The administrative burden of the marketing authorisation procedures for veterinary medicines has been estimated at 13 per cent of the sector's turnover – double that of the human medicines sector.
A third of this administrative burden concerns compliance with labelling rules. This really impacts the cost of packaging which in turn prevents the marketing of some products in smaller European countries.
The European commission's own impact assessment (1) reveals a dramatic difference between the number of veterinary medicines available to veterinarians in a large member state compared to a small member state.
Sometimes the 'cost of goods' can exceed the market value. A big factor in this is the cost of the labelling operation (the cost of the label itself is not the major hurdle).
Small markets only require small batches. What are needed are larger batches. What is needed is multi-lingual packaging.
Currently too much information is required on the labels of veterinary medicines. For small labels it is impossible to use multi-lingual labels and still fit all this information on it, without using difficult-to-read small font (which defeats the point of providing information).
The proposal for a regulation on veterinary medicinal products, which is currently in its first reading at the European parliament, has found a solution to this problem.
It involves reducing the amount of text on the 'immediate' label by adopting the principle that only information necessary to uniquely identify the bottle, for example, in your hand is necessary on the label.
All other information, such as instructions for use and safety warnings, can go on the outer packaging and the package leaflet.
When this approach is coupled with the use of certain standardised pictograms (e.g. the target animal species) and abbreviations (e.g. Lot and Exp.) it now becomes possible to have a label that requires little multiplication of the text to cover multiple languages.
In fact, it also brings added benefits, in that now the information on the label becomes much clearer and more accessible. It's a win: win.
However, there is still room for improvement in the legislative proposal – the proposed rules are unnecessarily restrictive.
Additional information that complies with the authorised information (i.e. the summary of product characteristics) should be allowed if there is enough space on the immediate and outer packaging of a product, especially when it involves larger packs.
There is also the issue of the need to have the phrase 'for animal treatment only' on the outer packaging.
This takes up so much space when translated that it works against the idea of using multilingual outer packaging.
The legislation will require all outer cartons to feature the intended animal species, and the idea is this will be in the form of a pictogram.
We have developed a set of species pictograms which have been accepted for use by the CMDv (coordination group for mutual recognition and decentralised procedures – veterinary).
In addition, there is usually artwork on the carton showing the medicine is for a particular animal species.
In short, it is obvious that it is a veterinary medicine, and the phrase 'for animal treatment only' is redundant. It needs to be removed or moved to the package leaflet.
A multilingual Europe needs a multilingual approach towards its packaging, especially if it is costing an industry sector such as the veterinary medicines one €184m in administrative burden.
(1) Figure 6, page 79 at http://ec.europa.eu/health/files/veterinary/vet_2014-09/impact_assessment_en.pdf