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.
Tumour Vaccines
Tumour vaccines are therapeutic vaccines that serve to treat cancer diseases and to convey an immune response to cancer cells. In Europe there are currently no centrally – and in Germany also no nationally – authorised medicinal products for cancer treatment that function using active immunisation, a vaccine-typical mechanism of action intended "to produce specific antitoxins and protective agents" against tumours, which would thus be classified as a vaccine pursuant to section 4 subsection 4 of the Medicinal Products Act (Arzneimittelgesetz, AMG).
Therapeutic tumour vaccines are different from prophylactic vaccines, which serve to protect against infectious diseases (e.g. measles or the flu). Prophylactic vaccines also include vaccines against human papillomaviruses (HPV), some of which can cause cancer in humans; these HPV vaccines therefore also indirectly protect against certain cancers.
The term "therapeutic tumour vaccine" is currently not expressly defined in European or German pharmaceutical law. In scientific parlance, this term is understood to mean both certain advanced therapy medicinal products (ATMPs) and certain medicinal products produced using biotechnology (known as biologics).
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.
