Volume 7: Medicines and Cosmetics
Table of Contents

1 Introduction and overview
   Scope of this volume
   Animal and human medicines
   Cosmetics
   Audit of uses of bovine tissues
   Overview and general findings

2 The operation of medicines licensing
   Introduction
   The licensing regime for human and veterinary medicinal products
   Responsibilities for medicines licensing in 1988/89
   Evaluation of the arrangements for the control of medicines
   New structures responsible for medicines licensing
   Regulation of medical devices
   Annex 1 to Chapter 2: Examples of bovine materials used in medicines
   Annex 2 to Chapter 2: Outline of production processes for vaccines and injectable medicinal products

3 Initial response on veterinary medicines
   Introduction
   Use of animal materials prior to the emergence of BSE
   Consideration of BSE in MAFF from January 1987 to March 1989: a chronological account
   Conclusions on MAFF's initial response

4 Initial response on human medicines
   Early knowledge of BSE within Medicines Division
   Consideration of BSE in Medicines Division from January 1988 to March 1989: a chronological account
   Discussion

5 Issue of guidelines
   Introduction
   Preparation and issue of joint guidelines between January and March 1989: a chronological account
   Guidelines on medical devices
   Discussion

6 Ensuring medicinal products complied with the guidelines
   Introduction
   Responsibility for managing the process
   March 1989-March 1996: a chronological account
   1989
   1990
   1991-92
   1993-96
   Discussion

Annex 1 to Chapter 6: People attending the BSE Working Group

Annex 2 to Chapter 6: Response to the Questionnaires

Annex 3 to Chapter 6: Veterinary medicines that did not comply with the 1989 CSM/VPC guidelines

Annex 4 to Chapter 6: Human vaccines that did not comply with the 1989 CSM/VPC guidelines

7 The Tyrrell proposals for research into pharmaceuticals
   Introduction
   BSE-related pharmaceuticals research: a chronology
   Discussion

8 Cosmetics and toiletries
   Introduction
   Regulatory framework
   Cosmetics and BSE - a chronology
   1992
   1993
   1994
   1995
   1996
   1997/98
   Discussion

9 Consideration of an audit of the uses of cattle tissues
   Introduction
   Consideration of an audit into the fate of cattle tissues: a chronology
   1988/89
   1990
   1991
   1992
   1995
   1996
   Discussion
   Annex 1 to Chapter 9: The cattle carcass: routes of use in the late 1980s
   Annex 2 to Chapter 9: Uses made of the cattle carcass

Glossary

Who's who

Index