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Like any technical translation, medical and pharmaceutical translations require a high level of linguistic skills, as well as a strong base of knowledge in terminologies and law. Thus, in a domain governed by the need for precision, patient information leaflet translators must meet a number of vitally important challenges.

Regulation of patient information leaflets

While trying to be made commercially available, health products are subjected to strict procedures.  A pharmaceutical company must produce for each medication a Marketing Authorization (MA) containing a Summary of Product Characteristics (SPC) and a Patient Information Leaflet (PIL) as well as the packaging and marketing materials. The data is then analysed and approved by the regulatory authority for the country where the product will be sold, i.e. The National Agency for the Safety of Medication and Healthcare Products (ANSM) in France or the European Medicines Agency (EMA) in Europe.

The Summary of Product Characteristics (SPC) is an indispensable document which presents all of the information of a medication in exhaustive detail. This document contains, among other things, the chemical composition, dosage, usage warnings, and the side effects. Once confirmed be the proper authorities, the SPC becomes the base from which the patient information leaflet is written.

Patient information leaflets, available for all

European pharmaceutical companies must provide their MA in the native language(s) of each member country in which they want their medication to be sold. On top of the 24 official languages, PIL translations may also be required for countries that are candidates for entry into the European Union or for recognized minority languages like Corsican or Catalan. Once translated, the AMs are sent within the delay established by the EMA to the Committee for Medicinal Products for Human Use (CHMP) for further validation.

In order to ensure the conformity of the translations, the patient information leaflets are tested for multilingual readability. The standards and norms vary depending on the culture and the location of the target country. Whenever an update occurs in relation to the information of a product, whether because of a change in legislation or some new discovery, a new translation must systematically be provided by the pharmaceutical laboratories.

Leaflets: requiring accuracy and precision

Within the medical domain, the smallest translation error can have enormous consequences, not only on the life of the patient, but also for the reputation of a health professional. Within pharmaceutical groups, every error in a leaflet translation can cause a delay in the commercial availability of a product, cause a product recall, or lead to legal proceedings. In order to avoid these risks, calling on translators specialized in the medical and pharmaceutical domains becomes a necessity.

In order to provide a medical translation that conforms to current directives, expert translators in European regulations and in the quality review of documents (QRD) work closely with pharmaceutical labs. With the necessary knowledge and skills, they ensure the validity of the information found within a pharmaceutical product’s leaflets.

*ANSM – The Agence Nationale de Sécurité du Médicament et des Produits de Santé
*PIL – Patient Information Leaflet
*QRD – Quality Review of Documents

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