Post opinion: Regulatory and procedural guidance

Opinion/Decision making

The linguistic review process of product information in the centralised procedure - Human

Reference Number: EMEA/5542/02 Rev. 6

Guidance document on voting in the framework of discussion and adoption of CHMP opinions

Reference Number: CPMP/3137/01 Rev 2

EMEA publication policy of CPMP summaries of opinion

Reference Number: CPMP/1635/01

Procedural advice on the re-examination of CHMP opinions - Obsolete

Draft: consultation closed Reference Number: EMEA/CHMP/50745/2005 Rev.1

Overview of comments received on draft guideline on procedures for re-examination of CHMP opinions

Reference Number: EMEA/CHMP/149558/2006

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

Procedural advice on publication of information on negative opinions and refusals of marketing authorisation applications for human medicinal products

Adopted Reference Number: EMA/599941/2012

Overview of comments received on the reflection paper on publication of CHMP negative opinion and refusal of marketing authorisation applications for human medicinal products

Reference Number: EMEA/482219/2006

• Decision Making Procedure for the Adoption of Commission Decisions, the Rules governing Medicinal Products in the European Community, Notice to Applicants, Volume 2A, Chapter 6

EPAR

Reflection paper on European public assessment report summary for the public

Adopted Reference Number: EMEA/126757/2005

Overview of comments received on reflection paper - EPAR summary for the public

Reference Number: EMEA/20722/2006

Standard operating procedure for preparation of a European public assessment report for a human medicinal product following positive or negative opinion

Adopted Reference Number: SOP/H/3003 Legal effective date: 12/09/2012

Standard operating procedure for preparation and updates of European public assessment report summaries by Product-related Information to the Network Service

Adopted Reference Number: SOP/H/3131 Legal effective date: 28/03/2014