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 2, February 2016)

These instructions should be read along with the following guidelines:

Under Article 98 of the Medicinal Products Act (Official Gazette No. 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 portal.

The results of readability testing of the package leaflet represent an obligatory part of documentation for receiving marketing authorisation. Additionally, readability and simplicity testing of the package leaflet are also mandatory for medicinal products authorised before the accession of the Republic of Croatia to the European Union. HALMED hereby enourages marketing authorisation holders to fulfil this obligation as soon as possible.

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.

When readability testing is carried out in foreign language, the applicant/marketing authorisation holder is obliged to ensure a high-quality translation of the package leaflet to the Croatian language.

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. 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
  2. along with the dossier upgrading application as a variation that may be included in the dossier upgrading application (case 1.3.2.2.a Instructions for submission of applications for dossier upgrading, from 19 November 2012)
    • it is not separately charged, but included in the dossier upgrading price
  3. in the marketing authorisation procedure
    • it is not separately charged, but included in the price of marketing authorisation

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 indicating changes in the final
  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)

For medicinal products under Ordinance on special conditions for granting marketing authorisation in the Republic of Croatia for medicinal products authorised in the European Union (Official Gazette, No. 10/08), HALMED accepts the readability assessment carried out by the reference member state, provided that all testing results of the package leaflet and/or focus-testing and/or all bridging reports submitted to HALMED and that completed readability testing is applicable to the package leaflet from the Republic of Croatia, which should be supported by a written statement. If an applicant/marketing authorisation holder is not in possibility to confirm the aforementioned, it is necessary to proceed as above under I. - III. by submitting the appropriate documentation in accordance with these instructions.

For all other cases, the documentation for readability testing of the package leaflet should be delivered in accordance with these instructions.

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 "Consultation with Target Patient Groups", CMDh and additionally below:

  1. Referring a generic medicinal product package leaflet to a reference medicinal product package leaflet
    The referring is possible only if publically available data exist that that an acceptable readability testing of the package leaflet is carried out (i.e. publically available report about the assessment of the reference medicinal product dossier authorised via centralised procedure). In this case the content of both leaflets (except the one referred to specific data about the marketing authorisation holder/manufacturer etc.) should be equal.

    The bridging report in this case among others, should contain the following:
    • the name of the medicinal product and the procedure number of the reference medicinal product with the accepted readability testing,
    • proof of a successful completed/positively evaluated readability testing of the reference medicine package leaflet (i.e. copy of the publically available report about the product documentation),
    • proof that the text of the package leaflet that is being referred is equal (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 (if the presentation of the package leaflet of the generic medicine differs from the reference medicine package leaflet).
  2. Referring between different marketing authorisation holders/applicants
    Even though every applicant/marketing authorisation holder should have proper data about the readability testing of the package leaflet, it is possible that one applicant prepares the same package leaflet as other applicant that carried out the readability testing. In this case the content of the two package leaflets (with the exception related to specific data about the marketing authorisation holder/manufacturer etc.) should be equal, or similar enough for the preparation of a bridging report. Also, the presentation of the two leaflets must in all important parameters be the same or a bridging report carried out on the proper readability testing of the other package leaflet with the same presentation should be provided.

    Necessary documentation:
    • Statement by which the applicant that refers to another package leaflet confirms that he checked the readability results of the package leaflet of another applicant to which he refers and confirms that this testing is applicable to the package leaflet he prepared, or if the statement cannot be given a bridging report should be prepared concerning the package leaflet readability testing of another marketing authorisation holder.
    • Written consent about the right o use the results of readability testing of the package leaflet for another applicant ("letter of access") based on which the applicant that carried out the readability testing of the package leaflet allows the use of his data for the purpose of package leaflet preparation for another applicant.
    • Results of the readability testing (it is possible to refer to HALMED to previously submitted results or submit them with the application).
    If more applicants/marketing authorisation holders associate in order to commonly test the package leaflet readability for medicinal products containing same active substances, every one of them may use the results of common testing for preparation of the package leaflet.
  3. Referring to readability results of the package leaflet carried out for the purpose of obtaining marketing authorisation in another EU/EEA member state for the same medicinal product of the same marketing authorisation holder that follow a national procedure in the Republic of Croatia

    Necessary documentation:
    • Results of all readability testing of the package leaflet and/or focus-testing and/or all bridging reports for the equivalent 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 in certain EU/EEA member state.
    • In case the text of the package leaflet from the Republic of Croatia has the same content and presentation as the package leaflet authorised in an EU/EEA member state, the applicant submits the statement in which he certifies that the completed testing is applicable to the package leaflet authorised in the Republic of Croatia. If not, a bridging report should be prepared, that, among others, must contain a parallel comparison of the texts and presentations of both package leaflets, including mock-up, or, if necessary, provide results of an additional readability testing or focus-testing.
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