Product information

Work instructions for secretarial tasks for initial preparation and update of veterinary European public assessment reports (EPARs) (PDF/174.36 KB)

Adopted

First published: 07/05/2015
Last updated: 10/02/2016
Legal effective date: 08/02/2016
WIN/V/4035

Standard operating procedure for preparation of an initial European Public Assessment Report (EPAR) for a veterinary medicinal product following positive or negative opinion (PDF/132.87 KB)

Adopted

First published: 01/10/2007
Last updated: 17/06/2015
Legal effective date: 10/06/2015
SOP/V/4037

Standard operating procedure for certificates of medicinal products (PDF/101.8 KB)

Adopted

First published: 04/04/2012
Last updated: 04/04/2012
Legal effective date: 03/04/2012
SOP/INSP/2000

Work instructions for recording, validation and production of certificates of medicinal products (PDF/104.31 KB)

Adopted

First published: 04/04/2012
Last updated: 04/04/2012
Legal effective date: 03/04/2012
WIN/INSP/2029

Standard operating procedure for preparation, dissemination and publication of safety-related European Medicines Agency press releases and question-and-answer documents (PDF/280.57 KB)

Adopted

First published: 14/04/2011
Last updated: 14/04/2011
Legal effective date: 12/04/2011
SOP/EMA/0111

Work instructions for sending of lines to take and safety-related information to the European Union regulatory network and international partners (PDF/168.13 KB)

Adopted

First published: 14/04/2011
Last updated: 14/04/2011
Legal effective date: 12/04/2011
WIN/H/3210

Standard operating procedure for early notification system: procedure for advanced notification of emerging safety issues to European Union regulatory network and international partners (PDF/208.9 KB)

Adopted

First published: 14/04/2011
Last updated: 14/04/2011
Legal effective date: 13/04/2011
SOP/H/3346

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 (PDF/181.18 KB)

Adopted

First published: 14/04/2011
Last updated: 14/04/2011
Legal effective date: 13/04/2011
SOP/H/3347

Standard operating procedure for translation of product information for micro-, small- and medium-sized-enterprise applicants of the centralised procedure (PDF/128.37 KB)

Adopted

First published: 25/06/2010
Last updated: 25/06/2010
Legal effective date: 28/06/2010
SOP/EMA/0100

Standard operating procedure for Product Information Quality / Quality Review of Documents pre-opinion review of product information for initial applications and annex-II applications (PDF/100.78 KB)

Adopted

First published: 08/04/2009
Last updated: 15/12/2010
Legal effective date: 15/12/2010
SOP/EMA/0009

Standard operating procedure for Product Information Quality / Quality Review of Documents pre-opinion review of product information for renewal procedures (PDF/85.71 KB)

Adopted

First published: 30/04/2008
Last updated: 15/12/2010
Legal effective date: 15/12/2010
SOP/EMA/0046

Standard operating procedure for Quality Review of Documents post-opinion review of product information for initial applications and annex-II applications (PDF/101.42 KB)

Adopted

First published: 08/04/2009
Last updated: 15/12/2010
Legal effective date: 15/12/2010
SOP/EMEA/0047

Standard operating procedure for Quality Review of Documents post-opinion review of product information for post-authorisation procedures affecting the annexes, excluding annex-II applications (PDF/115.17 KB)

Adopted

First published: 08/04/2009
Last updated: 15/12/2010
Legal effective date: 15/12/2010
SOP/EMEA/0048

Work instructions for QRD forms 2 (former linguistic check forms) (PDF/78.22 KB)

Adopted

First published: 05/05/2009
Last updated: 15/12/2010
Legal effective date: 15/12/2010
WIN/EMA/0098

Work Instructions for preparation of CxMP overviews of procedures requiring Member States linguistic review (PDF/445.3 KB)

Adopted

First published: 18/02/2010
Last updated: 18/02/2010
Legal effective date: 17/02/2010
WIN/EMA/0105

Work Instructions for QRD co-ordination of post-opinion linguistic reviews of Initial Applications and Annex II applications (PDF/129.22 KB)

Adopted

First published: 18/02/2010
Last updated: 18/02/2010
Legal effective date: 17/02/2010
WIN/EMA/0106

Work Instructions for new standard term requests to EDQM (PDF/104.75 KB)

Adopted

First published: 18/02/2010
Last updated: 18/02/2010
Legal effective date: 17/02/2010
WIN/EMA/0108

Standard operating procedure for preparation of a European public assessment report for a human medicinal product following positive or negative opinion (PDF/121.26 KB)

Adopted

First published: 05/12/2007
Last updated: 13/09/2012
Legal effective date: 12/09/2012
SOP/H/3003

Standard Operating Procedure for updating of the European Public Assessment Report for a veterinary medicinal product (PDF/141.47 KB)

Adopted

First published: 01/10/2007
Last updated: 14/01/2016
Legal effective date: 18/12/2015
SOP/V/4038

Standard operating procedure for checking of mock-ups and specimens for new applications and extensions (PDF/108.9 KB)

Adopted

First published: 21/10/2008
Last updated: 20/12/2010
Legal effective date: 17/12/2010
SOP/H/3013

Standard operating procedure for handling of financial compensation for checking of product information by the Member States (PDF/96.74 KB)

Adopted

First published: 25/04/2008
Last updated: 20/12/2010
Legal effective date: 17/12/2010
SOP/H/3060

Standard operating procedure for preparation and updates of European public assessment report summaries by Product-related Information to the Network Service (PDF/260.73 KB)

Adopted

First published: 24/09/2010
Last updated: 14/05/2014
Legal effective date: 28/03/2014
SOP/H/3131

Standard operating procedure for preparation of question-and-answer documents for withdrawals of marketing authorisation applications by the Medical Information Sector (PDF/92.54 KB)

Adopted

First published: 28/11/2007
Last updated: 22/03/2012
Legal effective date: 21/03/2012
SOP/H/3137

Standard operating procedure for checking of mock-ups and specimens for renewals (PDF/94.06 KB)

Adopted

First published: 10/06/2008
Last updated: 20/12/2010
Legal effective date: 17/12/2010
SOP/H/3217

Standard operating procedure for checking of mock-ups and specimens for transfer of marketing authorisation (PDF/85.45 KB)

Adopted

First published: 10/06/2008
Last updated: 20/12/2010
Legal effective date: 17/12/2010
SOP/H/3218

Standard operating procedure for checking of mock-ups and specimens for all post-authorisation procedures other than new applications, line extensions, renewals and transfers (PDF/85.6 KB)

Adopted

First published: 10/06/2008
Last updated: 20/12/2010
Legal effective date: 17/12/2010
SOP/H/3219

Work instructions for non-removal of the European public assessment report following withdrawal / expiry of the marketing authorisation (PDF/111.46 KB)

Adopted

First published: 14/09/2007
Last updated: 13/09/2012
Legal effective date: 12/09/2012
WIN/H/3202

Work instructions for non-removal of the European public assessment report following suspension of the marketing authorisation (PDF/82.15 KB)

Adopted

First published: 01/07/2008
Last updated: 13/09/2012
Legal effective date: 12/09/2012
WIN/H/3216

Work instructions for transparency of outcome of resubmission in previously published refusals or withdrawal European public assessment reports (PDF/154.52 KB)

Adopted

First published: 18/06/2008
Last updated: 13/09/2012
Legal effective date: 12/09/2012
WIN/H/3242

Work instructions for secretarial tasks for initial preparation and update of veterinary European public assessment reports (EPARs) (PDF/174.36 KB)

Standard operating procedure for preparation of an initial European Public Assessment Report (EPAR) for a veterinary medicinal product following positive or negative opinion (PDF/132.87 KB)

Standard operating procedure for certificates of medicinal products (PDF/101.8 KB)

Work instructions for recording, validation and production of certificates of medicinal products (PDF/104.31 KB)

Standard operating procedure for preparation, dissemination and publication of safety-related European Medicines Agency press releases and question-and-answer documents (PDF/280.57 KB)

Work instructions for sending of lines to take and safety-related information to the European Union regulatory network and international partners (PDF/168.13 KB)

Standard operating procedure for early notification system: procedure for advanced notification of emerging safety issues to European Union regulatory network and international partners (PDF/208.9 KB)

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 (PDF/181.18 KB)

Standard operating procedure for translation of product information for micro-, small- and medium-sized-enterprise applicants of the centralised procedure (PDF/128.37 KB)

Standard operating procedure for Product Information Quality / Quality Review of Documents pre-opinion review of product information for initial applications and annex-II applications (PDF/100.78 KB)

Standard operating procedure for Product Information Quality / Quality Review of Documents pre-opinion review of product information for renewal procedures (PDF/85.71 KB)

Standard operating procedure for Quality Review of Documents post-opinion review of product information for initial applications and annex-II applications (PDF/101.42 KB)

Standard operating procedure for Quality Review of Documents post-opinion review of product information for post-authorisation procedures affecting the annexes, excluding annex-II applications (PDF/115.17 KB)

Work instructions for QRD forms 2 (former linguistic check forms) (PDF/78.22 KB)

Work Instructions for preparation of CxMP overviews of procedures requiring Member States linguistic review (PDF/445.3 KB)

Work Instructions for QRD co-ordination of post-opinion linguistic reviews of Initial Applications and Annex II applications (PDF/129.22 KB)

Work Instructions for new standard term requests to EDQM (PDF/104.75 KB)

Standard operating procedure for preparation of a European public assessment report for a human medicinal product following positive or negative opinion (PDF/121.26 KB)

Standard Operating Procedure for updating of the European Public Assessment Report for a veterinary medicinal product (PDF/141.47 KB)

Standard operating procedure for checking of mock-ups and specimens for new applications and extensions (PDF/108.9 KB)

Standard operating procedure for handling of financial compensation for checking of product information by the Member States (PDF/96.74 KB)

Standard operating procedure for preparation and updates of European public assessment report summaries by Product-related Information to the Network Service (PDF/260.73 KB)

Standard operating procedure for preparation of question-and-answer documents for withdrawals of marketing authorisation applications by the Medical Information Sector (PDF/92.54 KB)

Standard operating procedure for checking of mock-ups and specimens for renewals (PDF/94.06 KB)

Standard operating procedure for checking of mock-ups and specimens for transfer of marketing authorisation (PDF/85.45 KB)

Standard operating procedure for checking of mock-ups and specimens for all post-authorisation procedures other than new applications, line extensions, renewals and transfers (PDF/85.6 KB)

Work instructions for non-removal of the European public assessment report following withdrawal / expiry of the marketing authorisation (PDF/111.46 KB)

Work instructions for non-removal of the European public assessment report following suspension of the marketing authorisation (PDF/82.15 KB)

Work instructions for transparency of outcome of resubmission in previously published refusals or withdrawal European public assessment reports (PDF/154.52 KB)

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