Multilingual Nordic packages against availability problems
The Nordic region – five countries, 27 million inhabitants, five official languages. Multilingual Nordic packages are an important option for making medicines available in as many countries in the Nordic region as possible.
Availability of medicines is a hot topic across Europe; Brexit and the introduction of the medicines verification system will increase the challenges of ensuring availability of medicines. As regards marketing authorisations and packages, Nordic cooperation is increasingly becoming a necessity.
New, innovative medicines may be intended for conditions which affect such small numbers of patients in individual countries that bringing the product to market would not be cost-effective. Nordic packages could be the answer. Nordic packages often reduce the costs of pharmaceutical companies even with regard to medicines intended for larger patient groups. They also provide flexibility in the face of logistic and production-related challenges.
The Nordic regulatory authorities have gathered the guidelines for medicine packages in a single document, and also published a comprehensive questions and answers document. In addition, the procedure for common Nordic assessment of labelling texts introduced in 2014 is also working well. Common assessment by two or more Nordic countries makes it possible for marketing authorisation holders to receive the comments of all countries involved at the same time, with the authorities having already settled any conflicts between different countries.
An updated version of the Nordic package Q&A was published at the end of April. It was pleasing to note that all of the five countries in the Nordic region are able to agree on consistent guidelines for an increasing number of package-related issues.
At the Nordic Regulatory Affairs Meeting on Nordic multilingual packages, held in Stockholm at the beginning of May, it was explained that finding a common position has required a great degree of collaboration and discussion between the Nordic regulatory authorities over the past few years. It was also interesting to learn that because of the risk to medicines availability due to Brexit, Ireland has expressed an interest in joining Nordic packages. In modern society, English text on packages could actually be a useful addition.
Clear guidelines and practical assessment procedures are, and will continue to be, key in ensuring the availability of medicines. It is often possible to include several languages on a package, especially if the issue is addressed sufficiently early during the procedure. Nordic packages are an option worth considering – if you need help with planning and the overall procedure, we will be happy to help.