Medicines regulators in the Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) have recently launched the Nordic Packaging pilot which will run until 2030. The pilot will investigate the provision of packs containing English-only labelling and the package leaflet printed in English for low volume hospital administered products.
Adding Irish product details to such packs could help maximise the availability of medicines in Ireland.
- MAHs can avail of this in cases where:
- the product information text is fully harmonised, for example through MRP/DCP
- no additional Irish blue box elements are required
- MAHs can then submit a national article 61.3 notification to add required authorisation details such the as marketing authorisation holder and PA number to such packs.
- This will result in a joint pack and further flexibility for companies.
- The HPRA can also support this approach for centralised products, however reviews of centralised mock-ups are within the remit of the EMA.
- This approach further complements the existing multilingual packaging initiatives as highlighted in the CMDh Best Practice Guide on Multilingual Packaging.
Source: HPRA