Biologicals: finished product

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The European Medicines Agency’s scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.

If you have comments on a document which is open for consultation, use the form for submission of comments on scientific guidelines.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Pharmaceutical development

Guidelines


Product information

Guidelines


Points to consider for assessors


Concept papers

Adventitious agents safety evaluation

Guidelines


Position papers and statements

 
Transmissible spongiform encephalopathies (TSEs) (animal and human)

Guidelines


Questions and answers


Position papers, public statements and reports

 
Investigational medicinal products

Guidelines

 
Genetically modified organisms (GMOs)

Guidelines

 
Specifications

Guidelines

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