EC Explains Brexit’s Impact on GLP

Beginning 1 November, the UK will likely not be a member of the EU. As that date approaches, 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, although an EU-wide “Mutual Acceptance of Data” (MAD) system will apply.

The MAD system, established under the Organisation for Economic Co-operation and Development (OECD), will apply as of the UK’s withdrawal date, and all member states participating in the MAD system must accept data from OECD members, the EC says.

The system is a multilateral agreement allowing participant countries (including non-EU members) to share the results of various nonclinical tests done on chemicals using OECD methods and principles. OECD says the system reduces duplicative testing, allows governments to work together when assessing chemicals and saves government and industry resources.

As an OECD member and a full adherent to the MAD system, the UK joins 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.

But 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 not yet been successfully evaluated (Latvia, Lithuania and Luxembourg).

“While 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,” the EC says.

The MAD system also does not apply to those not participating in the OECD GLP Compliance Monitoring Programme (Bulgaria, Croatia, Cyprus, Malta and Romania).

NOTICE TO STAKEHOLDERS WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF GOOD LABORATORY PRACTICE (GLP)

Good Laboratory Practice