Product information

Work instructions for secretarial tasks for initial preparation and update of veterinary European public assessment reports (EPARs)

Adopted Reference Number: WIN/V/4035 Legal effective date: 08/02/2016

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 certificates of medicinal products

Adopted Reference Number: SOP/INSP/2000 Legal effective date: 03/04/2012 Summary:

Enabling the production of the European Medicines Agency (EMA) certificates of a medicinal product for human and veterinary use in a consistent way.

Work instructions for recording, validation and production of certificates of medicinal products

Adopted Reference Number: WIN/INSP/2029 Legal effective date: 03/04/2012 Summary:

Hard copies of requests for Certificates of Medicinal Product (CMP) and all related correspondence are stored in the Certificates office for at least three months and after that archived off site for 10 years.

Standard operating procedure for preparation, dissemination and publication of safety-related European Medicines Agency press releases and question-and-answer documents

Adopted Reference Number: SOP/EMA/0111 Legal effective date: 12/04/2011

Work instructions for sending of lines to take and safety-related information to the European Union regulatory network and international partners

Adopted Reference Number: WIN/H/3210 Legal effective date: 12/04/2011

Standard operating procedure for early notification system: procedure for advanced notification of emerging safety issues to European Union regulatory network and international partners

Adopted Reference Number: SOP/H/3346 Legal effective date: 13/04/2011

Standard operating procedure for preparation of ‘lines-to-take’ documents for use within the European Union regulatory network to answer external queries in a consistent manner

Adopted Reference Number: SOP/H/3347 Legal effective date: 13/04/2011

Standard operating procedure for Product Information Quality / Quality Review of Documents pre-opinion review of product information for initial applications and annex-II applications

Adopted Reference Number: SOP/EMA/0009 Legal effective date: 15/12/2010

Work instructions for QRD forms 2 (former linguistic check forms)

Adopted Reference Number: WIN/EMA/0098 Legal effective date: 15/12/2010

Work Instructions for preparation of CxMP overviews of procedures requiring Member States linguistic review

Adopted Reference Number: WIN/EMA/0105 Legal effective date: 17/02/2010

Work Instructions for QRD co-ordination of post-opinion linguistic reviews of Initial Applications and Annex II applications

Adopted Reference Number: WIN/EMA/0106 Legal effective date: 17/02/2010

Work Instructions for new standard term requests to EDQM

Adopted Reference Number: WIN/EMA/0108 Legal effective date: 17/02/2010

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

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

Standard operating procedure for checking of mock-ups and specimens for new applications and extensions

Adopted Reference Number: SOP/H/3013 Legal effective date: 17/12/2010

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

Standard operating procedure for preparation of question-and-answer documents for withdrawals of marketing authorisation applications by the Medical Information Sector

Adopted Reference Number: SOP/H/3137 Legal effective date: 21/03/2012

Standard operating procedure for checking of mock-ups and specimens for renewals

Adopted Reference Number: SOP/H/3217 Legal effective date: 17/12/2010

Standard operating procedure for checking of mock-ups and specimens for transfer of marketing authorisation

Adopted Reference Number: SOP/H/3218 Legal effective date: 17/12/2010

Standard operating procedure for checking of mock-ups and specimens for all post-authorisation procedures other than new applications, line extensions, renewals and transfers

Adopted Reference Number: SOP/H/3219 Legal effective date: 17/12/2010

Work instructions for non-removal of the European public assessment report following withdrawal / expiry of the marketing authorisation

Adopted Reference Number: WIN/H/3202 Legal effective date: 12/09/2012

Work instructions for non-removal of the European public assessment report following suspension of the marketing authorisation

Adopted Reference Number: WIN/H/3216 Legal effective date: 12/09/2012

Work instructions for transparency of outcome of resubmission in previously published refusals or withdrawal European public assessment reports

Adopted Reference Number: WIN/H/3242 Legal effective date: 12/09/2012