CRED 8 Presentations

08/07/2024

Key dates and legislation

1993

Directive 93/39/EEC

MRP implemented. Duplicate assessments forbidden. Preparation and exchange of AR. CPMP re established as adjunct to EM(E)A.

2001

Directive 2001/83 /EC

MAs reviewed in 210 days

2004

Directive 2004/27/EC

DCP implemented. MRP and DCP Coordination group established.

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

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Understanding the opportunities and challenges of the MR/DC Procedures

Commercial Strategy

Regulatory requirements

Registration Path

National Licence In single country

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

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