Parallel-importation is the importation from an EU Member State or a country within the EEA of a medicinal product which is essentially similar to a product already authorised in Ireland, by an importer who is someone other than the importer appointed by the marketing authorisation holder of the product on the Irish market. The parallel trade of medicinal products is based on the principle of the free movement of goods within the internal market of the EU (articles 28-30 of the EC Treaty).
The framework under which HPRA grants authorisations for parallel-imported products is in line with that set out in the European Commission Communication on Parallel Imports of Proprietary Medicinal Products for which Marketing Authorisations have already been granted. Accordingly, HPRA operates a simplified scheme for authorisation of parallel-imported products, details of which can be found in our “Guide to Parallel Imports - Human Medicines
Once an authorisation is obtained from HPRA, the imported product may then be parallel-distributed in Ireland. A parallel product authorisation is identified by the letters 'PPA' in front of the authorisation number.
Where the product to be imported is identical in all respects (including identical packaging, labels and leaflets) to the product on the Irish market, the reduced requirements of the Dual Pack Registration (DPR) scheme apply; further details on this can be found in the Guide to Parallel Imports.
Please note that the parallel-distribution of medicinal products authorised by the European Commission (“centrally-authorised products”) should be notified to the EMA rather than HPRA. For more information, please consult the EMA Website.
Updates to Variation categories
The variation categories for PPAs were updated in March 2016 with consequential updates to the Guide to Parallel Imports - Human Medicines. A webinar was hosted by the HPRA and included two presentations - one on the changes to the variation categories and the Guide and an explanation on how to complete the new form and a second presentation on common errors and omissions in PPA applications.
Please see slides below and also a recording of the webinar for your information.
Updates to Variation Categories and Guide to parallel imports presentation
Parallel Imports - Common errors and omissions presentation
Recorded HPRA / PPA holder webinar