EMA GVP Product- or population-specific considerations:

The guideline on GVP is divided into chapters; Each chapter and revisions are developed by a team consisting of experts from EMA and from EU Member States.

The chapters on product- or population-specific considerations are available for vaccines, biological medicinal products and the paediatric population.

Click on the titles below for complete guidelines

Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases

Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations II: Biological medicinal products

Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations IV: Paediatric population

EMA GVP Product or population specific considerations: