Glossary
The Paul-Ehrlich-Institut has developed the definitions in this glossary to help users understand regulatory and biomedical terminology. Definitions may differ from those given in German and European Union legislation and medicine. Many definitions correspond to the glossary entries on the pages of the European Medicines Agency (EMA).
TEP - Tissue-Engineered Product
Tissue-Engineered Product (TEP): A medicine containing engineered cells or tissues, which is intended to regenerate, repair or replace a human tissue.
Tumor Vaccines
Tumour vaccines are therapeutic vaccines used to treat cancers. They mediate an immune response against cancer cells. Thus, they differ from prophylactic vaccines for the protection against infectious diseases (e.g., measles, influenza, etc.).
Type IA Variation
A minor change to a marketing authorisation that has a minimal or no impact on the quality, safety or efficacy of the medicine and does not require prior approval before implementation by the marketing authorisation holder.
Type IB Variation
A minor change to a marketing authorisation that the marketing-authorisation holder must notify to the regulatory authority before implementation and that can be implemented within 30 days if no objections have been raised, but which does not require formal approval.
Type II Variation
A major change to a marketing authorisation that may have a significant impact on the quality, safety or efficacy of a medicine, but does not involve a change to the active substance, its strength or the route of administration. Type II variations require a formal approval.