Good laboratory practice in the European Community. Role of the commission and the member states: external aspects.

The paper recalls the history of the development of the OECD principles of good laboratory practice (GLP) and explains why the European Community has a role to play in the area of GLP. It presents briefly the current legal framework in the European Community (Directives 87/18/EEC and 88/320/EEC) and describes the role of the Commission and the member states in the practical implementation of the GLP principles within the European Community. Impacts of GLP on the relations of the European Community with third countries, both within the framework of the OECD and through bilateral trade agreements (mutual recognition agreements, MRA) based on article 133 of the treaty establishing the European Community, are then examined in greater detail.