ABSTRACT

Provides a systematic account of the major technical, administrative and legal requirements for registering a product in any of the national markets within the EEC, using the existing procedures, with guidance as to how these procedures are likely to change after 1992.

chapter 6|15 pages

Abridged applications

chapter 7|9 pages

Drug master files

chapter 8|18 pages

Radiopharmaceutical products

chapter 9|40 pages

Medicated devices

chapter 14|18 pages

CPMP multistate procedure