Legislation first, then translation
Providing pharmaceutical PIL translations does not only concern 'being understood' in your target country. Legislation is at the forefront of our service.
All patient information leaflets are required to follow the order and include the content specified in article 59(1) of Council Directive 2001/83/EC On The Community Code Relating To Medicinal Products For Human Use and the particulars for labelling listed in Articles 54, 59 and 62 shall appear in an official language or official languages of the Member State where the medicinal product is placed on the market.
It is explicit in instructing applicants to ensure information design is considered along with the need for translation into all languages.
The Translation of Patient Information Leaflets (or ‘information leaflet’, ‘instruction leaflet’, ‘package insert’, ‘patient package insert’, or ‘consumer medicine information’), as well as the packaging and marketing materials, is a mandatory requirement when exporting pharmaceuticals products / medication.
Survey findings by the UK government’s Medicines & Healthcare Products Regulatory Agency tell us that patients value the PIL which comes with the medicine more highly than any other source of information except doctors and pharmacists.
Talking Heads approaches pharmaceutical legislative translation in a unique way - legislation first, then translation. This ensures that compliance is at the forefront of our service. Click here to read our Product / Labelling Translation Information.
Interpreters and translators with sector-specific knowledge and experience.
The utmost confidentiality upheld by all staff and linguists.
Fully inducted, reliable linguists at your disposal.