CRED 8 Presentations

03/07/2024

Legal basis of the application in EU

Article 10 of Directive 2001/83/EC

Article

Type of application

8 (3)

Full or full-mixed application (complete dossier)

10 (1) 10 (3) 10 (4)

Generic

Hybrid/Line Extension Similar biologic/Biosimilar

10a 10b 10c 16.a

Well established use application (literature only)

Fixed dose combination (components already authorised separately)

Informed consent

Traditional use herbal medicines

The Organisation for Professionals in Regulatory Affairs

5

Abridged applications (generic, hybrid, biosimilar)

Opening statement within Article 10: 'By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials, if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than 8 years in a Member State or in the Community’ • Derogation from the requirements for a full MAA • Development vs a Reference Medicinal Product, which has been granted MA in the Union (non-EU/EEA cannot be used as a reference product) on the basis of a full dossier • Submission only possible once data protection period of reference medicinal product has expired • Access to centralised procedure - automatic access if reference medicinal product is a centrally authorised product

The Organisation for Professionals in Regulatory Affairs

6

3