News about GMP/cGMP


Mutual recognition of inspections under the EU-UK Trade Agreement

Mutual recognition of inspections under the EU-UK Trade Agreement

Questions about the EU-UK Trade and Cooperation Agreement, which will apply from January 1, 2021, were clarified by the European Commission in a 39-page Q&A on the EU-UK Trade and Cooperation Agreement on December 24, 2020. In total, it consists of 133 pairs of questions and answers.

To avoid supply delays and duplicate inspections, the EU and UK also mutually recognize inspections and GMP certificates. Recognition applies to manufacturers located within the territory of the issuing authority. Under certain conditions, a party may extend recognition to manufacturers outside the territory. 

The 1449-page trade and cooperation agreement covers the following areas:  

  • Trade in goods and services 
  • Digital trade 
  • Intellectual property 
  • Public procurement 
  • Aviation and road transport 
  • Energy 
  • Fisheries  
  • Social security coordination 
  • Law enforcement and judicial cooperation in criminal matters 
  • Thematic cooperation and participation in Union programs  

The detailed provisions on pharmaceuticals are found in Annex TBT-2, which comprises 12 articles and three annexes.   


EUR-Lex: Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community of the one Part, and the United Kingdom of Great Britain and Northern Ireland, of the other Part

EC: Questions & Answers: EU-UK Trade and Cooperation Agreement