that for market authorisation holders to be sure that medicines can remain on the EU market they should be ready for the UK being a third country after 29th March (a Hard-Brexit scenario). Obviously, there is still much negotiation to be done and some hybrid position or sector-deal may be achieved. But this is not certain.

At Diamond Pharma Services we have committed to maintain and grow our EU presence in the fields of pharmaceutical regulatory affairs, pharmacovigilance, quality and compliance. Soon after the triggering of Article 50 we stated our business plan, and we explained how we would help our clients to navigate the uncertainties of Brexit, keep medicines on the market and identify strategic advantages (1&2). Specifically, we announced:

  1. A Brexit Package.
    This package of services includes the provision of a portfolio gap analysis for clients to identify risks and opportunities. Subsequently a suite of tasks has been assembled along with third party providers to assist in the maintenance of licenses in the EU and UK post-Brexit. These tasks cover regulatory, pharmacovigilance, drug supply, batch release, distribution, establishment of UK/EU legal entities and more.
  2. EU Entity
    In a Hard-Brexit scenario DPS would require a legal entity in the EU to hold Orphan designations, as well as Small and Medium Enterprise designations. We have now opened Diamond Pharma Services B.V. at Amsterdam Zuid, a metro stop away from the stated future location for the EMA. We will develop this facility as part of a growth plan for UK, EU and US services.
  3. EU located services
    As negotiations continue, DPS will consider the need for QPPV and QP services in the EU and we have advanced plans should this become a requirement after the departure of the UK from the EU.

We are delighted that progress has been made within our stated timelines for the development of Brexit-related services, and for the establishment of EU headquarters to supplement our UK based Global headquarters. For further details on our Brexit-position and our plans for continued growth please contact us at info@diamondpharmaservices.com