Module232025

07/05/2025

Practical realities of Article 9

• Generic applications under Article 10(1) • Homeopathic medicines • Herbal medicines

No issue because legal basis is never in doubt

• New developments with established active drugs

• Problematic • Article 10(3) (exempt) vs Article 8(3) (not exempt) • Choice of legal basis lies with applicant… • …but regulators are often reluctant to accept Article 10(3)

The Organisation for Professionals in Regulatory Affairs

11

Article 10

General authorisation requirements

• Provides for the drawing up of detailed arrangements for format and content of applications • You will get much more on this from other presentations

The Organisation for Professionals in Regulatory Affairs

12