Medicinal Products

Instructions on the readability and simplicity testing of the package leaflet

Instructions for marketing authorisation holders about readability and simplicity testing of the package leaflet
(Version 5, February 2026)

These instructions should be read along with the following guidelines and regulations:

• "Guideline on the readability of the labelling and package leaflet of medicinal product for human use", Revision 1, 12 January 2009
• "Guidance concerning consultation with target patient groups for the package leaflet", May 2006
• Article 59, paragraph 3 of Directive 2001/83/EZ
• Article 98, paragraph 4 and Article 99 of the Medicinal Products Act (Official Gazette No. 76/13, 90/14, 100/18 and 136/25)
• Article 82 of the Ordinance on the Marketing Authorisation of Medicinal Products (Official Gazette, No. 83/13., 28/20. and 32/21.)

Guidelines and documents published at the website of the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which are available here, should be taken into account, as well.

The package leaflet must be written in a way that is clear and understandable for users so that they could easily find and understand the information needed for a rational and safe use of the medicinal product. The content and presentation of the package leaflet impact its readability.

The comprehensibility and simplicity of the package leaflet is tested with target patient groups according to applicable European and national regulations. When evaluating readability and simplicity of the package leaflet in cooperation with target patient groups, applicant is obliged to act in accordance with current guidelines of the European Commission and instructions published on the HALMED's website.

In certain cases, HALMED may accept the preparation of a bridging report, which is described in detail in the segment "Bridging report".

Submission procedure for readability testing of the package leaflet to HALMED

Data on the readability testing of the package leaflet can be submitted as:

1. Report on the readability of the package leaflet conducted with target patient groups ("Consultation with Target Patient Group”, or "Readability user testing", RUT)
2. Bridging report

Readability testing of the package leaflet with target patient groups may be carried out in any languages ​​of the member states of the European Union and/or the European Economic Area, while the testing results should be submitted to HALMED in English or Croatian.

The applicant/marketing authorization holder may submit data on the readability testing of the package leaflet to HALMED in one of the following regulatory procedures, under the current legislation in the Republic of Croatia:

• in the marketing authorisation procedure
  • it is not separately charged, but included in the price of marketing authorisation
• by submitting a variation application
  • in the application form, the type of variation is marked as IB C.I.11 (Guidelines on the details of the various categories of variation, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use, and on the documentation to be submitted pursuant to those procedures C/2025/5045)
  • variation is charged according to the current price list

Depending on the type of report for readability testing of the package leaflet, the following documentation should be provided:

1. Report on the readability of the package leaflet conducted with target patient groups (RUT)

The structured report should include: description of the medicinal product, details of the study, questionnaire, original (and revised) package leaflet with technical specifications included, summary of results and conclusion.

The questionnaire should contain 12-15 "open” questions that evenly cover safety, efficacy and design of package leaflet. In addition, the questionnaire should cover all key safety messages from the clinical documentation and risk management plan, in particular use during pregnancy and lactation and any risk of incorrect handling, complex preparation or storage.

User testing should include pilot and minimum two rounds of at least 10 participants. Between the rounds, text changes are possible, if needed. The participants selected for a given user consultation should reflect the demographics of potential users of the medicinal product in question, and the report should include data on age, gender and educational level of the participants.

In order to facilitate the interpretation of results, comprehensive data should be submitted. Both written and graphical reports should be presented. The graphic should give the results through well-differentiated colours for the different groups of patients.

The main points to be covered in the report are:

• Ability to find information (traceability)
• Ability to use information (comprehension, applicability)
• Technical specifications and readability (letter format, layout)

Success criteria: at least 90 % of literate adults must be able to find the information requested in the package leaflet, of whom 90 % can show that they understand it, i.e. at least 16 out of 20 participants are able to find and understand the information.

When based on the readability assessment is concluded that the approved text of the package leaflet should be changed, it is necessary to submit a package leaflet proposal in a mock-up version and in the final version.

If the applicant/marketing authorization holder for the package leaflet from the Republic of Croatia submits the results of a readability testing of the package leaflet made for another applicant/marketing authorization holder/client, and the content and design of the package leaflet from the Republic of Croatia fully correspond to the package leaflet from the readability testing, it is necessary to submit:

• Statement by the Marketing Authorization Holder confirming that the package leaflet from the Republic of Croatia will have the same content and design (technical specifications should be included) as the package leaflet for which the readability testing results have been submitted.

2. Bridging report

The bridging report should be prepared on the template "QRD form for submission and assessment of user testing bridging proposals", which is available on the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) website, or here, and submitted to Agency as working (Word) document.

The bridging report should be prepared by referring to a "similar" package leaflet tested for readability with the target patient groups. In this case no significant difference in the package leaflets that are being referred to, should exist. It is also recommended that their layout and writing style be the same. It is possible to refer to more than one package leaflet tested for readability (i.e. refer to one package leaflet related to content and to the other package leaflet related to design/layout).

In addition to bridging report, the following appendices should be attached:

• real size mock-up of "Parent” package leaflet used for comparing the design/layout
• real size mock-up of "Daughter” package leaflet
• "Parent” package leaflet used for comparing the content
• proof that readability of "Parent” package leaflet is tested with target patient groups and was positively assessed by National Competent Authority or EMA (i.e. PAR, EPAR)

It is not necessary to submit a complete report with the results of the readability testing, but only a confirmation from the Agency that carried out the assessment or a Public Assessment Report (PAR), from which it can be determined that a test with target groups of patients was conducted and positively evaluated.

Alongside the bridging report, it is possible to submit a report on focus-testing of readability of the package leaflet that can be carried out in case of a smaller number of important differences in the package leaflet content.