Centralised procedure procedures

Human

Standard operating procedure for eligibility to the centralised procedure for medicinal products for human use

Adopted Reference Number: SOP/H/3462 Summary:

To describe the process of handling requests for eligibility to the centralised procedure for medicinal products for human use, including the preparation of the eligibility report, the discussion of the requests and report at the CHMP meeting and the preparation and sending of eligibility letters to applicants.

Standard operating procedure for procedure for liaising between the European Medicines Agency, the Committee for Medicinal Products for Human Use (CHMP) and the Clinical Trials Facilitation Group on the potential CHMP ne...

Adopted Reference Number: SOP/INSP/2033 Legal effective date: 29/02/2012 Summary:

Early dialogue between the Agency/CHMP (Co)-Rapporteurs/ Clinical Trials Facilitation Group (CTFG)/National Competent Authorities (NCA) is essential in case CHMP/(Co)-Rapporteurs identify safety issues or lack of efficacy that could lead to a regulatory action with potential impact on any ongoing/completed/future clinical trials.

Standard operating procedure for evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products

Adopted Reference Number: SOP/H/3334 Legal effective date: 02/03/2012 Summary:

This SOP describes the procedure for the evaluation and certification of quality and, where applicable,

non-clinical data submitted by micro, small and medium-sized enterprises developing advanced

therapy medicinal products.

Standard operating procedure for CHMP / CAT / PRAC rapporteur / co-rapporteur / peer-reviewer appointment in the centralised procedure

Adopted Reference Number: SOP/H/3143 Legal effective date: 10/04/2017

Standard operating procedure for rapporteur / co-rapporteur appointment for re-examination of a CHMP opinion

Adopted Reference Number: SOP/H/3175 Legal effective date: 25/09/2012

Standard operating procedure for handling and validation of EU-RMP annex 1

Adopted Reference Number: SOP/H/3291 Legal effective date: 04/02/2011

Work instructions for EU-RMP annex 1: validation

Adopted Reference Number: WIN/H/3292 Legal effective date: 04/02/2011

Veterinary

Standard operating procedure for preparation of an initial European Public Assessment Report (EPAR) for a veterinary medicinal product following positive or negative opinion

Adopted Reference Number: SOP/V/4037 Legal effective date: 10/06/2015

Standard Operating Procedure for updating of the European Public Assessment Report for a veterinary medicinal product

Adopted Reference Number: SOP/V/4038 Legal effective date: 18/12/2015