Summary of product characteristics
The text for healthcare professionals, organised in a prescribed sequence of sections and containing information that must remain consistent wherever it appears – from composition to adverse reactions.
Medicinal products · English–German
German product information is submitted, assessed and approved as written.
Summaries of product characteristics (SmPC), package leaflets, labelling and the marketing authorisation documents that relate to them – translated from English into German, and handled by me personally.
Most specialist translation sits alongside the original. Product information does not: the German wording is the text under assessment. Healthcare professionals work from the SmPC and patients from the package leaflet, and what the competent authority approves is particular wording – not an approximate meaning.
Pairs of defined terms
Adverse event and adverse reaction are not interchangeable
Medicines terminology relies on pairs of terms that differ in one respect only: whether a causal link to the product is in question. Using the same German term for both can shift the meaning in either direction: an event with no necessary causal link becomes an adverse reaction, or the causal implication of a reaction is lost when it is rendered as an event.
The examples on this page were created solely for illustration. None contains client material or reproduces the unedited output of a particular translation system.
English source text
An adverse event is recorded regardless of causality; only an adverse reaction belongs in section 4.8.
Error type: one word for two terms
„Eine Nebenwirkung wird unabhängig vom Kausalzusammenhang erfasst; nur eine Nebenwirkung gehört in Abschnitt 4.8.“
The German sentence now contradicts itself
Reviewed translation
„Ein unerwünschtes Ereignis wird unabhängig vom Kausalzusammenhang erfasst; nur eine Nebenwirkung gehört in Abschnitt 4.8.“
Both terms remain distinguishableSection 4.8 of the SmPC is headed Nebenwirkungen in German – adverse reactions. It covers those for which a causal relationship with the product is at least a reasonable possibility; an adverse event does not qualify merely because it occurred. The choice of term therefore determines what belongs in the section.
The same applies to strength and dose, to the distinction between a contraindication and a warning, and to the frequency categories from “very common” to “not known”. Their boundaries are defined, and their names must not be paraphrased. None of these distinctions is apparent from grammar alone: a defined term must first be recognised as such.
The standards-related requirements and steps I cover are explained on the home page under Two standards, a clearly defined scope.
Document family
Authorisation and product information
This family is the core of the pharmaceutical service: the summary of product characteristics, the package leaflet, labelling and the related documents from authorisation and variation procedures.
Package leaflet
The patient-facing version, derived from the SmPC and consistent with it. Making it accessible without shifting the approved meaning is where the work lies.
Labelling
Text for the outer packaging and immediate packaging. Space is limited, wording is prescribed, and there is no room for competing formulations of the same information.
Marketing authorisation documents
Documentation from the marketing-authorisation procedure and subsequent variations, in which the proposed product information is substantiated and checked for consistency with the rest of the dossier.
How I work
Five checks for product information
- Establish who the document is for – healthcare professionals or patients. Everything else follows from that.
- Adopt prescribed standard wording and the section structure instead of rewriting them.
- Keep defined pairs of terms apart, above all where the only difference between them is causality.
- Check strengths, quantities, units and frequency categories one by one against the source.
- Read the finished document in one pass, because the same statement recurs in several places.
The same five steps apply when you ask me to review an existing German version. We define the review scope and criteria in writing before work begins.
Responsibility
Translation does not replace regulatory review
I provide the linguistic and terminological work. Your regulatory affairs team reviews and releases the submission internally, the competent authority decides on the approved wording, and responsibility for the product information remains with the marketing authorisation holder. My translation does not make a medicinal product eligible for marketing authorisation, does not replace regulatory review, and is not legal or regulatory advice. My role is to render the English source accurately in German and to keep the defined terms distinct throughout.
For regulatory affairs and procurement
Scope, standard wording and boundaries
Which pharmaceutical documents are within scope?
Summaries of product characteristics, package leaflets, labelling, and documentation from authorisation and variation procedures where it bears on the product information. I work exclusively from English into German, and I take professional responsibility for that document family.
How is prescribed standard wording handled?
I adopt it rather than rewrite it. Where a template departs from the version that applies to your product, or where two of your documents express the same point differently, I raise a query instead of deciding for you. The decision is recorded so that it can be applied consistently to subsequent documents.
Are pharmacovigilance documents or clinical study reports covered?
No – neither belongs to the service described here, not even occasionally. Clinical study materials are different: I handle protocol summaries, including the plain-language version, and the documents given to participants, namely participant information and informed consent forms – for medicinal product trials and medical device investigations alike. That work is described under Medical & MedTech.
Can one body of terminology cover both medicinal product and medical device texts?
Yes, provided it records document type and applicable template. Different legislation, templates and terminology systems apply to the two areas. The binding German term depends on the document type and the applicable template: instructions for use address the user of a medical device, a package leaflet the patient taking a medicinal product. Without that distinction, the kind of errors illustrated on this page can arise.
Document type and stage of procedure
Tell me which text is coming up
Document type, stage of the procedure, volume, file format and deadline are all I need. We settle the route for confidential files first.