PharmTech
CONTINUE TO SITE >

OR WAIT 15 SECS

European Union Local Language Requirements and How Labelling Systems May Provide a Solution

May 1, 2003
Bob Tilling

Pharmaceutical Technology Europe

Pharmaceutical Technology Europe, Pharmaceutical Technology Europe-05-01-2003, Volume 15, Issue 5

This article is intended to keep readers informed about the developments concerning the local language requirements for European Union member countries. The first part deals with the reasons why these language requirements are about to become more difficult to meet and the second part, based on recent application knowledge, offers some potential solutions.

Many labelling requirements are listed within the current European Union (EU) regulatory framework and are transposed across all of the member states. Individual member states may require labelling in their national language when a product reaches its final user, regardless of whether it is for professional or public use. And, member states may also authorize information to be in one or more additional European Community (EC) languages.

These local language requirements are not new; yet, the ever-increasing number of languages required on product labels, combined with customers' experiences of increased inspection activities in this area, have prompted a closer examination of the regulations. Concern is already being expressed regarding further language requirements as certain countries begin to enact similar legislation to the EU law to necessitate the use of their own national language. Such countries include Poland, Hungary and the Czech Republic, along with countries further afield in Asia.

Now, it is almost certain that Eastern European countries will enact similar legislation regarding the need for local language labelling because of the planned expansion of the EU (scheduled for 1 May 2004) from 15 to 25 members. The new countries are Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, the Slovak Republic and Slovenia. These countries, currently known as the 'acceding countries,' are all on schedule to meet the joining requirements. It is also expected that Bulgaria and Romania will join the EU in 2007. Part of the requirement for expanded membership is for each country to adopt the common rules, standards and policies that make up the body of the EU law. Once again, it is almost certain that the new EU countries will adopt the local language requirements. In fact, as previously mentioned, some countries are already looking at implementing such legislation.

Mergers and acquisitions

A more surprising requirement for the need to move towards more local language labelling is the seemingly never-ending acquisition of smaller pharmaceutical manufacturing companies by the large multinationals. Such takeovers dramatically increase the potential market for smaller manufacturers as they can suddenly take advantage of the well-established distribution channels that the multinational companies benefit from. This opens up markets in countries that had not previously been considered, leading to an increased need for the provision of local language labelling. Several recent labelling projects have been expanded at the last moment to provide a printing facility at an additional site. This is usually as a result of the purchase of a new subsidiary and the desire to get its products through the distribution channel of the parent company.

One further reason for the increase in requests for local language solutions is the occasional merging of multinational pharmaceutical companies. The recent merger between Pfizer and Pharmacia is a good example and is typical of several other important mergers during the last 18 months. Experience has shown that such mergers usually lead to the increased distribution of each company's products and hence the need for more local language labelling. This requirement is often combined with the need to change such items as the manufacturer's contact address on the label, thus producing another reason for labelling process changes.

There are two other requirements that are often addressed as part of the scope of supply for a local language labelling system. Typically, they are Conformit矅urop蠮 (CE) marking for EU distribution, and for markets such as the US, the Code of Federal Regulations must be applied to any product labelling. Further complications can involve Instructions for Use booklets and other customer specific requirements such as barcoding or branding. All this and more would need to be accommodated in each of the European languages. There may not be 25 completely different languages in the expanded EU, as some countries do share a common tongue, but there will be more than 25 combinations of languages required. Although it is possible to handle the barcoding and branding elements within a labelling system, experience has shown that it is best to handle the Instructions for Use requirements outside the scope of the labelling system.

Possible solutions

Having explained the reasons for the local language requirement expanding and presenting a new challenge to pharmaceutical manufacturers, we can explore some of the possible solutions and the potential impact upon production. Traditionally, one approach has been to use the innovations in booklet labels to contain all the languages required in a single multilayered label. This approach has worked well to date, because such booklet labels just about manage with the 15 EU member languages. It is unlikely, however, that booklet labels can be produced with 25 languages and still fit through a thermal transfer printer for the addition of batch-specific information such as lot number and expiry details. It is, of course, possible to add batch-specific information directly to the product as a separate operation via an inkjet coder, for example. Even if the batch coding problem is solved by other means, the booklet label may become unmanageable for small products or products in irregularly shaped containers.

Another potential solution is to use a dedicated single language label for each country. Assuming the ultimate destination of the product is known, label sizes can be kept to a minimum and, thus, control parallel importing. If the number of products and country variants is large, this will make the process more complex, more prone to error and will almost certainly have an impact on inventory. Can the label be truly single language? It may be necessary to label products with the originator's language for ease of recognition during production and distribution, as well as the destination market language. There may also be cases when the market has a requirement for multiple languages, such as Belgium and Switzerland. The option may then be to break down requirements on a regional basis and develop label solutions with languages for countries in, for example, Scandinavia (Norwegian, Swedish, Finnish, Danish) or Southern Europe (Portuguese, Spanish, Italian and Greek). This solution may keep variants and cost to a minimum, but has similar limitations to the single language option. Some stock products will be excluded from some countries because they do not carry the correct language for that particular country.

Languages

Labelling products with all language requirements will offer the greatest flexibility but may in itself create other problems. This is unlikely to be a suitable solution for small products where there is limited space or the labelling requirements increase the pack size. Some packages may become physically unmanageable and may conflict with environmental design and minimum adequate packaging. As no single solution for accommodating the language requirements is ideal for all circumstances, a combination approach is usually adopted.

To use a combination approach, it helps if the final destination of the product being labelled is known. If this destination is known at the time of labelling, during the product production process, then it is not too difficult to retrieve the destination country from the enterprise resource planning (ERP) system and print a label with the relevant language. If the product destination is unknown, then this approach becomes unusable and another option must be considered. All the current EU languages could be included on one label if it was large enough; however, this approach would have to be revised in 2004 when the EU expands to 25 countries because it is unlikely that any label would be large enough to contain all the required languages.

In the author's experience, a good approach is to print the six most popular EU languages for a given product on a label that, if possible, is smaller than actually required - thus leaving room for a supplementary label. This allows the product to be shipped directly to any one of its six most important EU markets without any additional labelling. This approach allows products to be held in stock for the six designated countries. Combining this with a country-specific labelling system in the despatch area can provide a major step forward in the solving the local language requirement issues.

Country-specific labelling systems work by an operator scanning a product that is being picked for despatch and the labelling system checking the relevant product code. The central label database is checked to see exactly which six languages are already contained on the product label; this is then compared with the languages required by the destination country as dictated by the job data contained in the ERP system. If all the required languages exist, then the operator is informed and the product is ready for despatch. If not, then a message informs the operator that a supplementary label is required. The supplementary label is automatically printed and the operator places it alongside the existing product label. To ensure high levels of accuracy, the labelling software can eliminate the need for any additional operator input and produces labels on demand. If possible, all label designs should be printed on the same paper stock; thus, only one printer is required at each print station and label stock errors are reduced. If one size of label stock is not appropriate (for example, three different sizes may be required), then the accuracy can be maintained by using three printers to action a single print request. This provides the operator with the correct quantity of different labels, (box label, carton label and pallet label), without the need for numerous inputs and printer or label stock changes.

The database

The power and intelligence behind a country-specific labelling system is a database containing local language tables; a table being created for each language required. Each local language word or phrase should be cross-referenced to the equivalent word or phrase in the originator's language. This removes the need for label designers or print operators to be familiar with the foreign language being used, which is important to avoid errors in translations. The local language database should be security protected, contain a history log and, of course, be included in the overall validation of the labelling system.

Such automated labelling systems must be validated for use within pharmaceutical manufacturing plants. The validation needs to concentrate on the database tables and the automation of the language selection process. Most customers expect the software supplier to help with this work; they prefer to select a supplier with pharmaceutical or medical industry experience. The content of the database tables is verified and approved, thus changing or redesigning labels does not involve a large amount of revalidation. Testing is done to ensure that entering the correct product code calls up the correct format, and it contains the appropriate language elements from the database.

Translations. Other than the need for any labelling system to operate to documented procedures and be completely validated to an approved protocol, the greatest labelling issue arises in the documentation or creation of translations. Translations are a potential area for errors, either during translation or during design and printing because checking and inspection is difficult if personnel are not familiar with the language.

The choice of translator is, therefore, extremely important to ensure that translations are accurate, consistent and technically correct. Because it may be difficult to find suitably experienced translators, a verification step within the procedure is a good idea. If possible, translations should be sent to an expert in the country concerned who has suitable product knowledge and language skills to determine if the translation is acceptable. Once again, experience has demonstrated not to underestimate the time, organization and cost involved in setting up and running such a translation verification system. This combined approach goes a long way towards matching the requirements of producing products in bulk for stock and ensuring the products are labelled with the correct local language before despatch. Although some stock is labelled twice, the nature of the application now makes this unavoidable.

In combination with any of the above approaches, every effort should be made to ensure the efficient use of space on labels. Consideration should be given to the use of appropriate graphics or symbols, as they take up less space and do not require translation. It is possible, however, that some potential product users may not recognize the symbols, so they should also be defined - in all languages - within the Instruction for Use leaflet. The instructions should be written in all the EU languages because this allows additional labelling on the exterior of the package without the need to open any product boxes. Label space constraints have led to a greater reliance on the content of Instructions for Use; however, care must be taken to prevent the leaflet becoming a multipage booklet.

Conclusions

Experience has shown that with a little planning, labelling systems can assist with the soon-to-be-expanded local language requirements of the EU. It will be even more difficult for innovations such as booklet labels to cope with the increased number of languages. With the use of labelling systems, the process can be automated to produce the correct language or to print the most common languages if the destination is unknown at the time of production. Further enhancement can provide enough intelligence in the labelling system to decide if a supplementary label is required for a particular product to a destination when it is picked for despatch.

For many pharmaceutical manufacturers, it could mean additional production steps are required to meet the labelling requirements. But, as a final word of caution, the planning and implementation of such solutions can take a lot longer than some people estimate.