Product information

  • Email
  • Help

Back to top

Document(s) Language Status First published Last updated Effective Date
Work instructions for secretarial tasks for initial preparation and update of veterinary European public assessment reports (EPARs) (English only) adopted 2015-05-07 2016-02-10 2016-02-08
Standard operating procedure for preparation of an initial European Public Assessment Report (EPAR) for a veterinary medicinal product following positive or negative opinion (English only) adopted 2007-10-01 2015-06-17 2015-06-10
Standard operating procedure for certificates of medicinal products (English only) adopted 2012-04-04   2012-04-03
Work instructions for recording, validation and production of certificates of medicinal products (English only) adopted 2012-04-04   2012-04-03
Standard operating procedure for preparation, dissemination and publication of safety-related European Medicines Agency press releases and question-and-answer documents (English only) adopted 2011-04-14   2011-04-12
Work instructions for sending of lines to take and safety-related information to the European Union regulatory network and international partners (English only) adopted 2011-04-14   2011-04-12
Standard operating procedure for early notification system: procedure for advanced notification of emerging safety issues to European Union regulatory network and international partners (English only) adopted 2011-04-14   2011-04-13
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 (English only) adopted 2011-04-14   2011-04-13
Standard operating procedure for translation of product information for micro-, small- and medium-sized-enterprise applicants of the centralised procedure (English only) adopted 2010-06-25   2010-06-28
Standard operating procedure for Product Information Quality / Quality Review of Documents pre-opinion review of product information for initial applications and annex-II applications (English only) adopted 2009-04-08 2010-12-15 2010-12-15
Standard operating procedure for Product Information Quality / Quality Review of Documents pre-opinion review of product information for renewal procedures (English only) adopted 2008-04-30 2010-12-15 2010-12-15
Standard operating procedure for Quality Review of Documents post-opinion review of product information for initial applications and annex-II applications (English only) adopted 2009-04-08 2010-12-15 2010-12-15
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 (English only) adopted 2009-04-08 2010-12-15 2010-12-15
Standard operating procedure for Product Information Quality/Quality Review of Documents pre-opinion review of product information for referral procedures and Article 29 paediatric procedures (English only) adopted 2009-04-08 2011-08-24 2009-04-08
Work instructions for QRD forms 2 (former linguistic check forms) (English only) adopted 2009-05-05 2010-12-15 2010-12-15
Work Instructions for preparation of CxMP overviews of procedures requiring Member States linguistic review (English only) adopted 2010-02-18   2010-02-17
Work Instructions for QRD co-ordination of post-opinion linguistic reviews of Initial Applications and Annex II applications (English only) adopted 2010-02-18   2010-02-17
Work Instructions for new standard term requests to EDQM (English only) adopted 2010-02-18   2010-02-17
Standard operating procedure for preparation of a European public assessment report for a human medicinal product following positive or negative opinion (English only) adopted 2007-12-05 2012-09-13 2012-09-12
Standard Operating Procedure for updating of the European Public Assessment Report for a veterinary medicinal product (English only) adopted 2007-10-01 2016-01-14 2015-12-18
Standard operating procedure for checking of mock-ups and specimens for new applications and extensions (English only) adopted 2008-10-21 2010-12-20 2010-12-17
Standard operating procedure for handling of financial compensation for checking of product information by the Member States (English only) adopted 2008-04-25 2010-12-20 2010-12-17
Standard operating procedure for preparation and updates of European public assessment report summaries by Product-related Information to the Network Service (English only) adopted 2010-09-24 2014-05-14 2014-03-28
Standard operating procedure for preparation of question-and-answer documents for withdrawals of marketing authorisation applications by the Medical Information Sector (English only) adopted 2007-11-28 2012-03-22 2012-03-21
Standard operating procedure for checking of mock-ups and specimens for renewals (English only) adopted 2008-06-10 2010-12-20 2010-12-17
Standard operating procedure for checking of mock-ups and specimens for transfer of marketing authorisation (English only) adopted 2008-06-10 2010-12-20 2010-12-17
Standard operating procedure for checking of mock-ups and specimens for all post-authorisation procedures other than new applications, line extensions, renewals and transfers (English only) adopted 2008-06-10 2010-12-20 2010-12-17
Work instructions for non-removal of the European public assessment report following withdrawal / expiry of the marketing authorisation (English only) adopted 2007-09-14 2012-09-13 2012-09-12
Work instructions for non-removal of the European public assessment report following suspension of the marketing authorisation (English only) adopted 2008-07-01 2012-09-13 2012-09-12
Work instructions for transparency of outcome of resubmission in previously published refusals or withdrawal European public assessment reports (English only) adopted 2008-06-18 2012-09-13 2012-09-12