H-1135 Budapest, Szabolcs utca 33.

Tel.: (1) 8869-300, General information: 1812

E-mail: info@egeszsegvonal.gov.hu

Mail: 1372 P.O. Box: 450.


Mellékhatás bejelentő
NOR keresőfelület Minőségi kifogás
magisztrális gyógyszerek

6. How can risk minimisation tools be distributed and should the dissemination be recorded?

The proposal for the method of dissemination is made by the applicant in the communication plan. The appropriateness of the method is assessed by the Pharmacovigilance Division which is done on a case-by-case basis, taking into account the proposed target groups and the features of the Hungarian healthcare system. Please consider the paragraphs below:

Dissemination should always be documented and its effectiveness should reach at least 75% (if possible, for every target group). The effectiveness of dissemination should be measured by the number of healthcare professionals who received the risk minimisation tool (and this can be proved) compared to the number of healthcare professionals to whom the risk minimisation tool was sent. If this ratio remains below 75%, the MAH should introduce corrective actions which may include resending the materials or using alternative ways of dissemination. Data on the effectiveness of dissemination should be submitted to OGYÉI within 2 months of starting dissemination. Various methods may be suitable for recording receipt of the material by the target group including recorded delivery, registered mails, asking for feedback in emails or other electronic methods, signature at personal delivery or following face to face training, etc.

Dissemination may be done electronically, via mail, using the service of the Hungarian Medical Chamber, personally, etc., provided that the target group is effectively reached by the chosen method in a documented way. More channels may be used simultaneously.

The risk minimisation tool should not be disseminated electronically, if it should be available as a hardcopy either for the patient or the physician (e.g. a checklist, dosing/measurement guide, patient card, etc.). When determining the number of printed copies and disseminating them, please consider sales data, patient exposure and/or the number of patients treated so that there are always enough copies available for the physician (e.g. patient cards or other materials to be handed over to the patients). It is the responsibility of the MAH to supply healthcare professionals and patients with a sufficient amount of risk minimisation materials.

Dissemination of risk minimisation tools should be accomplished in an appropriately marked envelop to distinguish them from other (promotional) content. Reference should be made that the envelope contains important guidance on the correct and safe use of the medicine. Please indicate on the envelope the following label: ‘Important risk minimisation guidance’. Draft of the envelope should also be submitted for approval. In case of electronic dissemination, the same principles apply to the subject and content of the email.

According to GVP Module XVI, risk minimisation tools should not be disseminated together with promotional materials, or in the frame of promotional activities.

Last updated: 2017.02.10 10:48