ENG Home Company Services News Reserved Area Contacts Links Regulatory Affairs Pharmacovigilance Market access solutions Training News Adaptation of the package leaflet of nationally authorized medicinal products The Evaluation and Authorization Office of the Italian Medicines Agency has recognized the need for companies, by 1 July 2015 , to adapt the structure of the package leaflet of medicinal products authorized with the national procedure to the QRD format (Working Group on Quality Review of Documents ), in compliance with the criteria defined in the European legislation in order to ensure its readability, clarity and easy use. In fact, the obligation to have a '' readable '' leaflet had already been transposed into our legal system by Decree 219/2006 which represents the implementation, also in Italy, of the Community code presented in Directive 2001/83 / EC. Title V, in fact, `` Labeling and Information Leaflet '' requires that the package leaflet reflect the result of investigations on targeted groups of patients, in order to ensure that the information contained therein is easily legible, clearly understandable and indelible, such to allow the patient to use the medicine correctly. However, until the AIFA press release issued last July, the Italian regulatory authority had not expressed itself on the methods of execution or on the deadlines of this obligation for purely national products. Now, however, it will be necessary to adapt all product sheets registered with the national procedure that are not already in QRD format (Quality Review Document template), simultaneously carrying out the relative readability test conducted in accordance with the criteria defined in the Lines European Corresponding Guide (Guideline on the readability of the labeling and package leaflet of medicinal products for human use). The results of the readability test will be entered in form 1.3.4. For medicinal products authorized with national procedure, it will be necessary to submit the readability test or alternatively a reasoned justification for the non-submission of this test, by 1 July 2015 through a variation specifically requested by AIFA, type IB - CIz "Submission of results of assessments carried out on target patient groups in order to comply with Article 59 (3) of Directive 2001/83 / EC and any resulting change to the Package Leaflet "- for the update of module 1.3.4. The adaptation of the relevant leaflet to the QRD format will be assessed at the same time, upon declaration that the information contained in the leaflet complies with the authorized summary of product characteristics (SmPC). Any justification for not submitting the readability test, or submitting a bridging report must be based exclusively on the exemption criteria defined by the European guidance documents, published on the CMDh portal, as explicitly requested by AIFA (http: // www. hma.eu/cmdh.html (CMDh / 100/2007; FAQ on Product Information). Once the package leaflet has been adapted to the QRD format, in the manner detailed above, it must be kept updated to the latest published version of the QRD format, implementing updates as soon as possible and in any case, as per the recommendation of the CMDh, no later than two years after the publication of the new QRD format itself. The update can be made in the first useful variation that includes a change to the printed matter (eg change of indications, dosage or safety information), explicitly declaring it in the Application Form. commerce or line extensions submitted with national procedure, starting from 1 January 2014the relative dossiers must contain form 1.3.4 complete with the readability test or a reasoned justification for the failure to submit this test. The proposed leaflet must then be completed in QRD format. For requests for a new marketing authorization or line extension submitted with a national procedure still under evaluation, companies, before the conclusion of the relevant procedure, can update form 1.3.4 of the dossier filed by submitting the readability or a reasoned justification for the failure to submit this test together with the proposed leaflet in QRD format. Alternatively, the MA holder can request that the procedure be concluded without the above update, with the commitment to submit the request by 1 July 2015 through a variation of type IB (CIz). For more information contact us at the following address: infotemas@quintiles.com Temas Srl Cassina Plaza Building F, staircase 2 Via Roma, 108 20060 - Cassina De 'Pecchi Milan, Italy Tel: +39 02 95794 1 Fax: +39 02 95794 435 infotemas@quintiles.com Visit the website www.quintiles.com