EC - Switzerland MRA
The agreement on mutual recognition in relation to conformity assessment has come into operation on 1 June 2002 (OJ L114 on 30/04/2002, amended OJ L68 on 12/03/2003). Chapter 15 details the medicinal products GMP inspection and batch certification.
In order to ensure a proper and uniform implementation and application of Chapter 15 and to allow industry to make the necessary arrangements, an Explanatory Note compliments the MRA text. This note represents the Commission's and the Swiss Authorities' common interpretation of Chapter 15.
However in the practical application further and more detailed interpretation of the Chapter 15 has been requested by industry. Frequently asked questions have been compiled to address issues like territorial application and batch release arrangements. The certificate of GMP compliance for manufactures and batch certificate are posted on this website.
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- Joint Common Statement Jan 2010 The EU and Switzerland agreed to include advanced therapy medicinal products under the current scope of the MRA as of January 2010. Updated on 12 January 2010
- Joint Common Statement Nov 2008 The EU and Switzerland agreed to include APIs in the operational phase under the current scope of the MRA with immediate effect