Dáil Éireann Debate, Thursday - 14 February 2019
183. Deputy Catherine Martin asked the Minister for Health the ongoing supervision the Health Products Regulatory Authority carries out for parallel import products, particularly regarding repackaging; and if he will make a statement on the matter. [7583/19]
View answerA medicinal product, placed originally on the market in another EU Member State or EEA country, may be parallel imported to Ireland, provided that the equivalent product is already on the market here or has been withdrawn for commercial reasons only, and the importer has obtained a parallel import licence (known in Ireland as a parallel product authorisation (PPA)) from the HPRA to place the parallel imported product on the Irish market.
A PPA is granted only for a product that fulfils the following criteria:
- The Irish-market product must have a current, full Irish marketing authorisation at the time of submission or, if not still authorised, it must have been withdrawn for commercial reasons only.
- The parallel-imported product must have the same active substance(s), the same pharmaceutical form (e.g. tablet, capsule, injection, etc.) and have no significant therapeutic difference from, the Irish-market product.
- The parallel-imported product must be imported from an EU Member State or an EEA country and it must have a current, full marketing authorisation in that country.
As outlined above, the parallel import licence is termed a Parallel Product Authorisation and is identified by the letters ‘PPA’ in front of the authorisation number. Authorisation is granted under the Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended. Prior to placing the parallel imported product on the Irish market, a certain amount of over labelling or repackaging will be required under the terms of the PPA granted by the HPRA.
An additional requirement of obtaining an authorisation for a parallel product is that the repackaging and/or over labelling of the product is done in accordance with good manufacturing practice (GMP) by the holder of a manufacturer’s/importer’s authorisation (MIA). If the repackaging and/or over labelling takes place in Ireland, the MIA is granted by the HPRA (under the Medicinal Products (Control of Manufacture) Regulations 2007, as amended) if the manufacturing operation is found to be satisfactory on initial inspection. MIA holders are inspected for continuing compliance with GMP at regular intervals, generally every two to three years, under a risk based inspection programme.
I would refer the Deputy to the HPRA's website for a comprehensive guide to Parallel Imports of human medicines.
