Module232025

07/05/2025

Article 8

General authorisation requirements

Article 7 also applies to:

• New indications • New Routes of administration • New pharmaceutical forms

…if the drug concerned is under patent or protected by a supplementary patent certificate

!

The Organisation for Professionals in Regulatory Affairs

9

Article 9

General authorisation requirements

The legal basis for a future MAA is crucial because all the following are exempt:

• Abridged applications • Bibliographic applications • Homeopathic medicines • Traditional herbal medicines

The Organisation for Professionals in Regulatory Affairs

10