Abstract
“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.
Products and companies covered
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?
- Non-European generics manufacturers
- Drug developers wanting to market their products in Europe
- New member European States
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