Language barriers should not prevent people from having access to accurate information about medicines. The most important document regarding the purpose and characteristics of a drug is the Summary of Product Characteristics (SmPC).
The SmPC is a full, official description of a pharmaceutical product, which lists the active substance, its composition, uses, dosages, pharmaceutical forms and known adverse reactions.
It explains how medical professionals can use and prescribe the medicinal product safely and effectively. SmPCs are written and updated by the Regulatory Affairs Departments of pharmaceutical companies.
The SmPC is used as the basis for the Patient Information Leaflet (PIL). It is inserted into the drug pack, and includes information about how non-professionals can use the medicine safely and correctly.
For European Community countries, on top of the requirements of the country’s own drug regulatory authority, pharmaceutical companies also have to meet the requirements of the European Medicines Agency (EMEA).
EMEA and the various national medicine evaluation agencies require that the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and the packaging and labelling texts be presented in the official language or languages of the Member States in which the medicinal product is marketed.
Language translation and localisation challenges
24 official EU languages
Pharmaceutical companies manufacturing in the European Union need to make the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and the packaging and labelling texts available in up to the 24 official languages of the European Union.
Languages of the European Economic Area, new EU candidate countries
Additional languages are those countries which are non-EU but EEA members (Norway and Iceland), candidate EU countries (Serbia and Macedonia).
20 days to produce translations
EMEA sets a strict time frame of 20 days for translated versions of all documents to be submitted.
Updates to product information can result from changes in legislation or product changes through new discoveries and generally take place a couple of times per year.
Consequences of mistranslations
As regards specifications, usage, dosage and side effects, incompetent translations and mistranslations can lead to serious consequences.
How to determine whether a pharmaceutical translation provider is an expert in SmPC, PIL, and drug labelling language services
- Ability to structure SmPCs, PILs and drug labels in all EU languages in accordance with the directives and guidelines of good practice and requirements of BfArM, EMEA, MedDRA and EDQM standard terms.
- A large team of medical translators who are experts in European regulatory submission and have experience with the latest Quality Review of Documents Groups (QRD) Templates.
- Usage of a coherent content management strategy – area-specific dictionaries and glossaries.
- Providing accurate localisation and language adaptation of SmPCs or PILs in accordance with specific project requirements and official legislation requirements.