CRED Getting the CMC Dossier Right 2024

28/08/2024

Certificates of Suitability (CEP)

Submit to Certification of Substances Division (DCEP);

● Application form + Fee

● QOS

● Module 3.2.S (eCTD format)

● Samples

Two assessors

Technical advice prior to/during assessment

The Organisation for Professionals in Regulatory Affairs

39

Non-Pharmacopoeial DS

Dir 2001/83/EC (Annex 1, Part 2, C) states:

● “Constituents….not given in any pharmacopoeia shall be described in the form of a monograph..”

The Organisation for Professionals in Regulatory Affairs

40

20