Abridged / Generic Applications with emphasis on administrative processes and content of the dossier in module 1 

• Essentially similar and informed consent applications
• Bibliographical Application
• Content of the dossier (modules 1, 2 and specific aspects for modules 3 and 4)
• Line-extensions
• Scientific Advice at the BfArM
• The marketing authorization application form
  
  Exercise on the application form

National applications at BfArM (Prüfung nationaler Zulassungsanträge im BfArM)

• Assessment process, e.g. efficacy (Wirksamkeitsprüfung)
• Clinical Trial reports according to Annex one of Directive 2001/83, Clinical Summary and Overview, relevant aspects in the assessment of clinical part of the dossier, fixed combinations
• Summary of Product Characteristics
• Company Core Data Sheet
• Package leaflet and consultation with target patient groups
• Labelling (Kennzeichnung)
• Specific BfArM requirements (Besonderheiten in den Anforderungen des BfArM und zugehörige Bekanntmachungen)
• Labelling principles in national phases of EU procedures 

Specific aspects in marketing applications procedures for herbal and homeopathic medicinal products (AM der besonderen Therapierichtungen)

• Definitions
• Requirements (AMG, AMPrüfRL, pharmacopoeas)
• Possible MAA/registration procedures and required data on S, Q, E
• Herbal medicinal products
• HMPWP
• Botanical nomenclature
• Extracts (labeling)
• Homeopathic medicinal products
• The homeopathic principle, manufacture according to PhEur
• Registration procedure
• Anthroposophical products (brief introduction)

Veterinary products 

• Definitions
• Veterinary Legislation in Germany, EU and globally
• EMEA, CVMP, HMA and CMD(v), VICH, Animal Health Industry Associations
• SPC
• Parts of a Dossier - Part I, II, IIIA Safety, IIIB Residues, IV
• Withdrawal Periods
• Ecotoxicity

Biomedicinal products - specific legal provisions of drug law

• Introduction to PEI
• Biomedicinal products
• Purpose of specific legal rules
• Specific legal provisions at a glance

Vaccines

• Definitions and specific aspects
• Combinations
• Influenza vaccines
• Authorization procedure (brief introduction)
• Vaccine Antigen Master File (VAMF)

7 

Advanced Therapies

• Relevant Directives, Regulations, Guidelines
• Definition and classification: advanced therapy medicinal products, tissue products, combined products
• Authorization procedures
• Incentives