Marketing authorisation templates

This page lists templates applicants may need for the preparation of their marketing authorisation application with the European Medicines Agency (EMA).

Templates

Template for response to list of questions/list of outstanding issues: Quality / Non-clinical / Clinical

Information required for identification of a need for pre-authorisation GCP inspections

Reference Number: Revision 1.4

Information required for early identification of a need for pre-authorisation GMP inspections

Subject disposition for clinical study

GCP inspections template

GLP compliance: Non-clinical studies GLP compliance (annex to the cover letter)

Reference Number: Revision 1.1

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

Letter of recommendations - Template

Summary:

Template for the Cumulative Letter of Recommendations to be provided in MS Word format and as a signed PDF document. Please note that this letter should be updated on a cumulative basis as and when a new recommendation is added. If recommendations are fulfilled, this status can be indicated in the description.

Applicant’s consent to share assessment and inspection documents with non-European Union (EU) regulatory authorities template

Reference Number: EMA/801202/2015

Template for request of clock-stop extension