Initial evaluation procedures

Human

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

AdoptedReference Number: SOP/H/3182Legal 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)

AdoptedReference Number: SOP/H/3191Legal 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

AdoptedReference Number: SOP/V/4110Legal 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

AdoptedReference Number: WIN/V/4046

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

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

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

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

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

AdoptedReference Number: SOP/V/4033Legal 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

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