Readability Test PiL for your Module 1.3.4
Knowhownow – readability professionals since 2006
Knowhownow is a European Group of Readability test professionals, based in the Netherlands. Since 2006, we have guided over 1000 package leaflets to submission. Knowhownow conducts your PIL user tests in the UK, France, Germany, Belgium, USA and the Netherlands. We are well known for our state of the art quality and flexibility. We conduct our readability tests and IfU tests on patient instruction leaflets by guidelines issued by MhrA, EMA, AIFA, CBG-MEB, PEI, Bfarm, MSNA, FAGG.
Furthermore we have quite a track record concerning our success rate: 100% of our PIL user tests have been validated by various authorities. We continue to receive sincere compliments from the authorities on the quality of our extended reports. Submission ready for your M.1.3.4.
User test – Leesbaarheidstest Lesbarkeitstest Test di leggibilità Teste de lisibilité Läsbarhet testet
Clarity for patients. Confidence for regulators.
For 20 years, KNOWHOWNOW has supported pharmaceutical companies in making patient information clear, accessible and fully compliant. We believe that true readability goes beyond meeting regulatory requirements — it is about ensuring that patients can understand and use the information that matters to their health.
Over the years, we have built a strong reputation across Europe as a reliable and pragmatic partner for readability testing. Our clients value not only our scientific expertise, but also our flexibility, speed, and ability to seamlessly integrate into regulatory processes.
As regulations evolve and expectations increase, we continue to adapt — while staying true to our core principle: delivering high-quality, patient-focused results that stand up to regulatory scrutiny.
Services PIL user tests
Timeline:
- regular 8-10 weeks
- expedited 2-4 weeks (subject to additional fee)
Services:
- Submission-ready 1.3.4 documents (eCTD)
- Timelines possible between 2 and 10 weeks (respecting your clock-stop slots)
- Design and printing of mock-up for testing purposes
- Testing possible for all European authorities
- All PL´s, Rx, OTC and hospital products
- CP and MRP
- Bridging services
- Testing for Patient Instructions, Instructions for Use
- Experience with decades of interviewing respondents which results in a pre/test assessment of the readability of the PIL
Additional Services:
- Pilot testing of PL
- Pilot testing of protocol
- Mock up design
- Pre-test assessment
- Review of the Word text. Amendments are based on technical readabilitity, use of laymen terms, thousands of interviews etc. All in order to optimize readability (i.e. legible, clear and easy to use).
- Completion of QRD Bridging proposal
2006
Experience since 2006
1000+
Tested Leaflets
100%
Success rate
For a usertest find our fieldwork sites in (but not limited to):
United Kingdom: London, Bishops’ Stortford
France: Clichy, Paris, Colmar
Sweden: Umeå, Malmö
Germany: Dusseldorf, Kleve
The Netherlands: Nijmegen, Mook
Belgium: Liège
National authorities dealing with user consultation
| Netherlands: | Leesbaarheidstest | CbG-MeB | https:\\www.cbg-meb.nl |
| Germany: | Lesbarkeitstest | Bfarm | https:\\www.bfarm.de/ |
| Denmark: | læsbarhed test | Danish Health and Medicines Authority | https:\\www.laegemiddelstyrelsen.dk |
| France: | test de lisibilité | ANSM | https:\\ansm.sante.fr |
| Finnland: | luettavuus testi | Fimea | https:\\www.fimea.fi |
| IrEland: | Readability test | HPRA | https:\\www.hpra.ie |
| Italy: | test di leggibilità | AIFA | https:\\www.agenziafarmaco.it |
| Norway: | lesbarhet test | Norwegian Medicines | https:\\www.legemiddelverket.no |
| Spain: | test de legibilidad | SAMH | https:\\www.aemps.gob.es |
| Sweden: | läsbarhet testet | Medical Products Agency | htps:\\www.lakemedelsverket.se |
| UK: | Readability test | MHRA | https:\\www.mhra.gov.uk |
User tests
For manufacturers of medicines, Europe requests to present the leaflet in one language to consumer panels. When we test a package leaflet for readability, attention is paid to findability, comprehensibility and applicability of the information. The readability test may be a reason to further improve a package leaflet.
The readability test is a mandatory part of the European registration procedure and the test results are included in the registration dossier. Knowhownow tests package leaflets according to a fixed procedure that is based on the guidelines of the European Commission. Your contribution is very important.