Spring Intro 2023

Background slides

TOPRA Spring Introductory Course 2023

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Important references

• Notice to Applicants, Volume 2A, Chapter 5 Variations / Chapter 7 •

CMD(h) Best Practice Guides (BPG) for the Submission and Processing of Variations in the Mutual Recognition Procedure (also applies to national only procedures; April 2013 and subsequent chapter updates) • European Medicines Agency post-authorisation procedural advice for users of the centralised procedure • Guideline on the Categorisation of Extension Applications vs. variation applications • EMEA Procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 EMEA/588416/2008 • ICH Q12 TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT

The Organisation for Professionals in Regulatory Affairs

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