The Health Products Regulatory Authority (HPRA) updated its guidance on "Parallel Imports of Human Medicine" last week.
Parallel importation is "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".
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 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 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.
Products which are centrally-authorised by the European Commission are not covered by this guide. A PPA is granted either for unlimited validity or, if deemed necessary for pharmacovigilance reasons, for a maximum period of five years, at which time the authorisation must be renewed. After the renewal, the PPA remains valid indefinitely.
Click this LINK for more detailed information on Parallel Imports of Human Medicines
Comments