Multilingual and multicountry packaging

Medicines availability is a major priority in the protection of public health. Companies can retain medicines on the Irish market by using multilingual packaging. This is the use of a joint pack with two or mare languages, which is shared between two or more markets. The HPRA is committed to working with companies to develop multilingual packaging, while remaining compliant with regulatory requirements to safeguard continued patient access to medicines. This page provides information on HPRA requirements for multilingual packaging and links on where to find further information.

A multilingual package must fulfil the following criteria:

• The name (i.e., invented name or common name + MAH) and the strength of the medicinal product is the same in all languages.
• The information is clearly presented on the labelling and package leaflet. This is so that patients can understand and use their medicines safely and appropriately.
• The information that appears on the labelling and the package leaflet is consistent with the information in the SmPC.
• The legal status (i.e., whether it is a prescription or non-prescription medicine) must be the same in all countries involved.

Guidance

MAHs are reminded of the CMDh Best Practice Guide on Multilingual Packaging which was published by the Co-ordination group for Mutual Recognition and Decentralised Procedures – Human (CMDh). This guide contains useful information for companies to follow when developing multilingual packaging. The HPRA Guide to labels and leaflets of human medicines includes further national guidance. This guide highlights areas where HPRA will be flexible to facilitate multilingual packaging (while working within Directive 2001/83/EC requirements).

Applying for multilingual packs

Applicants can request multilingual packaging during a new application procedure, or post authorisation using an Article 61(3) notification. To optimise a request, applicants should:

• Identify the member states where multilingual packs will be required early in the procedure.
• Provide sufficient justification for any flexibility they request for label information.
• Coordinate assessments across member states and share their comments so that assessments can be concluded in a similar timeframe.
• Request assistance if required from the HPRA in directly liaising with the other member states on behalf of the Marketing Authorisation Holder.

For further advice on the submission and design of multilingual labelling, including those authorised via the centralised procedure, please contact the HPRA’s Customer Services section at info@hpra.ie.

Joint packs with other member states 

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. We 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.