CRED 8 Presentations

01/07/2024

Module 1.8.1 Pharmacovigilance system (CP, MRP and DCP)

‘This is a detailed description of the pharmacovigilance system which the applicant will introduce’ Notice to Applicants Description includes: • Details on Qualified Person for Pharmacovigilance (name and address and EU country of residence) • Confirmation that the applicant has the necessary means to fulfil the tasks and responsibilities set out in the Title IX of Directive 2001/83/EC. • Location of Pharmacovigilance System Master File

The Organisation for Professionals in Regulatory Affairs

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Module 1.8.2 Risk-management System (CP, MRP and DCP)

• EU Risk Management Plan (RMP) included in this section. Consists of the following parts: • Part I Product Overview • Part II Safety Specification • Part III Pharmacovigilance Plan (including post authorisation safety studies) • Part IV: Plans for post-authorisation efficacy studies • Part V: Risk minimisation measures (including evaluation of the effectiveness of risk minimisation activities) • Part VI: Summary of the risk management plan Reference: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance format-risk-management-plan-rmp-eu-integrated-format-rev-201_en.pdf

The Organisation for Professionals in Regulatory Affairs

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