Spring Intro 2023

16/02/2023

Legal Basis For Abridged Applications

Legal Basis Article 10(1) Article 10(3) Article 10(4)

Type of MAA

Abridged Application?

Generic Hybrid

Y Y Y N

Biosimilar

Article 8(3) Article 10a Article 10b Article 10c

Full file

Well established use Fixed dose combination

N* N* N*

Informed consent

*Utilise an abbreviated data package but are not true “abridged applications”

The Organisation for Professionals in Regulatory Affairs

5

DCP – Started Procedures By Legal Basis

CMDh statistics – DCPs started in 2022 by legal basis

Type

No of Procedures

Full dossier

27

Generic 808 Well established use 96 Hybrid 188 Fixed combination 25 Traditional herbal 5 Informed consent 2 Similar biological 2 TOTAL: 1153

The Organisation for Professionals in Regulatory Affairs

6