Module 1 2021

01/07/2021

The key measures included in the regulation;

• Setting up an expert committee; PDCO • Requiring companies to submit data on the use of a medicine in children (article 45 and 46) • Submission of a paediatric investigation plan by the applicant (PIP) • PIP compliance when applying for marketing authorization for medicines and line-extensions for existing patent- protected medicines • Possibility of a Paediatric specific MA (PUMA), for new Paediatric indications for off patent products

The Organisation for Professionals in Regulatory Affairs

9

Obligaties versus incentives:

The Organisation for Professionals in Regulatory Affairs

10

5