Exchange of Diplomatic Notes to amend the Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products to the Agreement on the Mutual Recognition between Japan and the European Community

April 25, 2016
Japanese

  1. 1. On Friday, April 22, exchange of Diplomatic Notes to amend the Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products to the Agreement on the Mutual Recognition between Japan and the European Community (EC) (hereinafter referred to as “the Agreement”) (note 1) took place in Brussels between Ambassador Keiichi Katakami of Japan to the EU and Mr. Jean-Luc Demarty, Director General for Trade, European Commission.

    2. In response to the expansion of the EU since the Agreement entered into force in January 2002, the Sectoral Annex on GMP for Medicinal Products was amended to include competent authorities of the new Member States (note 2) to the EU which were not included in the Agreement.

    3. With the amendment, Japan will exempt the importers of medicinal products manufactured at the facilities confirmed by the competent authorities of the new Member States to the EU from testing of such medicinal products. The trade in pharmaceutical sector between Japan and the EU is expected to be facilitated through the reduction of costs due to such exemption.

    (note 1) In accordance with the Exchange of Notes Verbales between Japan and the EU (Note Verbale presented by Japan dated June 21, 2010 and Note Verbale presented by the EU dated July 5, 2010), the word “European Community” in the Agreement shall be replaced with “European Union.”

    (note 2) Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, Slovenia, Bulgaria, Romania and Croatia