Spring Intro 2023

03/03/2023

Conclusions

• EU regulations are a “ must ” • Guidelines are “ should” – you need to comply, but deviation(s) can be accepted if scientifically justified and well presented in the Dossier • Use experience from previous procedures • Not sure would your approach be acceptable in MAA? • Use national/EMA Scientific Advice (and protocol assistance) • Presentation of data in the Dossier

• Well presented and documented Dossier • Follow NtA/CTD Guidance document

Good science prevails!

03/03/2023

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Useful links

• Eudralex - link • Volume 2B Notice to Applicants Medicinal products for human use - link • EMA - link • ICH – link (CTD – ICH M4) • CMDh – link (Procedural Guidance) • European Pharmacopoeia – link (subscription required) • EC Guideline on SmPC – link • QRD Template – link • HPRA-link

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