2. Where should the application be submitted and what should it contain?
Please send the documentation of risk minimisation tools or programs to the email address of the Pharmacovigilance Division, firstname.lastname@example.org, for fast and efficient management. If the size of the documentation exceeds limits allowed to be sent as email attachments, then it can be submitted in appropriate format (e.g. CD, DVD) to the central registration office of the OGYÉI. Nevertheless, an email notification on the submission should still be sent to email@example.com. When the application is submitted completely via email, please do not submit it simultaneously to the central registration office, as this would result in the emergence of duplicate applications. The identification number 3007 should be indicated in the submission (also, in the subject of the email). A short cover letter should also be included indicating whether it is a first version or an update of an existing tool or program. In the latter case, please indicate whether it is a safety specific (concerning key elements) or an administrative update (please also refer to Question (Q) 7).
The application should contain the following documentation:
· Draft wording of the risk minimisation materials in Hungarian (in word format) and in English (in any format except when assessment is required – in this case a word document is needed). Font size should be easily readable. These requirements are valid for all type of materials, independent of the final format or layout (e.g. brochure, video, website, presentation, etc.).
· Approved product information that serve as reference for the risk minimisation materials.
· The communication plan, including
o a timetable of the implementation of the risk minimisation tool or program (e.g. planned distribution date, time of redistribution, first date of evaluation of effectiveness)
o the target group of healthcare professionals
o the method of dissemination.
· Information on the regulatory procedure in which the obligation was imposed (e.g. CMDh position, EC decision, documents of MR/DC procedures, reference to decision of the national competent authority, etc.). A formal closure document should be attached and the identification number of the procedure indicated.
· Items of the risk minimisation program and approved key elements. Please copy these entities from the approved risk management plan or assessment report, with appropriate reference to the source document, and paste them into a separate document.
· Mock-up of the risk minimisation tools. This could be a Hungarian or an English mock-up, or a collection of graphical/visual entities (e.g. tables, illustrations, logos) which are planned to be used on the final materials. In the latter case, please indicate the planned place of the entities in the document.
· In case of an update request, please indicate the reason for update, whether it concerns key elements or not, and include track changes versions of the relevant documents (Hungarian text, English text, approved product information, items of the risk minimisation program and key elements).
· The draft layout of the envelope or subject and text of email whichever is applicable for dissemination.
· Indicate whether the medicine is marketed in Hungary, or the planned launch date of the product.
· Information on cooperation of MAHs, if more MAHs are concerned.
· Draft plan for the measurement of effectiveness of the risk minimisation program, if any studies will take place in Hungary, or the medicine is only authorised in Hungary.
· Name and contact details of the person responsible for correspondence.
If the submitted documentation is incomplete, i.e. it does not contain any of the above listed documents or piece of information, the application is invalid, and the approval procedure cannot start. You can download the requirements in the form of a checklist by clicking here.
Please note that OGYÉI does not assess or approve the national implementation of risk minimisation measures that are pending or are still under discussion. Obligations should originate from closed regulatory procedures and this should be confirmed by the MAH by submitting the appropriate closure documents. In case of pending issues, position of OGYÉI may be obtained in prior consultation in the frame of a scientific advice procedure (please refer to Q1).