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Italian Medicines Agency Agenzia Italiana del Farmaco

Procedure for submitting applications for marketing vaccines (State control for each batch) for COVID-19 - Procedure for submitting applications for marketing vaccines (State control for each batch) for COVID-19

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Procedure for submitting applications for marketing vaccines (State control for each batch) for COVID-19

Considering the ongoing emergency, only the "emergency procedure" for Batch Release provided for by AIFA should be followed for the applications for marketing vaccines for COVID-19 on the national territory.  Therefore, the procedure cannot be considered concluded with the silent consent mechanism but requires the release of an Authorisation by the Product Quality and Pharmaceutical Crime Counteracting Office. This modality, identified in order to guarantee the controls provided for in accordance with the provisions of the Decree of the Ministry of Health of 31 March 2008, is managed in operational continuity, allowing the release of batches of vaccines and therefore their availability in the shortest possible time and in compliance with the procedures in force.

The MAH requesting AIFA to place a batch of the CoVID-19 vaccine on the market is required to send - to the certified email address batch.release@pec.aifa.gov.it - the following documentation:

  • Copy of the Batch Release Certificate (CBR), a certificate issued by the OMCL of a Member State (including Italy) or of a State with which mutual recognition agreements are in place
  • Marketing Information Form (MIF), a form for the notification of the applicant's intention to market a specific batch containing all the information relating to the batch (e.g. commercial name, batch number on the secondary packaging, date of validity, expiry date, number of doses, etc.).
  • Batch Release procedure cover, where the main batch data are identified


Published on: 30 December 2020

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