Labelling, SmPC and Prescribing Information Writing for Licence Holders
Pubrica writes product labelling for licence holders, including summaries of product characteristics, package leaflets, US prescribing information and company core data sheets. Prescribers rely on labelling in practice, and a single word can change what a company may claim and what a patient is told. Our labelling writers prepare each document to the required format and keep the documents consistent with one another across markets.
- EU QRD template and US PLR format handled as distinct documents rather than one translated into the other
- Company core data sheet as the reference document, with local labels traced back to it so that any divergence is deliberate
- The package leaflet written for a patient, at the reading level that user testing expects rather than as a compressed SmPC
- Consistent with the risk management plan, because differences in how the RMP and the label describe the same risk will raise assessor questions
- Controlled change management so that a safety update to the core data sheet is carried through to local labels rather than reapplied by hand in each market
SmPC and package leafletIncluded
US prescribing information (PLR)Included
Company core data sheetIncluded
Local label reconciliationIncluded
Artwork and packaging operationsQuoted separately
Core sheet → regional → local → reconciled → label
- Written to the required format
- Traced to the core data sheet
- Leaflet written for a patient
- Reconciled with the RMP
- Change control across markets
Deliverables
Four Core Elements of Every Label Set
Each label set is built on one company core data sheet, and no local label may go beyond what the core sheet states.
Example from a format checkA USPI written by translating an SmPC reads wrong to a US reviewer immediately, and the Highlights section has no SmPC equivalent to translate from.
Example from a package leafletHypersensitivity reactions including anaphylaxis have been reported.Some people have had serious allergic reactions to this medicine. Signs include a rash, swelling of the face or throat, and difficulty breathing. If this happens, stop taking it and get medical help straight away.
Example from a label reconciliationWhen four markets carry four slightly different versions of the same warning, no one can say which is intended. Anchoring every label to a core sheet makes divergence visible and auditable.
Example from a consistency checkDivergence between the label and the RMP is an easy question for an assessor to raise and a time-consuming one to answer, because it usually means deciding which document was correct.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Four Governing Standards and Guidelines for SmPC and Product Labelling
Each market mandates a specific structure for product labelling, so format is a regulatory requirement rather than a matter of style.
EU product information (QRD template, SmPC and leaflet)
The mandated structure and standard wording for the summary of product characteristics, labelling and package leaflet in the EU.
US prescribing information (201.56 and 201.57)
The Physician Labeling Rule format: Highlights, Full Prescribing Information and the required section order.
Risk management systems (consistency with the RMP)
The label and the risk management plan must describe the same risks. Divergence between them can raise assessor questions and, in some cases, findings.
Quality management (cert. H3CR9TCU20251212INDQM10N)
How the document is drafted, reviewed, version-controlled and released.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to its evidence and to a responsible individual. For this reason, we treat source traceability as more important than drafting speed, and every statement in a regulatory document must be traceable to its source.
Why We Do Not Publish an AI Accuracy Figure
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How We Write Your SmPC and Labelling
We establish the core data sheet first, because every downstream label must trace to it.
Core data sheet
We establish or review the company position on indications, dosing, contraindications, warnings and adverse reactions as the reference for every local label.
Regional documents
We write the EU SmPC to the QRD template and the US prescribing information to PLR format, each as a separate document rather than a translation of the other.
Patient-facing leaflet
We write the package leaflet for a patient reader, prepare it for user testing and place the important safety information where it will be read.
Reconciliation and change control
We trace local labels back to the core sheet, record differences as decisions and set up a change process so that a safety update is carried through rather than reapplied by hand.
Our Experts
Our Regulatory Writing Team
A named team of regulatory specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. Each expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
SmPC and Labelling Writing Packages
Pricing depends on product complexity, the number of markets and whether a core data sheet already exists.
Label set
For marketing authorisation applications and new products
Quoted per projectOn product and market count
Delivery By scope
- ✓Company core data sheet
- ✓SmPC to the QRD template
- ✓Package leaflet prepared for user testing
- ✓US prescribing information in PLR format where required
- ✓Reconciled with the risk management plan
- ✓Two review cycles
Documents prepared together as a set remain consistent. Documents written separately tend to diverge from the first update onward.
Deliverables Request a quoteLabelling maintenance
For products marketed in several territories
Quoted per projectOn portfolio and update frequency
Delivery By arrangement
- ✓Safety updates applied to the core data sheet
- ✓Propagation to local labels tracked
- ✓Divergences recorded as decisions
- ✓Variations and renewals documentation
- ✓Consistency maintained with the RMP and periodic reports
Labelling maintenance is recurring work with compliance deadlines, so we provide it as a standing arrangement.
Deliverables Request a quoteSend us the core data sheet and two local labels, and we will tell you free of charge where they have diverged. In established portfolios, some divergence is common.
FAQs
SmPC and Labelling FAQs
If your question is not answered here, ask an expert — no quote is required.
No. The PLR format has a Highlights section with no SmPC equivalent, a different section order and different conventions on what belongs where, so a translated document is readily identified by reviewers.
They should be written as separate documents from a shared core data sheet, which is also what keeps them consistent when one of them changes.
Because it is user-tested for readability in the EU, and a leaflet written as a compressed SmPC fails that test. The audience is a patient, not a prescriber.
Rewriting a leaflet after a failed readability test costs more than writing it correctly first, and it can delay the application.
It is the company’s own position on the product’s safety and use, from which every local label is derived. It is not itself a regulatory submission document.
A core data sheet provides control. Without one, local labels diverge market by market and no one can say which version is intended. With one, every divergence is a recorded decision.
Artwork and packaging text can be quoted, but it is an operational workflow with its own tooling rather than a writing service, and for large portfolios it is usually better placed with a specialist provider.
We write the label content that the artwork carries, and we will tell you where a specialist artwork provider is better suited to the work.
Related Services
Related Regulatory Writing Services
The label must agree with the safety documents and the dossier that support it.
1SAFETY DOCUMENTSconsistent risk descriptions
Risk management planSafety specification and minimisation. PSUR and DSURPeriodic benefit-risk evaluation.2DOSSIER DOCUMENTSthe evidence behind label claims
CTD module summariesModule 2.5 and 2.7. Regulatory writingDossiers and submissions.3PATIENT-FACING CONTENTplain language
Plain language summaryEU CTR Annex V lay summaries. Patient education contentWritten for people affected.Request a Free Label Divergence Check Against Your Core Data Sheet
We will tell you free of charge where your local labels have diverged from the core data sheet. Divergence can develop over time, particularly in established product portfolios.