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In brief

In a press release dated December 30, 2020, the AIFA (Agenzia Italiana del Farmaco) clarified that, in view of the current health emergency, applications for placing on the Italian market COVID-19 vaccines are subject to the emergency procedure for Batch Release provided for by the AIFA.

In light of this, the AIFA also pointed out that, in order to market vaccines, it will be necessary to obtain the prior authorization by the Product Quality and Pharmaceutical Crime Counteracting Office, thus excluding the application of the “positive silence” mechanism.

In addition, the AIFA indicated that the purpose of this procedure is to ensure compliance with checks set out in the Decree of the Ministry of Health dated March 31, 2008, and that the same procedure will be carried out in operational continuity, in order to allow the release of batches of vaccines, and therefore their availability, as soon as possible and in accordance with in-force regulations.

Lastly, the AIFA reminded that applicants must provide the AIFA with the following documentation:

  • Copy of the Batch Release Certificate, issued by the Official Medicines Control Laboratory (OMCL) of a Member State or of a Country with which mutual recognition agreements are in place;
  • Marketing Information Form, a form for the notification of the applicant’s intention to market a specific batch, in which all batch information (e.g., commercial name, batch number on secondary packaging, period of validity, expiry date, number of doses, etc.) is included; and
  • Batch Release procedure cover page, identifying the key batch data.

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.


Riccardo Ovidi is an associate in Baker McKenzie's Rome office.