EU Summary of Product Characteristics

Draft SmPC sections from approved core content and regional requirements. Work in Microsoft Word with source context and checks that support your team’s review.

Book a demo on this document Explore the workflow

How this document gets written today

For Regulatory Affairs and Labelling, producing a EU SmPC document means bringing together evidence, template requirements and specialist decisions.

Source versions and missing inputs need to remain visible throughout drafting and review. A polished paragraph alone does not establish that the document is complete or supported.

What your team can work on

EMA QRD structure and sponsor conventions

Structured SmPC draft

Prepare and review this output against the agreed sources and sponsor requirements.

Source alignment

Prepare and review this output against the agreed sources and sponsor requirements.

Review of changed sections

Prepare and review this output against the agreed sources and sponsor requirements.

How it works for EU SmPC

Define the task

Confirm the EU SmPC sections, source versions and review criteria.

Supply the inputs

Upload the approved material and identify decisions or data still outstanding.

Draft and check

Draft by section and inspect QC findings against the source context.

Review in Word

Resolve findings, edit the document and approve through your established process.

What it drafts from

Select the approved sources for the task. Data handling follows the deployment and model-service configuration agreed with your team.

CCDS
Current SmPC
Approved safety and clinical sources

What stays with your team

PharmAssist supports your document workflow. Interpretation, medical and regulatory judgement, approval and submission stay exactly where they are today, with qualified people and your existing review chain.

Choose GenText-hosted SaaS or a private deployment. Confirm access, data handling, model services and retention during supplier qualification.

Security and deployment detail

Questions we are asked about this document

How do we establish the scope for our team?

Start with a working discussion of your documents, sources and review process. We confirm the demonstration scope and agree templates, acceptance criteria and delivery requirements for a paid pilot.

Who reviews and approves the document?

Your qualified specialists retain scientific interpretation, quality review and approval. PharmAssist provides drafting and QC assistance; unresolved inputs remain visible for your team.

Do we need a Veeva connection to begin?

A demonstration can start with synthetic documents and upload. Customer source-system connections are separately scoped during implementation.

Teams that start here often widen to

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Translate the protocol into participant-facing information for expert review.

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Clinical Study Reports

Prepare the integrated account of a study’s conduct and results from approved source material.

See every document family

Talk to us about EU SmPC

Tell us your role, source material and next document milestone. We will confirm the demonstration scope and define a paid pilot with your team.

Prefer email? alex@gentext.ai