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

Summary:

Volume 1 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 the region in question. If the reader’s background is in drug discovery, development, manufacture or sales and marketing, this report can help one to understand how a regulatory submission must be planned and carried out to achieve a timely marketing approval. The regulations are most complex in Europe and so the report focuses closely on the requirements in the European Union. . . . European Licensing Procedures The regulatory procedures used will be explained in detail. These include national applications in only one territory, multiple applications in more than one territory, mutual recognition of national applications throughout the EU and centralized applications that are made by way of the European Medicines Agency (EMEA) in London. Selection of the most appropriate procedure has implications on marketing objectives. Other European procedures, data requirements and the writing of the European submission will be covered in Volume II of this report. If, after reading the two volumes of this report, someone were to ask you: ‘Which regulatory procedure should I use in Europe?’ you will be able to reply: ‘First, what are your commercial objectives? And, second, it depends on the nature of your product.’ You will also 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 the European Economic Area in the Centralized Procedure (CP). Not all procedures are open to all products; in some cases the CP is not permitted, in some cases, its use is mandatory. So, knowing what your product is, and where your priority markets are, will condition which procedure you select. Volume 2 The regulation of veterinary pharmaceutical products worldwide continues to become more demanding and increasingly complex, especially in the European Union (EU). This report, which has two volumes, is aimed at anyone who has two goals: to understand the basics of the regulations and to learn more about submitting an application for market authorization. The first volume was the theoretical part, outlining the legislation and guidelines in place within Europe. This volume is the practical part, giving detailed explanations and practical tips on submitting an application for a market authorization. Hence, the focus of this volume is the application itself, which has four parts. These are Part I (dossier summary); Part II (quality); Part III (safety and residues); and Part IV (efficacy). This volume first describes the requirements of each section. It then tells you how to write and present the various parts of the application. You are led carefully through what may seem a labyrinthine process and are offered advice on how to draft and present your product’s application. The report begins with a description of the framework of the marketing authorization application (MAA). It goes on to give a breakdown of the documentation required by each part and offers guidance on what may or may not please the assessors. Also covered is the MAA process for generic drugs.