Centralised procedure

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Document(s) Language Status First published Last updated Effective Date
Work instructions for business analysis and forecasting manual, guidance for the business pipeline activity at the European Medicines Agency (English only) adopted 2017-02-27   2017-02-22
Standard operating procedure for eligibility to the centralised procedure for medicinal products for human use (English only) adopted 2016-02-10    
Work instructions for product-team-member allocation in the Regulatory Affairs Section for centrally authorised products (English only) adopted 2013-04-29   2013-04-26
Standard operating procedure for procedure for liaising between the European Medicines Agency, the Committee for Medicinal Products for Human Use (CHMP) and the Clinical Trials Facilitation Group on the potential CHMP negative opinion, pre-opinion or post-authorisation withdrawal, suspension or revocation of a marketing authorisation with impact on European Union clinical trials (English only) adopted 2012-03-01   2012-02-29
Standard operating procedure for evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products (English only) adopted 2012-03-01   2012-03-02
Standard operating procedure for handling of scheduled and urgent updates of regulatory and procedural guidance on EMA website (English only) adopted 2011-01-12   2011-01-12
Standard operating procedure on provision of regulatory advice: Handling of internal and external queries by the Regulatory Affairs Section (English only) adopted 2010-11-24   2010-11-23
Standard operating procedure for CHMP / CAT / PRAC rapporteur / co-rapporteur / peer-reviewer appointment in the centralised procedure (English only) adopted 2008-06-18 2017-04-11 2017-04-10
Standard operating procedure for rapporteur / co-rapporteur appointment for re-examination of a CHMP opinion (English only) adopted 2008-12-05 2012-09-26 2012-09-25
Standard operating procedure for handling and validation of EU-RMP annex 1 (English only) adopted 2009-07-01 2011-02-07 2011-02-04
Work instructions for EU-RMP annex 1: validation (English only) adopted 2009-07-01 2011-02-07 2011-02-04


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