Medical Translation in Liège: CHU, IBA and Pharmaceutical Sector

Liège is home to one of the eight Belgian university hospitals, an active pharmaceutical cluster around the Sart Tilman and chemical companies such as Prayon whose products supply the global pharmaceutical industry. Medical translation in Liège is a daily challenge for the hospitals that transfer patients internationally, for the clinical research teams of the university hospital and for the manufacturers subject to the REACH and INAMI regulatory obligations.

A demanding medical and pharmaceutical ecosystem

The CHU de Liège is organised across three main sites: the Sart Tilman campus, the NDB site (Notre-Dame and Beau-Vallon merged) and the former Citadelle site, the latter now attached to the CHR de la Citadelle, an autonomous public hospital with its renowned ophthalmology and cardiology departments. To these two poles is added the Clinique Saint-Vincent in Rocourt, which notably welcomes French-speaking and allophone patients from the Liège outskirts.

The Liège basin is also a crossroads of diverse linguistic communities. The Moroccan and Algerian communities - among the largest in Wallonia - generate a sustained demand for medical translations into Maghreb dialectal Arabic and into modern standard Arabic. The Turkish community, historically rooted in the former mining and steel basins of the region, requires for its part medical documents translated into Turkish. These patients, often elderly, need prescriptions, surgical reports and informed consent forms in their mother tongue in order to give a truly informed consent.

On the industrial side, Prayon, world leader in phosphorus technologies based in Engis (Province of Liège), produces acid derivatives and phosphates used notably in the manufacture of pharmaceutical excipients. Its REACH obligations require the drafting and updating of safety data sheets (SDS) in all the languages of the marketing countries. The PharmaBiosciences cluster of the Sart Tilman moreover brings together university spin-offs active in biotech and in drug development that need precise regulatory translations for their Marketing Authorisation dossiers.

Types of medical and pharmaceutical documents translated in Liège

• Patient records for international transfer: hospitalisation reports, discharge letters, surgical reports and medical imaging for the patients of the CHU de Liège repatriated to Morocco, Algeria, Turkey or other countries
• Clinical research protocols (Phase I/II/III): translation of the clinical trial protocols of the CHU Liège into English, German or the EU languages, in line with regulation EU 536/2014 and the requirements of the ethics committees
• REACH safety data sheets (SDS): updating and translation of the 16-section SDS for Prayon and the actors of the Liège chemical industry, into French, Dutch, English, Spanish and the other EU languages
• INAMI reimbursement applications: translation and formatting of the dossiers submitted to the INAMI (National Institute for Health and Disability Insurance) for the admission to reimbursement of innovative medical devices and expensive medicines
• Medicine leaflets and SmPC: translation of the Summary of Product Characteristics (SmPC) and the patient leaflets according to the EMA QRD templates and the requirements of the AFMPS (Federal Agency for Medicines and Health Products)
• Multilingual informed consent forms: consent forms in Arabic and in Turkish for non-French-speaking patients admitted to the departments of the CHU, the CHR de la Citadelle and the Clinique Saint-Vincent

Regulatory framework: AFMPS, INAMI and REACH regulation

In Belgium, any translation of medical documents intended for use in a clinical or official regulatory framework must comply with strict standards. The AFMPSoversees the authorisation of medicines and medical devices on the Belgian market: its requirements regarding the translation of leaflets, SmPCs and labelling are directly aligned with those of the EMA for centralised procedures. Pharmaceutical translators must master MedDRA terminology for the coding of adverse effects and the QRD templates for the format of the leaflets.

The INAMI plays a central role in the reimbursement of Belgian healthcare. The reimbursement application dossiers for innovative medicines (article 81 procedure) and medical devices must be drafted in French or Dutch, depending on the applicable procedure. For the Liège actors who originally submit dossiers in English, a precise medical translation is indispensable. A terminological error in an INAMI dossier can delay reimbursement by several months and directly impact patients' access to innovative therapies.

For chemistry and industrial pharmacy, the REACH (EC No 1907/2006) regulation requires that the SDS sheets be available in the official language of the country of destination. Prayon, which exports its phosphates throughout Europe and beyond, must keep its SDS up to date in many languages. Our translators specialised in chemistry master the 16 mandatory sections and the CLP labelling standards.

Indicative timelines and rates for medical translations in Liège

These rates are given for indication. The final cost depends on the volume, the language pair, the degree of specialisation required and the urgency. For large-scale projects - complete clinical trial protocols, multi-document INAMI dossiers - we draw up a tailored quote after analysis of the source files. The rates are understood as VAT not applicable (exemption art. 44 §3 Belgian VAT Code).