Irelands Health Products Regulatory Authority (HPRA) released guidance on "Guide to Parallel Imports of Human Medicines" last week (12 July, 2023), which applies to nationally-authorized products which are parallel-imported from another EU Member State or another EEA country and distributed on the Irish market.
Parallel Imports is the importation of a medicinal product that is equivalent to one already authorised on the Irish market from an EU Member State, or an EEA country, by an importer who is someone other than the importer appointed by the marketing authorisation holder (MAH) of the product on the Irish market.
To legally introduce a product into the Irish market, an appropriate parallel import license is necessary.
The guidelines mention that 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’ (PPA)) 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.
A PPA is granted only for a product that fulfils the following criteria
The Irish-market product must have valid marketing authorization or have been withdrawn for commercial reasons.
The parallel-imported product must have the same active substance, and pharmaceutical form, and be therapeutically equivalent to the Irish-market product.
The parallel-imported product must be imported from an EU Member State or an EEA country with a valid marketing authorization.
The parallel importer must demonstrate how any additional risk minimization measures will be implemented for the parallel-imported product, coordinating with the Irish market MAH and/or the HPRA if necessary.
The parallel importer must also keep informed of any relevant change in the parallel-imported product in order to ensure that the PPA document reflects the current situation at all times. The guidance states that all variations must be approved by the HPRA prior to implementation by the parallel importer and the initial PPA remains in force either indefinitely or for a maximum of five years.