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GMP News No. 422
26 May 2004
Latest News on MRA Agreements
The Mutual Recognition Agreements (MRAs) are the basis for the mutual recognition of GMP inspections. Recently there have been two new developments in this area published on the Pharmacos website which we will summarise in the following.
1. Operational phase of the EC-Japan Mutual
Recognition Agreement will
On 28 April 2004 the European Communities and Japan have exchanged diplomatic notes confirming the completion of the preparatory work under the Mutual Recognition Agreement's Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products. Following this exchange of diplomatic notes, the Sectoral Annex on GMP will become operational on 29 May 2004. Under the Sectoral Annex on GMP for Medicinal Products, certificates issued for confirmed manufacturing facilities in compliance with the GMP requirements of one of the Parties and in accordance with the provisions of the MRA will be accepted in the EC and Japan without additional testing. Therefore, both parties expect that the MRA will facilitate trade between the Parties by reducing costs for companies. For the moment the Sectoral Annex will cover a limited number of human medicinal products. The Parties will review the scope for its possible expansion in the future.
Please click here in order to read more about the MRAs.
2. Impact of MRAs to new Member States following accession
2.1 Impact on imports from MRA partners
2.2 Impact on exports to MRA partners
2.3 The way forward for mutual recognition of GMP
If you would like to read the "Note on GMP Sectoral Annexes in MRAs" and about its impact on the new Member States, please click here.