Initial evaluation procedures

Human

Standard Operating Procedure for handling of a request for accelerated assessment of initial marketing authorisation applications (human use)

Adopted Reference Number: SOP/H/3182 Legal effective date: 05/01/2009

Standard operating procedure for consultation of environmental competent authorities on genetically modified organisms with respect to environmental risk assessment in product evaluation (human use)

Adopted Reference Number: SOP/H/3191 Legal effective date: 20/12/2019

Standard operating procedure for consultation of environmental competent authorities on genetically modified organisms with respect to environmental risk assessment in product evaluation (human use) - Forms 1-7

Veterinary

Standard operating procedure for evaluation procedure for veterinary medicines initial marketing authorisation procedures and extensions

Adopted Reference Number: SOP/V/4110 Legal effective date: 16/01/2018

Work instructions for checking of MRL status of constituents of veterinary medicinal products subject to a marketing authorisation application to the EMA

Adopted Reference Number: WIN/V/4046

Work instructions for handling of withdrawals of applications for marketing authorisation of veterinary medicines

Adopted Reference Number: WIN/V/4031 Legal effective date: 15/05/2014 Summary:

Work instructions for handling of withdrawals of applications for marketing authorisation of veterinary medicines

Standard operating procedure for evaluation of veterinary medicinal products containing or consisting of genetically modified organisms

Adopted Reference Number: SOP/V/4012 Legal effective date: 05/02/2015

Standard Operating Procedure for SIAMED-related data validation of new veterinary centralised procedures

Adopted Reference Number: SOP/V/4033 Legal effective date: 26/04/2010

Standard operating procedure for involvement of the CVMP Antimicrobials Working Party in the evaluation of applications for centralised marketing authorisations for veterinary medicinal products containing antimicrobial substances

Adopted Reference Number: SOP/V/4042 Legal effective date: 01/10/2014