Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)

Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)

Human medicines European public assessment report (EPAR): Cinqaero, reslizumab, Date of authorisation: 15/08/2016, Revision: 12, Status: Authorised

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Human medicines European public assessment report (EPAR): Edurant, rilpivirine, Date of authorisation: 28/11/2011, Revision: 22, Status: Authorised

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Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template" - Scientific guideline

Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template" - Scientific guideline

Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies

Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies

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