Regulators in both established and maturing agencies are facing challenges in their effort to provide...
The Brexit negotiations have taken a dramatic turn this week, with the British Government rejecting the European Union’s (EU) proposals to be part of the European Economic Area (EEA) and have put forward counter-proposals that will ensure that UK can negotiate free trade arrangement with both the EU and other global markets.
The net effect on the UK Pharmaceutical industry will be that from 30 March 2019 the UK will no longer be part of the EU, and despite the transitional period to December 2020 the UK will be treated as a third country to the EU, and will be required to comply with EU regulations for product registration and importation of medicines similar to those regulations currently applied to trade between Switzerland and the EU.
Many large companies with EU/UK subsidiaries have already prepared contingency plans to assure their ability to continue to supply the markets, but the EU Commission has expressed concern that many marketing authorisation holders have still not yet started to prepared for Brexit.
While recognising the complexity of some of these procedures, they have observed that there still seems to be a number of companies adopting a wait-and-see approach
If your company has not yet planed a BREXIT strategy please contact PharmaConsult Global.
The company will not only establish legal entities for companies in either the EU or the UK, so that they can hold marketing authorisations (MA) for the products they need to market in EU or UK, but will also provide the means to:
- Obtain manufacturing/ importation approval and wholesale dealer’s licences to enable companies to import and to distribute products in the EU or UK
- Outsource ISO 17025 accredited analytical testing facilities for testing the imported commercial product
- Provide local qualified person (QP) certification for batch release for commercial and/or investigational medicinal products (IMP) to either the EU or UK markets or clinical research organisations (CRO)
- Outsource good manufacturing practice (GMP) / good distribution practice (GDP) compliant storage facilities for product awaiting distribution
- Provide local QP vigilance monitoring and reporting to EdraVigilance
Please contact PharmaConsult Global using the form on this page to discuss your Brexit contingency plan.
This white paper identifies some of the socio-economic factors that are influencing growth in the...
The UK Brexit secretary Dominic Raab has announced that even though the UK Government is...
At the European Council of Ministers meeting in Sofia, Bulgaria, UK Prime Minister Theresa May...