Product Type: Market Research Report
Published by: Informa Healthcare
Published: June 2007
Product Code: R3535-53Description The regulation of veterinary pharmaceutical products worldwide continues to become more demanding and increasingly complex, especially in Europe.This report, which has two volumes, is aimed at anyone who needs to understand the basics of the regulations. It provides information on how to plan for the acquisition of a veterinary pharmaceutical product approval in the region in question.
Key coverage- Learn the different procedures and processes that you can apply for and how to apply for them.
- Understand how to get a product from the lab to the market effectively and efficiently.
- Use Volume 2 of the report to guide you through the the application processes - with invaluable do’s and don’ts to help make a more favorable impression.
- Examine national market profiles including major market segments and future market prospects.
- Find out the procedures for renewals, variations & extensions, generics and good practice guidelines and more - providing you with a one stop resource.
Key issues- You will learn that you can submit your application for approval in only one European country, or in any number of territories.
- Alternatively, you can seek a simultaneous approval throughout the EU and not the European Economic Area in the Centralised Procedure (CP).
- You will understand that knowing what your product is, and where your priority markets are, will condition which procedure you select.
- You will have a practical guide to completing an application as Volume 2 talks you through the entire process from start to finish.
Chapters include:
Legal Framework, principle legal texts on regulatory procedures in the EU, procedures for obtaining authorisations issued by member states, procedure for obtaining community authorisations, European drug master file and certificate of suitability, other Issues, renewals variations and extensions, batch release in Europe pharmacovigilance, pharmacopoeias, European good manufacturing practice, good laboratory practice, good clinical practice, Maximum Residue Limits, generic veterinary medicines.
Who should read this report?- Newcomers to the regulatory profession
- Non-European generics manufacturers
- Drug developers wanting to market their products in Europe
- New member European States
Please Note: This product is delivered as a zip file, which contains PDF files.Table of Contents - VOLUME 1
- 1.Legal Framework
- 2.Principle Legal Texts on Regulatory Procedures in the EU
- 3.Procedures for Obtaining Authorizations Issued by Member States
- 4.Procedure for Obtaining Community Authorizations
- 5.European Drug Master File and Certificate of Suitability
- 6.Other Issues
- 7.Renewals
- 8.Variations and Extensions
- 9.Batch Release in Europe
- 10.Pharmacovigilance
- 11.Pharmacopoeias
- 12.European Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products Guidelines
- 13.European Good Manufacturing Practice
- 14.Good Laboratory Practice Requirements in Europe
- 15.Good Clinical Practice
- 16.Maximum Residue Limits
- 17.Generic Veterinary Medicines
- 18.Useful Websites
- VOLUME 2
- 1.Framework of Marketing Authorization Application
- 2.Part II: Quality
- 3.Part IIIA: Safety
- 4.Part IIIB: Residues
- 5.Part IV: Efficacy
- 6.Laying Out the Marketing Authorization Application
- 7.Part I in Depth
- 8.Part II in Depth
- 9.Part IIIA in Depth
- 10.Part IIIB in Depth
- 11.Part IV in Depth
- 12.Assembling the Marketing Authorization Application
- 13.Data Requirements for Generic Applications
- 14.Useful Websites
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