Authorisation and first controls by AIFA (the Italian Medicine Agency)
The parallel import procedure is currently regulated by the (Italian) Ministerial Decree of 29 August 1997. A parallel imported medicinal product is subject to an authorisation released by the (Italian) Evaluation Office and the AIFA, provided that the imported product has been granted a marketing authorisation in the member state of origin and the imported product is essentially “comparable” to a product that has already received marketing authorisation in the member state of destination.
Approval of the holder of an (Italian) marketing authorisation (AIC) and further controls
Based on the cooperation principle of the member states, AIFA acquires the “technical sheet” of the imported drug from the exporting country in order to verify the sameness or superimposability of the product marketed abroad with the one registered in Italy. Then follows the post-authorisation, that is the phase that goes from the advertising of the authorisation of the Determination to the placing on the market of the imported drug.
Per commercializare un prodotto di distribuzione europea, l’importatore parallelo To market a European distribution product, the parallel importer must reprocess it and follow specific regulations in the country of destination. This reprocessing can be carried out in two ways: adding labels to the original package or repackaging. In any case, this operation is carried out by a packaging company that is certified at a European and national level ricondizionarlo e seguire determinate norme in materia nel paese di destinazione.
Operators involved in the pharmaceutical distribution circuit of the imported specialty must be authorised as logistical sites for human use medicines distribution on the national territory (article 100 of (Italian) Legislative Decree 219/2006, formerly Legislative Decree 538/92). D.Lgs. 219/2006, formerly Legislative Decree 538/92).
These products are not generics but rather medicinal specialties with regular marketing authorisation that offer real economic benefits to the pharmacy. Consequently, the pharmacist can dispense the imported medicine in a classical and routine way, optimizing its profit.
Imported products enjoy the same supply and reimbursement classification as the "originator" specialties already on the Italian market for any range (A, C, SOP-OTC) published in the (Italian) Official Gazette.