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 4, October 2019)
These instructions should be read along with the following guidelines:
- "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
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, 90/14 and 100/18), 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, 28/20 and 32/21), 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 "Creation of a 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:
- in the marketing authorisation procedure
- it is not separately charged, but included in the price of marketing authorisation
- 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):
- 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
- Results of all readability testing of the package leaflet and/or focus-testing and/or all bridging reports
- Other documentation in accordance with these instructions (if applicable)
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.
Creation of a bridging report
The bridging report should be prepared on the "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.
Please note that the "QRD form for submission and assessment of user testing bridging submissions" must be submitted in word format (as a working document).
