Module232025

07/05/2025

Article 38

Rewards and incentives

• PUMAs qualify for 8 + 2 + 1 year of data protection under Reg (EC) 726/2004 or Directive 2001/83/EC depending on MA submission path

In practice, I’m not aware of any PUMAs that were not submitted via the centralised procedure

The Organisation for Professionals in Regulatory Affairs

37

Articles 39 & 40

Rewards and incentives

These articles make provision for additional incentives… …but with very little publicity or apparent result

The Organisation for Professionals in Regulatory Affairs

38