Brexit Transition Services

Flow-Chart-Mobile-hr

Brexit Transition Services

As a result of the UK referendum, the UK will cease to be a member of the EU on the 30th March 2019. This will have a considerable impact on EU medicines approval since the UK MHRA acts as rapporteur for around 15% of Centralised applications and contributes approximately 30% of the EU experts available for EMA Committees.

In addition to this wider environmental impact, there will be specific implications for individual product licences. Initially both the EMA and MHRA advised that it was ‘business as usual’ until notified, but the publication of the EU Commission and EMA Notice to Marketing Authorisation Holders and Questions and Answers related to the United Kingdom’s withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure, changed that situation.

At NDA we’ve created a suite of services to help manage the transition of individual products as well as portfolios through the Brexit, taking into account any procedural, legal and organizational impacts that this may have on the sponsor.

Through a Strategic Product Impact Review NDA’s dedicated team assesses the impact to your portfolio or individual product from multiple business critical perspectives. Through NDA’s established practices, agreed changes can then further be supported operationally covering critical activities such as:

  • Transfer of MAH registrations and responsibilities
  • Management of ODD and SME status
  • Manufacture transfer and license applications
  • Packaging updates
  • Interim safety governance and QPPV transfer
  • Vendor evaluation and activity transfer

 

Regulatory Accountability

A number of accountabilities held with UK affiliates or headquarters will need to move to legal entities based in the EU. Following Brexit, the UK will become a ‘third country’ so any EU Centralised licences which name a UK entity as the Marketing Authorisation Holder (MAH) must be varied to transfer the licence to an EU company. The same applies to Orphan Drug Designations (ODDs) and registered SME status.

• Is your product held by a MAH in the UK?

• Is your ODD or your SME status registered with a UK company?

If the answer is yes to any of these questions NDA can help you transition in a predictable and effective manner.

Manufacturing, release and packaging

UK manufacturing sites for finished products will not be able to release batches of product onto the EU market after Brexit. Following Brexit, active substances manufactured at UK plants will also be considered imported active substances and will require certification from the MHRA that the plant manufacturing the active substance is complying with an equivalent to EU GMP.

Any documents which reference details of the MAH and manufacturers will also need to be updated including the product information and pack. The variations will need to be carefully planned to minimise packed stock wastage.

• Are you or any part of your supply chain manufacturing in the UK?

• Are you providing products with packaging mentioning the UK?

• Are you worried about disruptions to stock or sales due to the need for regulatory variations?

If the answer is yes to any of these questions NDA can help you transition in a predictable and effective manner.

Safety Governance and QPPV

The EC Directives prescribe that a Qualified Person for Pharmacovigilance (QPPV) must reside within an EU Member State. A named QPPV that resides within EU/EEA must therefore be identified for each EU license, if the current QPPV is based in the UK. Similarly the PV system must be managed and the Pharmacovigilance System Master File must reside within an EU country.

• Are you dependent on EU safety monitoring from the UK?

• Is your QPPV based in the UK?

• Are you concerned there may be risks to patients involved in managing your Brexit activities?

If the answer is yes to any of these questions NDA can help you transition in a predictable and effective manner.

Organisation and vendors

All changes and transition activities associated with Brexit will have different impact on the organisations and vendors used by affected companies. In some cases UK based vendors will no longer be an option to support many of the activities previously performed out of the UK.

In addition to assessing the organisational and vendor impact, NDA’s consultants have extensive experience with managing large numbers of regulatory variations and supporting operational changes for production, including supply chain, highly effectively.

• Are you concerned about the high volume of activities that will impact your organisation due to Brexit?

• Are you concerned that you may not be able to rely on existing vendors for all of the activities that have been performed in the past?

• Are you looking to move legal responsibilities across sites or setup new affiliates?

If the answer is yes to any of these questions NDA can help you transition in a predictable and effective manner.