Parallel importation “The importation from an EU Member State, or an EEA country, of a medicinal product which is equivalent to one already authorised on the Irish market, by an importer who is someone other than the importer appointed by the marketing authorisation holder (MAH) of the product on the Irish market”.
Parallel distribution “The marketing of a centrally-authorised product, placed originally on the market in one Member State by the MAH, in any other part of the Community by a ‘parallel distributor’, independent of the MAH”.
This guide applies to nationally-authorised products which are parallel-imported from another EU Member State or another EEA country and distributed on the Irish market.
In order to legally place such a product on the Irish market a parallel import licence is required and the HPRA operates two schemes in this regard. Where the product to be imported differs in any respect from that on the Irish market, a parallel import licence (termed a ‘parallel product authorisation’) must be obtained.
Where the product to be imported is identical in all respects (including identical packaging, labels and leaflets) to the product on the Irish market, a parallel import licence (termed a Dual Pack import Registration (DPR)) is required.
The application forms mentioned in this guide are available on the ‘Publications and Forms’ section of www.hpra.ie.
Products that are centrally authorised by the European Commission are not covered by this guide.
Importers wishing to parallel distribute these products must notify the EMA of their intention. Details of the notification system are available on the EMA website.
Applicants are required to make all related documentation (including approval letters) received from the EMA available to the HPRA during an inspection.
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