Medicinal Products

Instructions for marketing authorisation holders about readability and simplicity testing of the package leaflet

Instructions for marketing authorisation holders about readability and simplicity testing of the package leaflet
(Version 3, February 2018)

These instructions should be read along with the following guidelines:

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.

Under Article 98 of the Medicinal Products Act (Official Gazette Nos. 76/13 and 90/14), readability and simplicity of the package leaflet should be checked in target patient groups.
Under Article 82 of the Ordinance on the Marketing Authorisation of Medicinal Products (Official Gazette No. 83/13), 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.

Introduction to readability testing of the package leaflet

The package leaflet must be written in a way that is clear and understandable way 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. Readability of the package leaflet is tested in target patient groups under Article 59 (3) of the Directive 2001/83/EC and the above indicated guidelines.

Readability testing of the package leaflet may be carried out in any language of member states of the European union and/or European Economic Area (hereinafter EU/EEA), whereas testing results should be submitted to HALMED in English or Croatian.

In certain cases, HALMED may accept the preparation of a bridging report that is prepared by referring to a "similar" package leaflet tested for readability, which is described in detail in the segment "Reference to another package leaflet - preparation of bridging report". In this case no significant difference in the package leaflets that are being referred to, should exist. It is also recommended that their presentation 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 presentation).

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.

Submission procedure for readability testing of the package leaflet to HALMED

Data on the readability testing of the package leaflet, or on the bridging report, can be submitted by the applicant/marketing authorisation holder to HALMED in one of the following ways:

  1. in the marketing authorisation procedure
    • it is not separately charged, but included in the price of marketing authorisation
  2. by submitting a variation application under the current legislation in the Republic of Croatia
    • in the application form, in accordance with CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008, the type of variation is marked as IB C.I.z
    • the variation is charged according to the current price list

The documentation for readability testing of the package leaflet should be submitted in the variation procedure or dossier upgrading procedure for granting marketing authorisation (alongside the standard documentation for the aforementioned applications):

  1. Package leaflet proposal
    • 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 mark up version and in the final version
  2. Results of all readability testing of the package leaflet and/or focus-testing and/or all bridging reports
    • reports must be signed by the responsible person
  3. Other documentation in accordance with these instructions (if applicable)

Reference to another package leaflet - preparation of bridging report

The procedure of referring to another package leaflet and presentation and parts that the Bridging Report must contain are described in the guidelines and documents available here, and additionally below:

  1. Referring to a package leaflet with readability testing being carried out and accepted which is supported by publicly available data
    The referring is possible only if publicly available data exists that an acceptable readability testing of the package leaflet has been carried out (i.e. Public Assessment Report - PAR or European Public Assessment Report - EPAR). In this case the content of both leaflets (except the part referring to specific data about the marketing authorisation holder/manufacturer etc.) should be identical.

    Required documentation:
    • proof of a successful completed/positively evaluated readability testing of the reference medicine package leaflet (i.e. copy of the publicly available report about the product documentation)
    • proof that the text of the package leaflet that is being proposed in the Republic of Croatia is equal to the reference medicine package leaflet (parallel comparison of the content of two package leaflets should be provided)
    • bridging report on the completed proper readability testing of the other package leaflet with the same presentation, including mock-up (if the presentation of the package leaflet which is being proposed in the Republic of Croatia differs from the reference medicine package leaflet).

  2. Referring to readability results of the package leaflet carried out and approved in another EU/EEA member state

    Necessary documentation:
    • Results of all readability testing of the package leaflet and/or focus-testing and/or all bridging reports for the package leaflet in another EU/EEA member state.
    • Assessment of the readability testing results carried out by the competent authority or proof by the competent authority that it positively assessed the results (if available) or statement of the applicant/marketing authorisation holder that the results are accepted for approval or that the results are in the process of being accepted for approval in certain EU/EEA member state.
    • Written consent on the right to use the results of readability testing of the package leaflet for other applicant (letter of access) based on which the applicant/marketing authorisation holder which has conducted the readability testing of the package leaflet allows the use of its data in preparation of the package leaflet by other applicant/marketing authorisation holder. Document should be delivered if the applicants/marketing authorisation holders for the package leaflet approved in the EU/EEA and for the package leaflet proposed in the Republic of Croatia are not part of the same company/company group.
    • Bridging report, which, among others, must contain a parallel comparison of the texts and presentations of both package leaflets, including mock-up. In case of minor number of significant differences in content of the two package leaflets, it is possible to deliver the results of the additional readability testing of the package leaflet (focus-testing).

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