Regulatory information - Revised dossier-submission requirements for active-substance master files

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14/08/2013

Regulatory information - Revised dossier-submission requirements for active-substance master files

The European Medicines Agency has updated its pre-authorisation procedural advice for users of the centralised procedure to reflect new requirements for the submission of active-substance-master-file (ASMF) dossiers as part of human or veterinary marketing-authorisation or variation applications. These new requirements will apply from 1 September 2013.

Until now, ASMF holders have been required to submit ASMF dossiers each time the ASMF was referenced in a new marketing-authorisation application or variation, even if the same ASMF had previously been submitted for an earlier procedure.

From 1 September 2013, ASMF holders will only need to submit their ASMF dossiers relating to a centrally authorised product to the Agency, and to the members of the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP) once.

The format of these submissions should be electronic common technical document (eCTD), non-eCTD electronic submission (NeeS) or veterinary NeeS (VNeeS).

According to the new ASMF submission rules, prior to submission, the Agency will assign a reference number on request. The 'EMEA' ASMF reference number (EMEA/ASMF/XXXXX) will ensure the appropriate data-lifecycle management of ASMFs used in one or more centralised marketing authorisations.

Marketing-authorisation holders share the responsibility with ASMF holders to ensure that ASMFs comply with submission requirements.

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