Centralised procedure procedures

Human

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

AdoptedReference Number: SOP/H/3462Summary:

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...

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

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

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

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

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

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

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

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

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

Work instructions for EU-RMP annex 1: validation

AdoptedReference Number: WIN/H/3292Legal 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

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

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

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