Marketing and cessation notification: Regulatory and procedural guidance

HumanRegulatory and procedural guidance

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Overview of comments received on questions and answers on notification to the EMEA of actual marketing and cessation of placing on the market for centrally authorised medicinal products

Reference Number: EMEA/424223/2005

English (EN) (239.53 KB - PDF)

Publicado por primera vez: 23/02/2006 Última actualización: 23/02/2006

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Standard Operating Procedure for marketing status reporting and sunset clause monitoring (Human Medicine)

Adopted Reference Number: SOP/H/3128 Legal effective date: 25/04/2008

English (EN) (303.32 KB - PDF)

Publicado por primera vez: 25/04/2008 Última actualización: 25/04/2008

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Q&A: Marketing and Cessation notification

Marketing and cessation notification: Regulatory and procedural guidance

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