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AIFA clarifies variations and renewals for parallel importation

The Italian Medicine Agency clarified the modalities for the submission of variations and renewals of parallel importation medicine authorisations. These are further instructions to follow for the submission and any required integration of renewal applications submitted as of 1st January 2019.

In particular, the modalities are clarified for the submission of the variations occurred for the imported product and the Italian reference product at the date of submission of the renewal application.

Together with renewal application (to be submitted according to the AIFA guidelines), the parallel importer shall submit the separate variations for each type of change occurred, providing in the renewal application any information required on an missing communication of one or more variations in the reference period preceding the renewal application.

If a parallel importation medicine has never been marketed, then a selfcertification by the importer will be sufficient, stating that the medicine was never marketed and including a commitment to submit the variations before the communication of first marketing to AIFA.

The Agency also reminded the obligation of the parallel importation authorisation holder to submit the variations occurred following the release of the parallel importation authorisation for the product affecting safety no later than 30 days from the publication of the approved changes of the Italian reference product in the Official Journal.

Late submissions of any kind of variation can be accepted only if adequately justified: in case of safety variations, no batch of product shall be present in the distribution channel at the moment of the late submission of the variation.

Foto di Arek Socha da Pixabay