DHPC und Educational Material Mag. Rudolf Schranz Medizinmarktaufsicht, Life Cycle Management, Regulatorische Angelegenheiten
DHPC / Educational Material Grundlagen I DHPC in GVP Module XV http://www.ema.europa.eu/docs/en_gb/document_library/scientific_guideline/2013/01/wc500137666.pdf Educational Material in GVP Module XVI http://www.ema.europa.eu/docs/en_gb/document_library/other/2015/04/wc500186217.pdf Seit Q4 2015 in Kraft Revision II ab 31.03.2017 in Kraft Addendum I http://www.ema.europa.eu/docs/en_gb/document_library/regulatory_and_procedural_guideline/2015/12/wc500198761.pdf
Direct Healthcare Professional Communication (DHPC)
Direct Healthcare Professional Communication Grundlagen I A DHPC should be disseminated in the following situations when there is a need to take immediate action or change current practice in relation to a medicinal product: suspension, withdrawal or revocation of a marketing authorisation for safety reasons an important change to the use of a medicine due to the restriction of an indication, a new contraindication, or a change in the recommended dose due to safety reasons a restriction in availability or discontinuation of a medicine with potential detrimental effects on patient care new major warnings or precautions for use in the product information
Direct Healthcare Professional Communication Grundlagen II new data identifying a previously unknown risk or a change in the frequency or severity of a known risk substantiated knowledge that the medicinal product is not as effective as previously considered new recommendations for preventing or treating adverse reactions or to avoid misuse or medication error with the medicinal product ongoing assessment of an important potential risk, for which data available at a particular point in time are insufficient to take regulatory action
DHPC Letter Unterlagen und Einreichung Notwendige Unterlagen: deutsche Übersetzung mit englischem Original (falls vorhanden) Zeitplan (vorgegeben durch Behörde oder firmenintern) Geplanter Verteiler (Angabe der Zielgruppen ausreichend) Per Mail bzw. via EudraLink (insbesondere bei großen Dateien) Postweg (Im Falle von Videos DVD und / oder USB Stick) Begutachtung erfolgt nach dem Datum der Einreichung (bzw. nach Versendedatum)
Effectiveness of safety communication In the case of DHPC, the MAH should be responsible for evaluating the dissemination inform the competent authorities of the outcome and of any difficulties identified (e.g. problems related to the list of recipients or the timing and mechanism of dissemination) Appropriate action should be taken as needed to correct the situation or prevent similar problems in the future
EDUCATIONAL MATERIAL
Educational Material Grundlagen I Need for educational materials may be agreed during a regulatory procedure, at the time of the initial marketing authorisation in the post-authorisation phase, e.g. after introduction of a new RMP or an update of an existing RMP Any educational material should be specifically designed to fulfil the risk minimisation objectives It should focus on the specific safety concern(s) and provide clear statements and concise messages describing actions to be taken in order to prevent and minimise these risks
Educational Material Grundlagen II The national versions of the educational material should only be submitted, by the marketing authorisation holder, following the conclusion of the regulatory procedure in which the armm was agreed Educational materials should be drafted in the official language Educational materials should not include or be combined with promotional elements either direct or veiled (e.g. suggestive images and pictures)
Educational Material Grundlagen III The methods for dissemination and the target audience are determined at national level by the competent authority Based on the respective target audience, the marketing authorisation holder should provide to the NCA a proposal for the educational material(s). The target population determines which tool, content, format, language type and readability level is appropriate for the educational material. Specific efforts in adaption should be made when targeting patients (see GVP Module XV) The NCA should review the respective national version of the educational material The MAH should disseminate the educational material only after approval by the NCA
Educational Material Grundlagen IV If the medicinal product is not placed on the market dissemination is not required. In any case, the need for dissemination of any educational material should be discussed with the NCA The MAH should exercise version control and ensure that only the latest agreed version of the educational material is disseminated. The date of approval by the competent authority the Member State should be included in the educational material, as reference for healthcare professionals and/or patients
Educational Material Grundlagen V Without prejudice to the originality of the format of the educational material, it is in the interest of public health that educational material used by different applicants/marketing authorisation holders for the same active substance should be kept as similar as possible, in order to deliver a consistent message and avoid confusion in the target audience. Therefore, marketing authorisation holders are strongly encouraged to share the content of their educational material(s) upon request from other marketing authorisation holders
Educational Material Zu beachten Wenn auf EU Ebene beschlossen Umsetzung verpflichtend Cover Letter (bes. bei umfangreichen Materialien) Schwarzes Dreieck Versionenkontrolle Keine Kombination mit Werbeunterlagen Firmenlogo nur einmal (auf der letzten Seite) - keine Markenlogos Finale Version im pdf Format an das BASG
Educational Material Inhalt Key elements as agreed at EU Level SmPC and/or PL may be part of Messages should be based on SmPC / PL and agreed key elements Images or graphic presentation text is not sufficient Scope should be limited to the key elements Additional information such as efficacy data, comparisons of safety with other medicinal GVP products or statements which imply that the medicine is well tolerated or that adverse reactions occur with a low frequency should not be included. Referring to other medicinal products outside the scope of the educational material is not allowed.
Educational Material Einreichung Per Mail bzw. via EudraLink (besonders bei großen Dateien) Per Post (vor allem DVD s bzw. USB Sticks) Notwendige Unterlagen: deutsche Übersetzung mit englischem Original (falls vorhanden) Geplanter Verteiler (Zielgruppen ausreichend) Zeitplan (vorgegeben durch Behörde oder firmenintern)! Keine Einreichung per CESP! Begutachtung erfolgt nach dem Datum der Einreichung (bzw. nach Versendedatum) Dauer der Begutachtung soll 60 Tage nicht übersteigen
Educational Material Website Access to the website should be given to the competent authority of the MS; A statement that the information of the website is consistent with the agreed material. The specific website should not include any reference to documents or to other websites/pages or weblinks not agreed with the competent authority. All elements and information on the specific website should be expressed in the official language or, in exceptional cases with the agreement of the competent authority in English The specific website should not contain references to or information about medicinal products not marketed in that MS. Other relevant documents such as the SmPC, the PL and the summary of the RMP may be referred to
DHPC / Educational Material Verteilmodus In Abhängigkeit vom Verteiler Gut definierter Verteiler (Post, E-Mail, Außendienst) Umfangreicher Verteiler (Post) Kontrolliertes Distributionssystem (Post, E-Mail, Außendienst, Großhandel) Auswahl des Verteilmodus ist eine Fall zu Fall Entscheidung Wichtig: Information zeitnah an die gesamte Zielgruppe
Mag. Rudolf Schranz Gutachter LCM /REGA BASG - Austrian Federal Office for Safety in Health Care Traisengasse 5 1200 Vienna T: +43 (0)50 555 36246 rudolf.schranz@ages.at www.basg.gv.at