brexit

Let’s be Brexit Prepared

According to the EMA, the UK’s decision to leave the EU has a consequential impact on the biopharmaceutical and pharmaceutical industry. The challenge of Brexit for companies is the uncertainty of the future trading and regulatory relationship with the European Union.  This is compounded by a highly charged political situation within the EU and within the current UK Government.

It is widely accepted that the legislative changes and working arrangements between the UK and the EU are going to be difficult to define, let alone the complexity. Transition periods for the UK’s exit from the European Union are still subject to discussion and agreement.  But the advice from all quarters is that action is required as soon as possible on the assumption that a ‘hard Brexit’ will occur on the 30th of March 2019.

We also recognize the pressure this decision has on the regulators to keep the mechanism of medicines regulation moving.  The MHRA in the UK has been a linchpin in the European Union medicines review and approval system. If clients have significant commercial ties to EU customers, maintaining a direct presence in the European Union may be required which leaves companies in a difficult position in terms of planning and preparation.

How VCLS can assist you?

VCLS has developed a scheme in order to ensure a smooth service delivery for our different clients’ needs where they will benefit from our unparalleled wealth of expertise across all aspects of product development and commercialization activity from our experts in the following areas:

  • Preparing for the future – Scenario planning
  • Risk assessment of existing product development activity
  • Review of regulatory complexity that may impact on launch times
  • Review your development and risk management plans
  • Writing and/or amending your development plan
  • Assessing presence in the EU and impact on supply chain
  • Specific roles that may require relocation (e.g. Qualified Person, or QPPV)
  • UK market access and pricing determinants that may have international knock-on effects
Regulatory Science

Regulatory Science

  • SMEs /ODDs/MAHs must be transferred to EU
  • UK patients will not be taken into account for Prevalence calculations
  • Reference products must be in the EU – generic/hybrid MAs granted before 30th March 2019 remain valid (see also Biosimilar).
  • Local Representative (within the PI) must be in the EU (Article 61(3))
  • Sunset Clause – Will lapse from Brexit date (if only marketed  in the UK)
Supply chain

Supply chain

  • Batch (control) Release Site to be located in EU
  • Official Medicines Control Laboratory (OMCL) must be located in the EU
  • API and FP sites in UK will be required to meet  importation requirements, a specific importation site in the EU is required
  • GMP inspections carried out by MHRA (before 30th March 2019), remain valid
  • Multi Packs – Provisional use of the Blue Box
Clinical Trials

Clinical Trials

  • Legal Representative for CTs must be in EU
  • GCP inspections carried out by MHRA (before 30th March 2019), remain valid
  • Samples i.e. export / import requirements
Pharmacovigilance

Pharmacovigilance

  • QPPV/Deputy QPPV to be located in EU (changes can be made through article 57 database)
  • PSMF must be in the EU
  • PV inspections carried out by MHRA (before 30th March 2019), remain valid

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