Italian Medicines Agency Agenzia Italiana del Farmaco

Change of classification for the supply of influenza vaccines to Medicinal products subject to medical prescription, renewable delivery (RR) - Change of classification for the supply of influenza vaccines to Medicinal products subject to medical prescription, renewable delivery (RR)

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Change of classification for the supply of influenza vaccines to Medicinal products subject to medical prescription, renewable delivery (RR)

The Scientific Technical advisory Committee (CTS) at the sitting of January 11, 12, 13, 14, 15 and 22, 2021 Minutes N. 38 (Centralized Procedures Office) and of May 5, 6, 7 and 13,  2021 Minutes N. 46 (Medicinal Products Authorisation Department) has decided to harmonise the classification for the supply of all packs of influenza vaccines by classifying them as “subject to medical prescription –renewable delivery (RR) –“ in order to allow for potential administration of all the pack-sizes also in a non-hospital setting.

The Marketing Authorization Holders of the influenza vaccines, subject to the change of the classification for supply referred to in the Determination of the Director General N. 792/2021 of July 5, 2021, should amend the labels of the presentations authorized in the national territory accordingly, within the anti-flu vaccination campaign of 2021/2022 or within the next vaccination campaign, in case packaging material reporting the previous supply classification (RRL/OSP), including the pharmaceutical sticker “bollino”used for traceability, has already been finalized.


Published on: 12 July 2021

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