SmPC, PIL & Labelling for centrally and nationally authorised medicines.
Alnexia authors and maintains the full EU product information set — Summary of Product Characteristics (SmPC, Annex I), labelling (Annex IIIA) and Package Leaflet (PIL, Annex IIIB) — to the latest EMA QRD human template, across all 24 official EU languages.
What we deliver
QRD-compliant authoring
Annex I/II/III drafting against the current EMA Quality Review of Documents template.
Variations & line extensions
Type IA/IB/II variations, renewals, transfers and PSUSA-driven updates.
24-language translations
Linguistic review with EU mother-tongue reviewers and QRD form/style adherence.
User testing (readability)
Coordinated PIL user testing per Article 59(3) of Directive 2001/83/EC.
Mock-ups & specimens
Mock-ups and specimens prepared per EMA mock-up guidance for submission.
Centralised, MRP, DCP & national
CAPs via EMA plus DCP, MRP and purely national procedures in any Member State.
Aligned to QRD v10 and the EU ePI Common Standard
Every SmPC and PIL we deliver is QRD-conformant and structured so its content can be lifted directly into the EU ePI HL7 FHIR Common Standard (hl7.eu.fhir.epil v1.0.0) when the product enters the PLM Portal ePI pilot — no re-authoring required.
Artefacts you receive
- Annex I — SmPC (Word + tracked changes)
- Annex II — Conditions of MA
- Annex IIIA — Labelling
- Annex IIIB — Package Leaflet
- QRD comparator and translation pack
- User-testing report (where applicable)
Sourced from regulators and industry leaders
- EMA QRD templates — European Medicines Agency
- Directive 2001/83/EC, Article 59(3) — readability — EUR-Lex
- EMA mock-up guidance — European Medicines Agency
Ready to scope this work?
Talk to an Alnexia specialist about timelines, deliverables and pricing — no obligation.
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