Standard operating procedure for handling of information from external sources disclosing alleged improprieties concerning EMA activities on the authorisation, supervision and maintenance of medicinal products for human ...
English (EN) (595.95 KB - PDF)
Work instructions for preparing notices for publication in Official Journal of the European Union (OJEU)
English (EN) (120.81 KB - PDF)
Standard operating procedure for evaluation procedure for eligibility of patients', consumers' and healthcare professionals’ organisations
The purpose of this SOP is to ensure a consistent and efficient approach in the evaluation procedure for eligibility criteria of patients', consumers' and healthcare professionals’ organisations applying to be involved in the activities of the Agency.
English (EN) (174.64 KB - PDF)
Standard operating procedure for re-evaluation and financial re-assessment procedures for eligible patients', consumers' and healthcare professionals’ organisations
The purpose of this SOP is to ensure a consistent and efficient approach in the re-evaluation procedure
for eligibility criteria of patients', consumers' and healthcare professionals’ organisations involved in the activities of the Agency.
English (EN) (218.8 KB - PDF)
Standard operating procedure for handover file
Standard operating procedure on hand over files
English (EN) (274.2 KB - PDF)
Standard operating procedure for conducting checks for conflicts of interest of the European Medicines Agency employees assigned duties relating to medicinal products for human or veterinary use
English (EN) (462.97 KB - PDF)
Standard operating procedure for cover during out of Agency office hours for a potentially serious problem with a centrally authorised product
English (EN) (196.67 KB - PDF)
Standard operating procedure for Management Board consultation on new nominations to the CHMP and the CVMP
English (EN) (449.88 KB - PDF)