BREXIT – are your company prepared?

Due to BREXIT, the United Kingdom (UK) will probably leave EEA. Consequently, the EU rules in the field of medicinal products will no longer apply to the UK, subject to any transitional agreement that may be contained in a possible withdrawal agreement. This means that the UK may have the same status as any other third country.

EU law requires that:
Marketing authorisation holders are established in the EEA. Key activities and personnel are based or performed in the EEA.

This will affect companies with key activities and personnel based in the UK. Companies that have not relocated such resources within the EEA, prior to the Brexit, may suffer consequences related to the import/export of medicinal products between the EEA and the UK.

A major challenge for the pharmaceutical industry will be to minimise supply disruptions and avoid shortages of human and veterinary medicines caused by lack of custom and trade agreements between the UK and the EEA.

Norway is part of the EEA. Mericon may therefore assist companies in such situations and can provide key personnel within Pharmacovigilance, Good Distribution Practice, and Good Manufacturing Practice:

Pharmacovigilance; Highly qualified QPPV and/or deputy QPPV. A QPPV and deputy QPPV resided in Norway, may also carry out his/her tasks in UK. This includes competence within:

EudraVigilance (EV)
Pharmacovigilance System Master file (PSMF)/Detailed Description of the PV System (DDPS)
Case handling
Local literature search and review
Risk Management Plan (RMP)
Pharmacovigilance training
PV audits
Quality systems and standard operative procedures (SOPs)
Preparation and submission of safety variations
Medical Information Office/Scientific Service

Good Distribution Practice; Highly qualified RP/FFA and/or deputy RP/FFA, and the following processes;

GDP procedures services
GDP audit services
GDP training

Good Manufacturing Practice; Highly qualified QP, and the following processes;

GMP procedures services
GMP audit services
GMP training