Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Animal Health market in the BRIC countries and comparison of its regulatory requirements for veterinary medicinal products with EU legislation ***

Dr. Sybille Meyer (Abschlußjahr: 2014)

Summary
Today, European companies which produce veterinary medicines prefer to register the major part of their products in several countries of the European Economic Area (EEA) via European procedures, such as the decentralised procedure (DCP), the mutual recognition procedure (MRP), or the centralised procedure (CP). The liberalisation of markets, the increasing global trade with livestock products, and the growing demand for middle-class pursuits such as companion animal bond in the developing countries has resulted in a rising demand for veterinary medicinal products (VMPs) in countries such as Brazil, Russia, India and China (BRIC countries).
In order to successfully register VMPs in the BRIC countries, it is essential to be familiar with the national law and the trends in the veterinary regulatory environment, which will emerge in the near future. Unfortunately, today, the national regulatory law displays a high diversity, the comparableness to the EU legislation is limited, and above all, all of the four BRIC countries have most recently tightened huge parts of their regulatory legislation, For those reasons, the successful authorisation and marketing of VMPs in the BRIC countries have been a great challenge for European companies in the past, and will be even more in the near future.
The aim of this thesis is to give the reader an overview on the animal health (AH) market of the emerging countries Brazil, Russia, India and China. Furthermore, this thesis highlights similarities and differences between the pharmaceutical regulatory environment in the BRIC countries and that in the European Union (EU).
Pages: 70