Common Contracts
1 similar Mutual Recognition Agreement (Mra) contracts
Mutual Recognition Agreements (MRAs) and Key Elements Status: 18.10.2004Mutual Recognition Agreement (Mra) • October 18th, 2004
Country/ Element Japan Switzerland USA Canada Australia New Zealand Status On 28 April 2004 the European Communities and Japan have exchanged diplomatic notes confirming the completion of the preparatory work under the Mutual Recognition Agree- ment’s Sectoral Annex on GMP for Medicinal Products. Follow- ing this exchange of diplomatic notes, the Sectoral Annex on GMP became operational on 29 May 2004. Under the Sec- toral Annex on GMP for Me- dicinal Products, certificates issued for confirmed manufac- turing facilities in compliance with the GMP requirements of one of the Parties and in accor- dance 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 facili- tate 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 re- view the scope for its possible expansion in the futu
