Japan-EU Relations

Japan-EC[Note] Mutual Recognition Agreement (MRA)

July 18, 2018
Japanese

The Agreement on Mutual Recognition between Japan and the European Community (EC) establishes a framework which enables certain procedures required in the importing country to be undertaken in the exporting country in the sectors of telecommunications equipment, electrical products, good laboratory practice (GLP) for chemicals and good manufacturing practice (GMP) for medicinal products, and in this way aims to promote trade between Japan and the EU by reducing the cost for companies that are engaged in trade in the four areas.

This agreement, which came into force on 1 January 2002, is the first bilateral agreement on mutual recognition for Japan. In April 2016, the Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products was amended. Subsequently, in July 2018, the operational scope of medicinal products was agreed to include the product categories such as chemical pharmaceutials, active pharmaceutical ingredients, biological medicines and herbal medicines and so on under certain conditions agreed by both Parties.

[Note] In accordance with the Exchange of Notes Verbales between Japan and the EU in 2010, the word "European Community" in the Agreement was replaced with "European Union."

Agreement on Mutual Recognition between Japan and the European Community