CRED 8 Presentations

08/07/2024

Initial Registration Strategy choosing the registration path

MRP

DCP

Optional scope

Mandatory Scope

1. Products from certain biotechnological processes 2. Advanced therapy 3. Cancer 4. Neurodegenerative disorder 5. Diabetes 6. Auto-immune diseases and other auto-immune dysfunctions

• New active substances; • Generic medicinal products; • Informed consent applications; • Bibliographic applications; • Known substances in new combinations; • Existing substance with significant therapeutic, scientific or technical innovation; • Herbal medicinal products; • Homeopathic products

7. Viral diseases 8. Orphan Drugs

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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Initial Registration Strategy choosing the registration path

Medicinal product

Yes

CP Mandatory

CP

No

License required in single country or multiple countries

Single

Optional scope

National

Multiple

Is the product licensed anywhere in the EU already?

Yes

No

DCP

MRP

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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