Labelling is the part of the dossier that companies leave until last and then discover cannot be rushed. User testing takes weeks and needs real participants. Braille has to be designed into the carton. And the national Blue Box means the pack you approved for one market will not do for another.
Where the rules live
Title V of Directive 2001/83/EC — Articles 54 to 69, including the inserted Articles 54a and 56a — governs labelling and the package leaflet. Article 54 lists the mandatory particulars on the outer packaging; Article 55 sets reduced lists for blisters and small immediate packaging units; Article 56 requires that particulars be easily legible, clearly comprehensible and indelible. Article 65 gives the Commission the mandate for detailed guidance on legibility, which is where the readability guideline comes from.
Greece transposes Title V at Articles 77 to 94 of Ministerial Decision Δ.ΥΓ3α/Γ.Π. 32221/2013. The numbering does not track the Directive, so cite the Greek article, not the EU one, when corresponding with EOF.
User testing: the 90/90 rule
Article 59(3) requires the package leaflet to reflect the results of consultations with target patient groups, and Article 61(1) requires those results to be submitted with the application. The Commission’s readability guideline (Revision 1, 12 January 2009) sets out the method most companies follow:
- One-to-one, face-to-face structured interviews with at least 20 participants, typically a pilot of three to six, then a round of ten, then a further ten on the final leaflet.
- Doctors, nurses and pharmacists are excluded.
- Usually 12 to 15 questions, in a test designed to run no longer than 45 minutes.
- The success criterion: the information must be found by 90% of participants, of whom 90% can show they understand it — 16 of 20 for each individual question. Results cannot be aggregated across questions, and it need not be the same 16 people each time.
Testing is normally expected for a first authorisation of a product with a new active substance, a change in legal status, a new presentation, or a particular critical safety issue. Consulting in one EEA language is usually sufficient, with results presented in English. Compliance with the QRD template does not exempt you from testing.
Braille and accessible formats
Article 56a requires the name of the medicinal product in Braille on the packaging, and requires the holder to make the leaflet available on request from patients’ organisations in formats appropriate for blind and partially sighted people. The guidance sits in Chapter 2 of the 2009 readability guideline:
- Uncontracted Braille, with Marburg Medium cell size strongly recommended.
- The invented name and strength; for single-strength products the name alone is acceptable.
- Required on the outer or secondary packaging only — not on blisters or ampoules.
- Small packages of up to 10 ml may use contracted Braille, defined abbreviations or a supplementary tab label.
- No Braille is needed for products administered only by healthcare professionals, vaccines being the worked example.
- On multilingual packs, the name must appear in Braille in every language concerned.
For accessible leaflets, the guidance points to sans serif type at 16 to 20 point, black on white, with audio formats recommended for blind users. Parallel importers and distributors carry the same obligations.
Typography, language and the Blue Box
The leaflet minimum is 9 point measured in Times New Roman, not narrowed, with line spacing of at least 3 mm; labelling is at least 7 point with the same line spacing. Justified text should be avoided.
Article 63 requires the particulars in an official language of the Member State of marketing; Greek Article 88 requires Greek. Multilingual packs and leaflets are expressly permitted, provided the same information appears in every language — which is what makes Greece, Cyprus and Balkan packs workable, and what makes the Braille requirement multiply.
Article 57 lets Member States require national particulars — the Blue Box. For Greece the Commission’s packaging guideline records that the price must appear on the label, that reimbursement conditions need not, that narcotics carry specific red or green legal-status wording, and that all products must carry the EOF safety coded sticker (27 mm × 24 mm, issued free by EOF) on the outer pack, with the company adding product name, form, strength, EOF code and retail price. The Greek national text additionally requires the recycling symbol on the outer packaging — a divergence worth checking artwork against.
One useful practical rule: under Greek Article 86(3), changes to labelling or the leaflet not linked to the SmPC are approved tacitly if EOF raises no objection within 90 days.
How PQRA helps
We review SmPCs, leaflets, labelling and mock-ups against the QRD template and the readability guideline, design and manage user-testing programmes and bridging reports, resolve Greek Blue Box and safety-sticker requirements, and build multilingual artwork strategies for Greece and neighbouring markets so one pack serves more than one country.
Artwork on the critical path? Get PQRA involved before the mock-ups are finalised.
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