Contents

• Question 1 2
• Regulatory Routes for Registration of the product in European Union 2
• National Authorization Procedures 2
• Decentralized Procedure 3
• Mutual Recognition Procedure 5
• Centralized procedure 6
• Optimal Procedure 8
• Risk Management Plan 8
• Paediatric Investigation Plan 9
• Alternate Strategy for Market Authorisation 9
• References 11
• Question 2 13
• Pharmacovigilance Legislation 13
• Main drivers of the new EU Pharmacovigilance Legislation 15
• References 20

Description

This report is based on the following requirement -
Question (1) word limit 2000 words
You are the Director of European Regulatory Affairs for a global pharmaceutical company.
Your company has a new chemical entity (NCE) [Trade mark ZIPPOTM] for congestive heart failure (not a
biotechnology product or orphan drug) that it wishes to register in all 25 member states of the EU. The
Marketing Application will be filed in December 2014.
Your Company intends to:
• co-market the product with Menarini in Italy
• co-market the product with Almirall-Prodesfarma in Spain
• co-promote the product with Astra-Zeneca in Sweden
• sell the product in all Member States of the European Union and Iceland and Norway.
•
• Discuss the regulatory routes available for the registration of your product in the European Union andidentify the main advantages and disadvantages of each route for this product taking account of the comarketing/co-promotion requirements above.
• Identify the optimal procedure and provide a reasoned argument for your choice. You should also include specific details of your Risk Management Plan and Paediatric Investigation Plan, as considered appropriate. Discuss your strategy should your choice of procedure fail.
Question (2) word limit 2000 words
Describe and discuss the main drivers for the new EU pharmacovigilance legislation