The HPRA views the management of medicines availability as a major priority in the protection of public health. The use of multilingual packaging can be key to companies retaining medicines on the Irish market. The HPRA is therefore committed to working with companies to develop multilingual packaging while remaining compliant with regulatory requirements to safeguard continued patient access.
A multilingual package must fulfil the following criteria:
- The name (i.e. invented name or common name + MAH, as applicable) and the strength of the medicinal product is the same in all languages.
- The information in the SmPC is consistent with the information that appears on the labelling and the package leaflet.
- The information is clearly presented on the labelling and package leaflet so that it can be understood by those who see it and patients can use their medicines safely and appropriately.
- The legal status (i.e. whether it is a prescription or non-prescription medicine) must be the same in all countries involved.
The HPRA has worked with the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) to draw up the CMDh Best Practice Guide on Multilingual Packaging. This contains useful principles for companies to follow when developing multilingual packaging.
Following on from this, to facilitate the use of multilingual packaging, the HPRA ‘Guide to labels and leaflets of Human Medicines’ was updated in December 2019 to include further national guidance. This highlights areas where the HPRA will be flexible in order to facilitate multilingual packaging (while working within Directive 2001/83/EC requirements). This is to demonstrate the HPRA’s desire to facilitate multilingual packaging and to recognise the difficulties in developing such packaging with two or more languages. The updated Guide is available on the HPRA website and should be consulted when developing multilingual packaging.
Applicants can optimise multilingual packaging requests by identifying early in procedures those member states where multilingual packs will be required, providing sufficient justification for any flexibility requested, coordinating assessments across the relevant member states and by sharing their comments so that assessments can be concluded in a similar timeframe. If necessary, the HPRA can also assist in directly liaising with the other member states on behalf of the Marketing Authorisation Holder if the other member states are agreeable to this.
The HPRA would also like to remind Marketing Authorisation Holders that dual labelling for human products, whereby a single approved label includes both the Irish and UK particulars will continue to be acceptable for the Irish Market.
For further advice on the design of multilingual labelling, including those authorised via the centralised procedure, please contact the HPRA’s Customer Services section at firstname.lastname@example.org.