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

April 28, 2004

The Agreement on the Mutual Recognition (MRA) between the European Community (EC) and Japan, which entered into force in January 2002 as the first bilateral MRA for Japan, includes 4 Sectoral Annexes as its integral parts. Out of 4 Sectoral Annexes to the Agreement, only the Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products (hereinafter "the GMP Annex") has not applied so far.
The European Commission and the Mission of Japan to the European Union exchanged today diplomatic notes for the application of the GMP Annex. Following this exchange of the notes, the GMP Annex will become applicable on 29 May 2004.
The importing Party will exempt the importers of medicinal products manufactured in the exporting Party from testing of such medicinal products. The two Parties expect that trade in pharmaceutical sector between them will be facilitated through the reduction of costs because of such exemption.
After a series of discussion between the experts from both sides about the scope of medicinal products subject to the GMP Annex, the Parties have reached the conclusion shown in the attachment. The Parties will review the scope for its possible expansion in the future.

Note 1:

The Agreement provides a framework to enable the exporting Party to undertake certain procedures required in the importing Party in trade between the EC and Japan. The Agreement is aimed at promoting trade between them in the specific sectors by reducing the burden for companies engaged in such trade.

Note 2:

The Agreement applies to four sectors, namely "Telecommunication Terminal Equipment and Radio Equipment", "Electrical Products", "Good Laboratory Practice (GLP) for Chemicals", and "Good Manufacturing Practice (GMP) for Medicinal Products". As the sector on GMP for Medicinal Products may affect the human health, the Agreement stipulates that the GMP Annex shall not be applied before the completion of the preparatory work such as re-confirmation of the equivalence of the GMP requirements and their implementation between the Parties.

ATTACHMENT

Scope of the Medicinal Products subject to the GMP Annex

Chemical pharmaceuticals are covered by the GMP Annex.
Homeopathic medicinal products are covered by the GMP Annex as long as they are treated as drugs and subject to GMP requirements in Japan.
Vitamins, minerals and herbal medicines are covered by the GMP Annex if they are considered as medicinal products in both Parties.
Medicinal gases, in-vitro diagnostics, blood, plasma and any unstable medicinal products derived from human blood or plasma are not covered as they are not treated as medicinal products or not subject to GMP requirements in the Parties.
Biological pharmaceuticals, including immunologicals and stable medicinal products derived from human blood or plasma, and sterile medicinal products are currently not covered by the GMP Annex as the equivalence of their GMP requirements has not been reconfirmed, but may be covered in the future.
Medicinal products for clinical trials and active pharmaceutical ingredients are currently not covered by the GMP Annex, but may be covered in the future.

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