How do you translate pharmaceutical labels, package leaflets and product information correctly without changing the approved medicine? Treat the SmPC or equivalent professional information, package leaflet and labelling as one controlled regulatory set. Accurate pharmaceutical translation must preserve product name, active substance, strength, pharmaceutical form, route, indication, population, contraindications, warnings, approved administration information, adverse reactions, storage, pack information and lifecycle version. A small target-language change can make the medicine appear authorised for a different use or communicate a different safety profile.
People searching for pharmaceutical translation, package leaflet translation, SmPC translation, pharmaceutical labeling translation, drug label translation, patient information leaflet translation, medicine leaflet translation and regulatory product information translation are dealing with highly structured content. EMA’s product-information framework, for example, treats the SmPC, package leaflet and labelling as linked marketing-authorisation information and uses QRD templates to support clarity, consistency and accurate multilingual versions. Translation therefore must preserve both clinical meaning and template discipline.
This guide explains how to translate authorised pharmaceutical product information without changing its meaning. It covers identity, strength, form, route, indications, warnings, adverse reactions, patient wording, standard templates, small-pack labels, readability, lifecycle changes, market localisation, combination products and final artwork QA. It is about translation integrity, not medical advice or independent medicine-use guidance.
Pharmaceutical Translation Is Product-Information Preservation
Authorised medicine information is a linked system. Professional product information describes the medicine for healthcare professionals; package leaflets explain approved information to patients; labelling connects the authorised medicine to the pack, strength, pharmaceutical form, route and required warnings. Translation must preserve the same medicinal product, same approved indication, same strength, same contraindications, same warnings, same adverse-reaction information and same lifecycle version. A target leaflet can sound fluent and still be wrong if it broadens an indication, changes a dosage-form term, weakens a warning or disconnects the patient wording from the professional product information.
1. Identify the Product-Information Set
Before translating, inventory the product information: Summary of Product Characteristics (SmPC or equivalent professional document), package leaflet or patient information leaflet, outer packaging, immediate packaging, blister or small-container text, device components if present, administration instructions and supporting regulatory templates. EMA describes product information as including the SmPC, package leaflet and labelling. Treat these documents as one controlled set. A term approved in the professional document should not acquire a different clinical meaning in the leaflet or pack.
2. Record the Marketing-Authorisation Product Identity
Capture invented or brand name, active substance, strength, pharmaceutical form, route, marketing-authorisation holder, product code and source version. Product identity should remain consistent across all target documents. Do not translate a brand name by dictionary meaning. If multiple strengths exist, keep strength identifiers precise so one leaflet or label cannot be confused with another product presentation.
3. Preserve Strength Exactly
Strength can be expressed in mg, mg/mL, micrograms, percentages or other units. Protect number, unit, denominator and relationship. A fixed-combination product can display several strengths together, and the order can matter. Do not change decimal places or slash-separated strengths through formatting. Run a dedicated numerical QA pass across all product-information components.
4. Preserve Pharmaceutical Form
Tablet, capsule, solution, suspension, cream, patch and other forms are regulated product terms rather than casual descriptions. Use approved target-language standard terms where available. EMA guidance, for example, points applicants toward standard pharmaceutical-form terminology. Do not replace one dosage form with a more familiar word if the technical form differs. Patient leaflets may add a plain explanation where approved, but the product identity remains exact.
5. Preserve Route of Administration
Oral, intravenous, subcutaneous, topical, inhaled and other routes are distinct. Translate using standard medical terminology and preserve route qualifiers. Do not infer a route from the dosage form. If the source product information contains route-specific warnings or instructions, keep them attached to the correct product presentation.
6. Translate Indications Conservatively
An indication defines the approved condition, patient population and sometimes line of treatment or combination use. Preserve every qualifier. Do not broaden “for adults with…” into “for patients with…”. Do not remove “in combination with” or “after failure of” if those conditions are part of the approved indication. Translation should not expand what the medicine appears authorised to treat.
7. Preserve Age and Population Limits
Product information can distinguish adults, adolescents, children, elderly patients, renal/hepatic subgroups, pregnancy populations or other groups. Translate age ranges and population descriptors exactly. “12 years and older” differs from “older than 12.” Do not generalise subgroup wording for readability.
8. Preserve Contraindications
Contraindications should retain prohibition, condition and population scope. Do not soften “must not be used” into “not recommended” or strengthen a caution into a contraindication. If a contraindication includes hypersensitivity to the active substance or excipients, use the approved names consistently with the composition section.
9. Preserve Special Warnings and Precautions
Warnings and precautions can contain conditions, monitoring statements, symptom triggers and population-specific advice. Keep headings and hierarchy. Do not combine separate warnings because the target language could express them more compactly. Preserve limiting words such as only, unless, immediately, if, before and after.
10. Keep Professional and Patient Warnings Aligned
The patient leaflet may express a professional warning in clearer lay language, but it should not change the underlying risk. Maintain a concept map linking professional terminology to approved patient-facing wording. If the SmPC warning changes in a lifecycle update, review the dependent leaflet language and labels as part of the same change.
11. Preserve Posology and Administration as Approved Source Content
Professional product information may contain dose, frequency, duration, titration and administration details. Translation should reproduce the approved source exactly and must not become independent medical advice. Protect numbers, units, time intervals and conditions. Apparent source errors should be queried through regulatory/medical channels rather than corrected by the translator.
12. Preserve Dose Adjustments and Conditions
Dose adjustments can depend on age, organ function, interactions, adverse effects or response. Keep who, when and under what condition. “Reduce to X if…” is different from “consider reducing…” and from “do not exceed X.” Modality and conditional logic matter.
13. Preserve Maximum and Minimum Values
Maximum daily dose, minimum interval, treatment duration and other thresholds require exact translation. Search for maximum, minimum, at least, no more than, every, not more frequently than and similar phrases. Numerical values should be checked against tables, labels and patient instructions.
14. Preserve Missed-Dose Wording
Patient leaflets can include approved instructions for missed doses. Translate the source wording clearly without adding personal advice. If the source distinguishes “take as soon as remembered” from situations where the next dose is near, preserve that conditional structure. Do not improvise dosing guidance.
15. Preserve Overdose Information as Source Content
Professional and patient information may describe what to do in case of overdose. Translate the approved text accurately and keep contact or emergency advice exactly as authorised. Do not add treatment information, thresholds or reassurance from outside the source.
16. Translate Composition Consistently
Active substances and excipients should use approved target names. Keep strength and quantity relationships exact. If the leaflet highlights an excipient because of a known effect or regulatory requirement, preserve that information and terminology. Do not turn an excipient into an active ingredient through wording or table layout.
17. Preserve Active-Substance Identity
Generic, common or international nonproprietary names can have official forms. Use the approved target term where required and keep it consistent across title, composition, indications and safety sections. Do not translate a scientific substance name creatively. Product identity depends on nomenclature stability.
18. Preserve Excipients and Contains Statements
Patient leaflets and labels can include “contains” statements, warnings for certain excipients and quantities. Translate them using approved terminology and preserve numbers. Do not remove an excipient because it seems clinically minor. The target set should match the authorised source.
19. Translate Adverse-Reaction Categories Carefully
Adverse reactions may be grouped by system organ class, frequency or seriousness. Use controlled medical terminology and preserve frequency categories. Do not replace a formal adverse reaction with a broader everyday symptom unless the patient leaflet source itself uses a lay form. Professional and patient documents can use different registers while remaining conceptually aligned.
20. Preserve Frequency Categories
Very common, common, uncommon, rare, very rare and not known can have defined frequency ranges under particular regulatory systems. Translate the approved category term consistently. Do not substitute casual words such as “sometimes” unless that is the approved patient-language wording. Frequency categories are structured risk information.
21. Preserve Not Known Versus Rare
A reaction whose frequency is not known is not necessarily rare. Do not treat unknown frequency as low frequency. Keep status categories separate. This is a simple example of how conversational simplification can alter safety meaning.
22. Preserve Seriousness and Severity Distinctions
Professional product information can distinguish serious reactions from severe intensity. Do not translate the two with one target word if the source differentiates them. Use the medical/regulatory glossary and keep the distinction stable across product information, safety communications and clinical materials.
23. Translate Interaction Sections Precisely
Interactions may involve other medicines, foods, alcohol, laboratory tests or physiological conditions. Preserve the substance or class, effect and condition. Do not broaden an interaction to all medicines in a category unless the source does. Patient-facing text can use simpler language while keeping the same interaction scope.
24. Preserve Pregnancy, Fertility and Breastfeeding Sections
Use approved medical terminology and preserve whether information concerns pregnancy, breastfeeding, fertility or contraception. Do not turn a risk statement into medical advice beyond the source. If the professional document and patient leaflet use different registers, keep concept correspondence visible.
25. Preserve Driving and Machine-Use Wording
Product information can describe effects relevant to driving or operating machines. Translate the approved level of caution and conditions exactly. Do not replace a conditional statement with a blanket prohibition or vice versa. Use one target phrase across professional and patient documents where the regulatory template expects alignment.
26. Preserve Storage Conditions
Storage information can include temperature, freezing, light, moisture, container closure and use-after-opening periods. Protect all numbers and conditions. “Do not freeze” is not “keep refrigerated.” Review pack labels and leaflet storage statements together. If target-market packaging includes temperature symbols, make sure text and symbol agree.
27. Preserve Shelf Life and In-Use Periods
Shelf life, expiry date and period after opening or preparation can be different concepts. Translate each distinctly. Protect dates, time units and conditions. A target leaflet should not imply the medicine remains usable for the full shelf life after opening if the source provides a shorter in-use period.
28. Keep Disposal Information Within the Approved Source
Patient leaflets may contain medicine-disposal advice authorised for the target market. Translate the approved wording and do not add local disposal instructions without regulatory authorisation. If localisation requires country-specific wording, record it as an authorised market adaptation rather than an informal translation change.
29. Translate Package Leaflets for Comprehension
Patient leaflets should be understandable without losing approved meaning. Use clear target-language syntax, stable terminology and direct headings. Avoid unexplained technical terms where the source uses lay language. EMA’s product-information framework treats the package leaflet as patient-facing information derived from the professional product information. Readability should support, not rewrite, the approved content.
30. Preserve Leaflet Section Architecture
Package leaflets often use a standard structure: what the medicine is and what it is used for, what to know before use, how to use it, possible side effects, storage and pack contents/other information. Keep required headings and order according to the relevant template. Structure helps patients find information quickly.
31. Preserve Before-You-Take/Use Logic
Patient leaflets group contraindications, warnings, other medicines and special populations before administration instructions. Do not move safety information simply for stylistic flow if the regulatory template expects a fixed structure. Translation should work within the approved information architecture.
32. Preserve Patient Action Triggers
Phrases such as “stop taking and seek medical help,” “tell your doctor,” or “contact a healthcare professional” have different action levels. Translate them exactly as approved. Do not intensify or weaken urgency. This article does not provide medical advice; it explains how to preserve the authorised patient instruction.
33. Preserve Contact Details
Leaflets may identify the marketing-authorisation holder, manufacturer, local representative or reporting contacts. Translate role labels, not the company identity unless an official target form exists. Verify addresses, telephone numbers and websites. Contact blocks often bypass ordinary language review and deserve separate QA.
34. Translate Outer-Pack Labelling Under Space Constraints
Outer packaging can contain product name, strength, form, quantity, route, warnings, expiry, batch and storage information. Target-language expansion is a design challenge, not permission to delete mandatory content. Use approved short terms and regulatory templates. Review final artwork at actual size.
35. Translate Small Immediate-Pack Text Carefully
Blisters, strips, ampoules and other small containers can have very limited space. Regulators may permit standard short terms in defined contexts. Use the approved target short forms; do not invent abbreviations. Product name, strength and critical identifiers must remain unambiguous.
36. Keep Pack and Leaflet Product Names Identical
The invented name, strength and pharmaceutical form should follow the authorised naming pattern consistently. A small difference in ordering or strength notation can make packs appear to contain different products. Protect product-name strings as controlled content.
37. Preserve Batch and Expiry Labels
Batch/lot labels and expiry fields are structured data. Translate the field label using the approved term and protect the actual code/date. If a target market uses a specific date order, implement it consistently and verify final artwork. Avoid ambiguous numeric dates where policy provides a clearer format.
38. Preserve Accessibility-Related Product Naming Under Approved Processes
Some markets have accessibility requirements for packaging. Translation teams should work within the manufacturer’s regulatory and packaging process. Do not independently transliterate or shorten product names for tactile or other accessible formats. Accessibility implementation can have technical constraints beyond ordinary text translation.
39. Preserve QRD or Other Regulatory Template Phrases
Where regulators publish multilingual standard templates, use them as the primary phrase source. EMA’s QRD system provides standard headings, terms and phrases across official languages and emphasises consistency between language versions. Store approved template strings in the termbase and avoid stylistic variation.
40. Preserve Marketing-Authorisation Lifecycle Changes
Medicine information changes as new safety, efficacy or quality data emerge. Track source version, variation, target language and effective date. When the SmPC changes, identify dependent leaflet and label sections. Do not leave a patient leaflet on old wording after the professional information changes.
41. Use Change-Impact Mapping
A change to indication, warning, adverse reaction, storage condition or company contact can affect multiple documents. Maintain a matrix linking source sections to target documents. This reduces the chance that one language or one pack component remains stale. Lifecycle translation is document governance.
42. Preserve Variation-Specific Scope
A regulatory variation may change only certain strengths or pharmaceutical forms. Apply the update only to affected product presentations. Do not propagate wording to another strength automatically. Product applicability should be stored in translation-memory context.
43. Build a Pharmaceutical Termbase by Document Type
Store professional term, patient-facing equivalent, standard template phrase, active-substance name, pharmaceutical form, route, adverse-reaction term and market-specific notes. One concept can legitimately have a technical SmPC term and a simpler leaflet form. Context fields prevent the simpler term from leaking into professional content.
44. Use Translation Memory With Version Awareness
Product information repeats heavily. Reuse is useful but risky when a strength, population, warning or frequency changes. High-percentage matches containing numbers, negation or safety terms should receive active review. Only approved final target text should enter the trusted memory.
45. Protect Numbers, Units and Codes
Extract strengths, concentrations, frequencies, durations, storage temperatures, pack sizes, dates and product codes. Compare source and target systematically. Automated QA can detect differences but cannot know whether an authorised localisation explains them. Record intentional changes.
46. Preserve Tables and Lists
Adverse-reaction tables, dose tables, ingredient lists and pack-size lists are relational structures. Review row/column alignment after layout. A translated label placed beside the wrong strength or reaction category creates a factual error even if the wording is correct.
47. Preserve Superscripts, Subscripts and Symbols
Product information can contain scientific notation, units and symbols. Ensure fonts and file conversion preserve them. A misplaced micro symbol or decimal point can change a value. Final PDF review should include typography as well as language.
48. Translate Product Websites From the Approved Information
Public medicine-information pages may summarise authorised product information. Keep them aligned with the current label and leaflet, and do not introduce unapproved claims. Marketing teams should not use translation as a back door to broader indications or stronger benefits. Use the official product-information set as the terminology source.
49. Preserve Medication-Error Prevention Wording
Product names, strengths, routes and instructions may be designed to reduce confusion. Do not introduce abbreviations or synonyms that increase similarity between products. Target-language naming should follow the manufacturer’s approved medication-error strategy and regulatory conventions.
50. Distinguish Professional IFU From Package Leaflet
Some medicines have separate administration Instructions for Use in addition to the package leaflet. Treat them as distinct documents with linked terminology. Action sequences, diagrams and device components require technical-procedure QA, while the leaflet provides broader patient information. Keep cross-references accurate.
51. Translate Combination Products Consistently
A medicine can be supplied with a device or delivery system. Product information then spans pharmaceutical and device terminology. Use linked termbases and review both the medicine and device components. The newer medical-device IFU and labelling owner provides the device-document layer.
52. Preserve Instructions for Preparation
Professional or patient information may describe preparation, reconstitution or handling as approved source content. Translate sequence, quantities and conditions exactly and do not add procedures from outside the source. This guide is about translation integrity, not medicine-preparation advice.
53. Preserve Appearance Descriptions
Product information can describe colour, shape, markings, score lines or solution appearance. These descriptions help identify the medicine. Translate the physical description precisely and preserve alphanumeric imprints. Do not use a colour term with a materially different target-language meaning.
54. Preserve Pack-Size Information
Package sizes can vary by market. Translate the approved target-market list and keep quantities attached to the correct presentation. Do not assume all source-market pack sizes are sold in the target market. Regulatory localisation should provide the authorised content; translators should not invent the commercial presentation.
55. Preserve Local-Representative Information by Market
EU and other multi-market product information can include local representative details. Treat market-specific contact blocks as controlled localisation data. Do not copy a representative from another country because the language is shared. Version control should include market as well as language.
56. Preserve Reporting-of-Side-Effects Information
Patient leaflets can explain how to report suspected side effects. Translate the approved reporting route, authority name, website and contact details accurately. Do not provide medical interpretation. Market-specific reporting information should be authorised by the regulatory owner.
57. Distinguish Translation From Medical Review
Translators transfer the approved medicine information. Medical reviewers confirm clinical terminology and concept accuracy. Regulatory reviewers confirm authorised wording and templates. Do not ask the translator to decide whether a warning should be added, whether an indication should be broadened or whether an adverse reaction belongs in a different frequency category.
58. Distinguish Translation From Regulatory Localisation
Target markets can require different template wording, contacts, pack information or regulatory references. Record those changes separately from base translation. This makes it possible to trace which wording came from the source and which came from authorised local requirements. Hidden localisation changes make future lifecycle updates difficult.
59. Review Final Artwork and Leaflet Layout
Target text expansion can affect folds, columns, font size and proximity of warnings to headings. Review the final printed or PDF leaflet and pack artwork. Check page order, cross-references, tables, symbols and small-pack legibility. A correct bilingual file can still fail in the final physical product if layout breaks meaning.
60. Version-Control Superseded Leaflets
When product information updates, archive old target versions with clear superseded status and maintain the release history. Do not let outdated leaflets remain publicly accessible without context if the organisation’s process requires removal or archiving. Product-information translation is lifecycle management.
61. Preserve Reference-Label Governance
Global pharmaceutical organisations often maintain a reference or core product-information source from which local texts are derived. Record the authoritative source version and do not combine wording from multiple references without an approved change. If a local target document legitimately differs, document the local reason. Reference-label governance helps every language remain anchored to the same approved medicine information.
62. Translate Readability-Test Materials Consistently
Some patient leaflets undergo readability or user-testing processes. If the target language is tested, the wording used in testing should match the release candidate unless approved changes are documented. Questions asked during readability evaluation should refer to the same target section and concept. Readability work is not separate from translation lifecycle control.
63. Use Patient Comprehension Feedback Through Controlled Revision
If target-language users misunderstand a leaflet phrase during formal testing, route the issue through the authorised regulatory/editorial process. Do not let reviewers make local informal fixes that never reach the termbase or other strengths. Confirmed changes should propagate to related leaflets and future product information where applicable.
64. Keep Pharmacovigilance Communications Aligned
Safety letters, risk-minimisation materials or other pharmacovigilance communications may reuse product-information terminology. Maintain the same active-substance names, adverse-reaction terms, patient populations and action wording where the approved source aligns. A post-authorisation safety communication should not introduce a contradictory target term simply because another team translated it.
65. Preserve Educational and Risk-Minimisation Materials
Some medicines have additional materials for healthcare professionals or patients. Treat them as approved product-associated content, not marketing. Keep required risks, eligibility conditions and actions aligned with the authorised source. If the material contains diagrams or checklists, review layout and sequence as well as language.
66. Reconcile Pack Artwork Against the Final Leaflet
Before release, compare product name, strength, form, storage, warnings, company details and reporting information between final pack artwork and leaflet. Artwork may be produced in a separate system and can lag behind text changes. A cross-document reconciliation pass catches divergences that no single-document reviewer will see.
67. Maintain Language Packs as Controlled Sets
For multi-country submissions, treat each language’s SmPC, leaflet and labelling as one controlled package. Record language, country, product presentation, version and approval status. Do not mix an approved leaflet from one variation with pack text from another. Language-pack integrity makes later lifecycle updates far easier to manage.
68. Propagate Safety Changes Across All Languages
When an authorised safety change is approved, use a change-impact matrix to identify every affected language and presentation. Track completion and approval status. High-risk safety wording should not be updated in some major languages while smaller markets remain on the previous version. Multilingual lifecycle governance is part of patient-information quality.
69. Preserve Local Digital Product Information
Electronic product information, QR-linked leaflets and digital repositories can supplement or mirror printed material. Keep them synchronized with the current approved target version and verify links. Digital availability does not remove the need for version control. A user should not reach an outdated target leaflet through a live QR code.
70. Audit Product Information After Organisational Changes
Manufacturer addresses, local representatives, websites and contact channels can change independently of clinical content. Include administrative fields in periodic target-language audits. A leaflet can become operationally wrong even when its clinical text remains current. Treat contact and ownership changes as controlled lifecycle events.
Worked Example: Indication
Source: “For the treatment of Condition X in adults who have not responded adequately to Treatment Y.” The target must preserve condition, adult population and prior-treatment condition. Omitting “who have not responded adequately” broadens the indication. Translating “treatment” as “prevention” changes purpose.
Worked Example: Frequency Category
Source lists an adverse reaction as “uncommon.” The target should use the approved regulatory equivalent, not a casual phrase such as “very rare.” Frequency categories carry structured meaning. Keep the same term in the table and patient explanation where the approved template requires it.
Worked Example: Strength and Form
Product name: ExampleMed 20 mg/mL oral solution. The target must preserve brand name, 20 mg/mL strength and oral-solution form. Do not shorten to “20 mg medicine” on a formal pack field because that loses denominator and form.
Worked Example: Storage
Source: “Store below 25°C. Do not freeze.” The target should preserve both conditions. “Keep refrigerated” would introduce a new requirement; “protect from cold” would weaken the explicit no-freezing instruction. Check the pack label and leaflet together.
Pharmaceutical Translation QA Matrix
Review product identity, strength, pharmaceutical form, route, indication, population, contraindications, warnings, approved administration information, ingredients, adverse reactions, frequency categories, interactions, storage, shelf life, pack sizes, contact details, template phrases, product codes, revision status, language-pack status and market-specific authorised adaptations separately. Then perform cross-document and final-artwork review. Product-information consistency is the central quality objective.
A Seven-Pass Pharmaceutical Review
Use a product-identity pass; an indication/safety pass; a terminology/template pass; a numerical pass; a professional-versus-patient alignment pass; a market-localisation pass; and a final artwork/leaflet pass. Combination products may need an additional device-procedure review. High-consequence content should receive qualified medical and regulatory review under the marketing-authorisation holder’s process.
Common Failure Modes
Common errors include broadening an indication, changing a strength denominator, using the wrong pharmaceutical-form term, weakening a contraindication, changing a frequency category, confusing serious and severe, letting patient wording drift from professional information, translating an outdated SmPC, using the wrong local representative, copying a pack size from another market and shrinking mandatory label text until it becomes unreadable. These failures arise when pharmaceutical product information is treated as general medical prose.
Authoritative Reference Route
For EU product information, EMA’s QRD templates and product-information guidance provide standard headings, phrases and terminology across languages, and the SmPC forms the basis for healthcare-professional information and preparation of patient leaflets. Other markets have their own regulators and formats. Translation teams should use the controlling authority and marketing-authorisation holder’s approved source for the actual product.
How AI Can Help
AI can help extract terms, compare product-information versions, flag mismatched strengths and identify inconsistent repeated phrases. It can support low-risk drafting in approved secure environments. It should not invent indications, dosing, warnings, adverse reactions or regulatory wording. Human medical and regulatory verification remains essential.
Practice and Transfer
Use a fictional training product with a made-up name, harmless ingredients and no real treatment claim. Create a mock professional summary, leaflet and box label containing strength, form, storage, fictional warnings and pack size. Translate the set and verify identity, numbers, terminology and cross-document alignment. This trains product-information discipline without giving real medicine-use advice.
Frequently Asked Questions
What is pharmaceutical product-information translation?
It is the translation of authorised professional product information, package leaflets and labelling while preserving medicine identity, approved use, safety information and lifecycle traceability.
What is an SmPC?
The Summary of Product Characteristics is professional product information used in some regulatory systems, including the EU.
Can patient leaflets use simpler language?
Yes within the approved regulatory framework, but simplification must preserve the underlying authorised meaning.
Can a translator change a warning or dose that looks wrong?
No. Apparent source problems should be escalated to the marketing-authorisation holder’s medical/regulatory process.
Can AI translate package leaflets?
AI can assist with controlled drafting and QA, but authorised safety, indication and regulatory language requires accountable human review.
Where This Article Sits in the Translation Architecture
This article owns the authorised pharmaceutical product-information lane inside Master Art of Translation. It complements the newer Clinical Trial Protocols, Consent and CRFs owner and the existing Medical Documents and Patient Information owner. It also connects to Terminology and QA.
The Principle to Keep
Pharmaceutical product-information translation is correct when the target pack, professional information and patient leaflet still describe the same authorised medicine, with the same strength, form, indication, safety profile and lifecycle version. Translate the approved medicine-information system, not a new clinical interpretation.