Marketing authorisation templates
This page lists templates applicants may need for the preparation of their marketing authorisation application with the European Medicines Agency (EMA).
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Information required for identification of a need for pre-authorisation GCP inspections (DOC/110.5 KB)
First published: 13/02/2019
Last updated: 20/06/2022
Revision 1.4 -
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Information required for early identification of a need for pre-authorisation GMP inspections (DOC/73.5 KB)
First published: 22/06/2022 -
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Subject disposition for clinical study (DOC/45 KB)
First published: 11/12/2017
Last updated: 11/12/2017 -
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GCP inspections template (DOC/119.5 KB)
First published: 17/09/2015
Last updated: 17/09/2015 -
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GLP compliance: Non-clinical studies GLP compliance (annex to the cover letter) (DOC/118.5 KB)
First published: 17/09/2015
Last updated: 18/03/2022
Revision 1.1 -
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Request for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004' to be replaced by 'Briefing Note and Recommendations on a Request for Accelerated Assessment Pursuant to Article 14 (9) of Regulation (EC) No 726/2004 - Template (DOCX/150.43 KB)
First published: 03/11/2011
Last updated: 17/02/2021 -
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Letter of recommendations - Template (DOC/36.5 KB)
First published: 03/11/2011
Last updated: 19/03/2021 -
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Applicant’s consent to share assessment and inspection documents with non-European Union (EU) regulatory authorities template (DOC/135 KB)
First published: 30/03/2016
Last updated: 30/03/2016
EMA/801202/2015