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Pre-submission meetings

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Publication date: February 25, 2014

Spanish version

Centralized procedure 

Medicinal products for which a marketing authorization application or a proposal for variation to the terms of the marketing authorisation will be submitted through the centralized procedure and for which a Spanish member of the Committee for Medicinal Products for Human Use (CHMP) had already been appointed as Rapporteur or Co-Rapporteur. The instructions to be followed are detailed in the following document: AEMPS Pre-Submission Guidance for Users of the Centralised Procedure

Meeting Request Form: spanish, english version.

Decentralised or mutual recognition procedure

Medicinal products for which a marketing authorization application or a proposal for variation to the terms of the marketing authorisation will be submitted through decentralised or mutual recognition procedure and for which the AEMPS is or has been appointed as Reference Member State (RMS).

These presubmission meetings will be organized at the request of the AEMPS or the Company (after agreement with the AEMPS).  Payment of fees is not required for this type of meeting.

The procedure for requesting these meetings as well as the procedure, timelines and documentation needed are the same to those applicable for scientific advice.

Others

Medicinal products for which a marketing authorization application will be submitted through national, decentralised, mutual recognition or centralised procedure and for which there is not already appointed RMS or Rapporteur/Co-Rapporteur, as applicable. In these cases the procedure should be in line with the requirements and timelines described in the section for scientific advice.