Governance procedures

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 ...

Adopted Reference Number: SOP/EMA/0129 Legal effective date: 01/08/2017

Work instructions for preparing notices for publication in Official Journal of the European Union (OJEU)

Adopted Reference Number: WIN/EMA/0133 Legal effective date: 18/04/2013

Standard operating procedure for evaluation procedure for eligibility of patients', consumers' and healthcare professionals’ organisations

Adopted Reference Number: SOP/H/3390 Legal effective date: 13/03/2015 Summary:

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.

Standard operating procedure for re-evaluation and financial re-assessment procedures for eligible patients', consumers' and healthcare professionals’ organisations

Adopted Reference Number: SOP/H/3417 Legal effective date: 13/03/2015 Summary:

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.

Standard operating procedure for handover file

Adopted Reference Number: SOP/EMA/0127 Legal effective date: 01/04/2013 Summary:

Standard operating procedure on hand over files

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

Adopted Reference Number: SOP/EMEA/0101 Legal effective date: 01/06/2023

Standard operating procedure for cover during out of Agency office hours for a potentially serious problem with a centrally authorised product

Adopted Reference Number: SOP/EMA/0087 Legal effective date: 08/12/2010

Standard operating procedure for Management Board consultation on new nominations to the CHMP and the CVMP

Adopted Reference Number: SOP/EMEA/0076 Legal effective date: 31/01/2013