Biologicals: finished product
The European Medicines Agency's scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.
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For a complete list of scientific guidelines currently open for consultation, see Public consultations.
- Pharmaceutical development
- Product information
- Adventitious agents safety evaluation viral safety
- Transmissible spongiform encephalopathies (TSEs) (animal and human)
- Investigational medicinal products
- Genetically modified organisms (GMOs)
- Lifecycle management
Points to consider for assessors
Position papers and statements
Questions and answers
Position papers, public statements and reports