FDA Requirements for Packaging
and Labeling
Table of Contents (count.)
- Risk Management Programs: FDA Experience and Evolving
Guidances on Risk Management Practices for Packaging,
Package Inserts and Medication Guides
- Complying with EU Guidelines for Packaging and Labeling:
Determining the effect of the Clinical Trials Directive
[48-51] and the EU Expansion
- Working with CRO's
- Recent Changes in Packaging Requirements
Day 1
EU Guidances
- A Guidance on the readability of the label and packaging
leaflet of medicinal products for human use-European
Commission. Brussels, 29 September 1998
- Notice to Applicants: A guidelines on summary of product
characteristics –
European Commission. December 1999
- Notice to Applicants: Guideline on the packaging information
on medicinal products for human use authorized by the
community-
European Commission. August 2002
- EMEA. The New Product Information linguistic review
process for new applications in the Centralized Procedure
- EMEA Templates Service. QRD (working group on Quality
Review of Documents) – should be on the Eudra.org
website. There is also a “Compliance of QRD decisions
on stylistic matter in product information” & Compilation
of QRD decisions on the use of terms” <More
about this course>
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