Post-authorisation

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Table of contents

Human

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Document(s) Language Status First published Last updated Effective Date
Standard operation procedure for handling of requests from a national competent authority to the CMDh for a recommendation on the classification of an unforeseen variation under Article 5 of Commission Regulation (EC) No 1234/2008 (English only) adopted 2013-03-14 2017-03-02 2017-03-01
Standard operating procedure for provision of scientific recommendation on classification of advanced-therapy medicinal products (English only) adopted 2011-11-07 2016-06-10 2011-11-07
Work instructions for handling of paediatric Article 45 work-sharing procedures by the Co-ordination Group for Mutual Recognition and Decentralised Procedure – Human (CMDh) secretariat (English only) adopted 2011-06-27 2014-03-21 2014-03-03
Work instructions for handling of paediatric Article 46 work-sharing procedures by the Co-ordination Group for Mutual Recognition and Decentralised Procedure – Human (CMDh) secretariat (English only) adopted 2011-06-27   2011-06-24
Standard Operating Procedure for marketing status reporting and sunset clause monitoring (Human Medicine) (English only) adopted 2008-04-25   2008-04-25

Veterinary

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Document(s) Language Status First published Last updated Effective Date
Work instructions for handling of renewals for centrally authorised veterinary medicinal products (English only) adopted 2016-07-20   2016-07-18
Standard operating procedure on annual re-assessment of centrally authorised veterinary medicinal products under exceptional circumstances (English only) adopted 2012-09-24 2016-05-13 2016-05-12
Standard operating procedure for processing of type II variations for medicinal products for veterinary use (English only) adopted 2008-05-16 2016-01-14 2015-12-10
Standard operating procedure for type IA variations (single and grouped) to centralised marketing authorisations (medicines for veterinary use) (English only) adopted 2008-05-16 2016-06-28 2016-06-24
Standard operating procedure for type IB variations to centralised marketing authorisations (medicines for veterinary use) (English only) adopted 2008-05-16 2016-05-13 2016-05-12
Work instructions for marketing status and sunset clause monitoring for centrally authorised veterinary medicinal products (English only) adopted 2017-05-12