Sunset clause monitoring: Regulatory and procedural guidance
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Overview of comments received on questions and answers on the application of the so-called 'Sunset clause' to centrally authorised medicinal products (PDF/207.7 KB)
First published: 23/02/2006
Last updated: 23/02/2006
EMEA/424409/2005 -
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Standard Operating Procedure for marketing status reporting and sunset clause monitoring (Human Medicine) (PDF/303.32 KB)
Adopted
First published: 25/04/2008
Last updated: 25/04/2008
Legal effective date: 25/04/2008
SOP/H/3128