CRED 8 Presentations

08/07/2024

MRP/DCP - Practical Tips Validation Phase – Common reasons for rejection • Application not received/modules missing • Missing/incorrect fee • Application form/cover letter not signed/not signed with original signature

• Application form is incorrect (e.g. information missing, incorrect type of procedure, legal basis incorrect, incorrect reference medicinal product, reference to a European reference medicinal product • Annexes to the application form are missing or absence not justified (eg declaration from the QP, TSE certificates for excipients of animal origin) • Manufacturing licences, GMP certificates not current or missing • ASMF and/or letter of access to ASMF missing or incorrect version of the ASMF has been submitted • Proposed batch releaser is situated outside the EEA KEY POINT: Obtain company feedback on national requirements & align with those on the CMD(h) website (CMDh/043/2007, Rev. 18; lists country specific additional data)

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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MRP/DCP - Practical Tips Validation Phase: National Requirements

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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