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Legal requirements for generics and abridged products and bioequivalence

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This document summarizes key concepts related to legal requirements for generic and abridged drug products, including definitions, regulations, bioequivalence, and pros and cons of generic drugs. It discusses definitions of innovator products, generic medicines, pharmaceutical equivalence and alternatives. It also covers requirements for generic drug applications, marketing authorizations, and the need to demonstrate bioequivalence to the reference product through appropriate studies. Guidelines for bioavailability and bioequivalence studies from regulatory authorities are mentioned.

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Legal Requirements for Generics and Abridged Products and Bioequivalence I.Kanzik IDE PharmaConsult PharmaCon 2007 May 22 – 27, 2007 DUBROVNIK, Hotel Dubrovnik Palace
TOPICS ,[object Object],[object Object],[object Object],[object Object]
Career in Pharmacy ,[object Object],[object Object],[object Object]
Pharmaceutical Industry ,[object Object]
Regulatory Affairs ,[object Object],[object Object]
[object Object],[object Object],[object Object]
[object Object]
Three important requirements for Registration of NCE ,[object Object],[object Object],[object Object]
I nnovator P roduct ,[object Object]
Marketing Authorization I nnovator product ,[object Object],[object Object],[object Object],[object Object]
Drug Registration ,[object Object]
International Conference on Harmonisation ,[object Object]
EU Regulations ,[object Object]
2004/27/EC: Article 10.1: Reference and Generic Products ,[object Object]
Generic Medicines ,[object Object]
GENERIC APLICATIONS CONTENT OF THE FILE ,[object Object],[object Object],[object Object],[object Object]
Marketing Authorisation Generics ,[object Object],[object Object]
Essentially similar products European Court of Justice ,[object Object]
Essentially similar products ,[object Object]
[object Object]
ECJ Case C-74/03 of January 2005: Active Substance in Different Forms of Salt ,[object Object],[object Object],[object Object],[object Object],[object Object]
Article 10a: Well Established Medicinal Use ,[object Object],[object Object]
Generic drugs Bioequivalence ,[object Object],[object Object]
GENERIC APLICATIONS ,[object Object]
Pharmaceutical Equivalence ,[object Object],[object Object],[object Object]
Pharmaceutical Alternatives ,[object Object],[object Object]
Therapeutic E quivalence ,[object Object],[object Object],[object Object],[object Object],[object Object]
BIOAVAILABILITY (according to EU guidance note) ,[object Object]
BIOEQUIVALENCE (according to EU guidance note) ,[object Object]
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[object Object],[object Object]
Bioavailability/Bioequivalence Guidelines ,[object Object]
Global harmonisation ,[object Object],[object Object]
Differences among the authorities ,[object Object],[object Object]
[object Object]
Pros of generic drugs ,[object Object]
Cons of generic drugs ,[object Object]
Cons of generic drugs ,[object Object]
Cons of generic drugs ,[object Object],[object Object]
[object Object]
Substitution ,[object Object],[object Object]
[object Object]

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Legal requirements for generics and abridged products and bioequivalence

  • 1. Legal Requirements for Generics and Abridged Products and Bioequivalence I.Kanzik IDE PharmaConsult PharmaCon 2007 May 22 – 27, 2007 DUBROVNIK, Hotel Dubrovnik Palace
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