CRED 8 Presentations

01/07/2024

 Validation, responses to questions and end of procedure: best practice advice

 Real-life procedure timings – where time can be lost in a procedure

The Organisation for Professionals in Regulatory Affairs

23

Key milestones in procedures

3 different application procedures: • National applications (submission in one MS only)* • MRP/DCP applications (submission in more than one MS) • Applications via centralised procedure (submission at EMA)

* Only possible in case no MA has been granted in the EU for the same medicinal product (= same medicinal product means same qualitative and quantitative composition in active substance(s) and having the same pharmaceutical form from applicants belonging to the same mother company or group of companies OR which are "licensees"

The Organisation for Professionals in Regulatory Affairs

24