European Commission outlines the impact of Brexit on Good Laboratory Practice

From 1st November 2019, it is likely that the United Kingdom (UK) will no longer be a member of the European Union (EU). The European Commission has outlined the consequences of how EU rules in the field of Good Laboratory Practice (GLP) will no longer apply to the UK after Brexit, however an EU-wide “Mutual Acceptance of Data” (MAD) system will apply.

Under the Organisation for Economic Co-operation and Development (OECD), the MAD system will apply as of the UK’s withdrawal date from the EU. The European Commission stated that all member states participating in the MAD system must accept data from OECD members.

Through a multilateral agreement, the MAD system allows participating countries, which includes non-EU members, to share the results of various nonclinical tests carried out on chemicals using OECD methods and principles. Participating countries include the UK, Austria, Belgium, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, the Netherlands, Poland, Portugal, the Slovak Republic, Slovenia, Spain and Sweden. Aims of the MAD system include reduced duplicative testing and allowing governments to work together when assessing chemicals.

It is important to note that the mutual acceptance under the MAD system does not apply to EU member states that are participating in the OECD GLP Compliance Monitoring Programme, but have currently not been successfully evaluated. Example countries include Latvia, Lithuania and Luxembourg. Furthermore, the MAD does not apply to Bulgaria, Croatia, Cyprus, Malta and Romania as they are not participating in the OECD GLP Compliance Monitoring Programme. The European Commission stated that whilst “these EU Member States would have to accept data from the United Kingdom under the MAD system, the United Kingdom would not have to accept data from them.”

To read the European Commission’s notice to stakeholders on withdrawal of the UK and EU rules in the field of GLP, please click here.