Elisa Cappelli -

According to the definition reported in the Guidance on detection and notification of shortages of medicinal products for Marketing Authorisation Holders (MAHs) in the Union (EEA) adopted by HMA and EMA, the shortage of a medicinal product occurs when “supply does not meet demand at a national level”.

A medicinal product is considered in shortage when it is not available in the national territory and the MAH cannot temporarily guarantee a continuous and appropriate supply respect to the therapeutic need of patients, for example due to manufacturing issues or unexpected product requests increase.

The Italian Agency makes available on its official website the updated list of medicinal products facing a shortage situation and, following a case-by-case basis, can authorize the MAH to import the medicinal product from abroad or in case the specialty is difficult to retrieve, can authorize the health facilities that request the concerned medicinal product to import similar products. Moreover, the Agency can temporarily stop the export to limit the shortage.

Regarding shortage situations, temporary or definitive end of commercialization of medicinal products, AIFA recently published an informative note to provide indications to the MAHs on the modalities for the application of the dispositions foreseen by the Legislative Decree n. 219/2006, as modified by the so called “Decreto Calabria”, converted into the Law n. 60 dated June 25th 2019.

In particular, AIFA indicated:

• Responsibilities of MAHs
• Timing to be considered to inform the Italian Authority
• Mandatory information to be provided to AIFA
• Sanctions applied in case of non fulfillment of the requirements
• Criteria followed by AIFA in order to apply the sanctions

RPN is available to support MAHs in the fulfillment of the Law requirements.

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