Elisa Cappelli -

According to AIFA disposition n. 371 dated April 14th 2014, in the case of variations with impact on Package Information Leaflet (PIL) and/or labelling texts, AIFA allows the Marketing Authorization Holder to sell out the not updated stocks, on condition that the PIL/labelling texts are made available to pharmacists within 30 days from the publication of the variation approval in the Official Journal.

 

The changes, affecting the texts, that fall into the AIFA disposition, are the following:

 

  • restriction of therapeutic indication;
  • restrictive changes of posology;
  • addition of a new contraindication;
  • special warnings and precautions;
  • interactions with other medicines and other interactions;
  • use during pregnancy and breast-feeding;
  • addition of side effects and/or change of the frequency of the ones already described;
  • overdose;
  • restrictive change of storage conditions;
  • restrictive change of shelf-life after first opening

 

The obligations stated in the AIFA disposition are generally fulfilled through an electronic system for the collection and management of PIL/labelling texts.

Using this system, the updated version of the PIL and labelling texts is made available to the pharmacists, allowing them to provide the patients with the current version of the texts.

Consequently, following the approval of one of the above changes, the batches not including updated PIL/labelling can be maintained into the Italian market until the expiry date stated in the label.

Unless AIFA issues a different product-specific decision, this disposition avoids the recall from the Italian market of medicinal products with not updated texts.

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