Europe

Fifth Sub-committee Meeting, 8 April 2014 Joint Common Statement

April 8, 2014

 The fifth meeting of sub-committee set up under the Joint Committee of the Agreement on Mutual Recognition between the EU and Japan took place through videoconference on 8 April 2014. Members of the sub-committee from both the EU and Japan participated in this meeting.

 The sub-committee reviewed the operation of the Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products of the Agreement on Mutual Recognition between Japan and the EU. It acknowledged that the expansion of the coverage of the Agreement had been identified as a priority and both sides decided to continue their ongoing efforts in this perspective.

 The sub-committee reviewed the work that had been carried out and confirmed steps to be taken to add Competent Authorities. The sub-committee also identified different categories of products for possible inclusion in the scope of the Sectoral Annex on GMP.

 The sub-committee decided that the next meeting of the sub-committee will be held by 31 December 2014.

 Further information on the EU-Japan MRA, Sectoral Annex can be found at:
http://www.ema.europa.eu/emaother site and https://www.mofa.go.jp

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