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Brexit: MRA will be needed soon

04/03/2020

Three European Industry Associations (EFPIA, Medicines for Europe and AESGP) have published a "Call for a Mutual Recognition Agreement on Good Manufacturing Practice (GMP) in the Context of Ambitious and Comprehensive EU-UK Future Relationship Negotiations". In this paper, the associations state that "EU and UK should have the closest possible relationship for pharmaceuticals, prioritising the health of citizens and the uninterrupted supply of medicines."

They propose a pragmatic approach and hope that there "is openness at the earliest opportunity". It would be beneficial for all parties involved to come to Free Trade Agreement (FTA) as quick as possible. Such an agreement should cover:

  • Regulatory alignment and cooperation on human medicinal products,
  • Sharing of data,
  • Protection of intellectual property (IP),
  • Customs facilitation,
  • Rules of origin (RoO).

As an example, the EU-South Korea Free Trade Agreement is named.

However immediate action is seen in completing a Mutual Recognition Agreement (MRA) on Good Manufacturing Practice (GMP). Such an agreement should cover:

  • Waiving batch and import testing by manufacturers and OMCLs (official medicines control laboratories),
  • Recognition of GMP inspections between the EU and UK (including inspections in third countries),
  • Co-operation between regulators to focus on high-risk sites in need of inspection, including in third countries.


 

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