Nicolina Russo -

According to the Legislative Decree 219/2006 (art.38), any Marketing Authorisation of National/MRP/DCP medicinal products ceases to be valid:

  1. In case it is not followed by the actual placing of the medicinal product on the Italian market within three years after its granting
  2. In case an authorised medicinal product previously placed on the Italian market is not actually marketed for three consecutive years. The revocation date is calculated based on the available traceability data.

The Sunset Clause procedure is applied to the whole Marketing Authorization (MA). Therefore, until at least one presentation of the product is marketed and actually sold, the MA remains valid.

In order to enable the MAHs to plan any corrective action, AIFA periodically publishes the list of the MAs that are about to expire with at least two months of advance from the presumed Sunset Clause date.

Moreover, in exceptional circumstances (clearly described in the dedicated guideline), AIFA may grant Sunset Clause exemptions if the MAH submits the specific request to AIFA at least 30 days before the presumed Sunset Clause date. In order to submit the exemption request, the product must be included in the AIFA list and it has to meet at least one of the exemption criteria described in the dedicated guideline.

Regulatory Pharma Net offers full regulatory support throughout the whole drug lifecycle including any assistance or advice for exemption requests from the Sunset Clause.

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