Regulation
Advice
Application Observations
Approval of ATMP
- Modul 0 - Classification of the medicine
- Modul 1 - Medicine identification
- Modul 3A - for somatic cell therapies, biotechnology-engineered tissue products (except for bone marrow or peripheral blood stem cell preparations, which are not substantially processed and intended for non-homologous use) and gene therapy
- Modul 3B - exclusively for stem cell preparations from bone marrow or peripheral blood, which are not substantively processed and intended for non-homologous use
- Modul 4 - Non-clinical data
- Modul 5 - Clinical data
- Flow chart of preparation of stem cell preparations from bone marrow
- Flow chart of preparation of stem cell preparations from peripheral blood
- Quality-determining product properties - Infection test parameters for targeted allogeneic stem cell preparations from peripheral blood, umbilical cord blood and bone marrow
- Quality-determining product properties - Infection test parameters for autologous stem cell preparations from peripheral blood, umbilical cord blood and bone marrow
- Quality-determining product properties - Quality parameters for autologous or targeted allogeneic stem cell preparations from peripheral blood, umbilical cord blood and bone marrow
- Sample infection test parameter list autologous and targeted allogeneic stem cell preparations
- Table template - Quality control data of at least 12 transplants
Notify the Administration of an ATMP not Subject to a Marketing authorisation in a Patient
Approval of Tissue Preparations
- CTD module 1, brief version, capture of drugs data (G-CTD-1) / (German only)
- CTD module 2, brief version, summaries (G-CTD-2) /(German only)
- CTD module 3, brief version, quality (G-CTD-3) / (German only)
- CTD module 4, brief version, non-clinical data (G-CTD-4) / (German only)
- CTD module 5, brief version, clinical data (G-CTD-5) / (German only)
- Notification of change, no approval required (German only)
- Notification of change, approval required (German only)
Batch Testing Human
Blood - Link to overview
Fees
Inspections
Parallel Trade
- Application for a renewal of a marketing authorisation of a product imported in parallel (German only)
- Formular für Parallelimporteure zur Anzeige von Änderungen/zum Antrag auf Zustimmung zu Änderungen (German only)
- Zusatzformular zum Antrag auf Zulassung eines parallel importierten Arzneimittels (German only)
Reference Material
Field Trials Veterinary
- Application for an Exceptional Authorisation of Immunological Veterinary Medicinal Products pursuant to Section 11 (5) Number 1 or 2 Tiergesundheitsgesetz (TierGesG)
- Extension Application for an Exceptional Authorisation of Immunological Veterinary Medicinal Products Pursuant to Section 11(5) Number 1 or 2 Tiergesundheitsgesetz (TierGesG) – Additional Premises –
- Extension Application for an Exceptional Authorisation of Immunological Veterinary Medicinal Products Pursuant to Section 11(5) Number 1 or 2 Tiergesundheitsgesetz (TierGesG) – Additional Batches –
WHO Certificates
- Chargenzertifikat / Batch Certificate of a Pharmaceutical Product (BCPP)
- WHO Certificate for the Batch Release of Immunological Products (BRIP)
- Template: Zertifikat eines pharmazeutischen Produkts / Certificate of a Pharmaceutical Product
- Template: Zertifikat eines pharmazeutischen Produkts / Certificat de produit phamaceutique
- Template: Zertifikat eines pharmazeutischen Produkts / Certificado de un producto farmaceutico
