Product information

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

AdoptedReference Number: WIN/V/4035Legal 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

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

Standard operating procedure for certificates of medicinal products

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

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

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

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

AdoptedReference Number: SOP/EMA/0111Legal 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

AdoptedReference Number: WIN/H/3210Legal 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

AdoptedReference Number: SOP/H/3346Legal 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

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

Standard operating procedure for translation of product information for micro-, small- and medium-sized-enterprise applicants of the centralised procedure

AdoptedReference Number: SOP/EMA/0100Legal effective date: 28/06/2010

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

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

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

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

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

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

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

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

Work Instructions for new standard term requests to EDQM

AdoptedReference Number: WIN/EMA/0108Legal 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

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

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

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

AdoptedReference Number: SOP/H/3013Legal 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

AdoptedReference Number: SOP/H/3131Legal 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

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

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

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

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

AdoptedReference Number: SOP/H/3218Legal 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

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

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

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

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

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

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

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