Submission of educational materials for approval

Proposed EM shall be sent by e-mail to the following address: farmakovigilance@sukl.cz.

The content of the e-mail with the proposed EM must include:

• the reason why the EM have been developed, including legislative source materials (decision of CHMP, CMDh, EU referral, change to SmPC, etc.) together with documents evidencing such change;
• the English original of the proposed EM (if it exists);
• the proposed EM in the Word format so as to be able to insert comments in the form of mark-ups;
• the text of the presentation in the Word format, if the EM assume the form of a presentation (e.g. PowerPoint);
• anticipated EM distribution date;
• draft Distribution Plan which shall specify the method of distribution, time schedule, distribution target groups, and the number of relevant healthcare professionals to whom the EM are to be distributed (for specimen Distribution Plan, please refer to the annex hereto).
  • Using a separate dated document called “Distribution Plan”, the applicant shall describe the proposed method, date, and scope of distribution (individual medical specialties, method of initial distribution, repeated Distribution Plan (timelines and method of redistribution, means of identifying further need for EM, etc.).
  • SÚKL may also request the distribution list of individual workplaces where distribution is to be carried out, including other additional details (such as the number of copies per workplace, number of doctors to whom EM is to be delivered, etc.). In compliance with the GDPR, SÚKL does not require itemised lists with the names of doctors or other healthcare professionals.

Before sending the e-mail with the proposed EM it is necessary to check whether the recommendations contained in the materials are applicable to the Czech medical practice.

The proposed EM should be provided to SÚKL for approval at least 2 months prior to the planned placement of the medicinal product onto the market or prior to the sending of updated EM for marketed medicinal products, unless stipulated otherwise (e.g. another time schedule). If it is necessary to prepare and distribute new EM for marketed medicinal products, their submission for approval shall be governed by the approved scheme of SÚKL or EMA on the basis of whose decision the obligation to develop and distribute EM has arisen.

Submission for approval is required also for the Patient Alert Card distributed in medicinal product packages whose Czech text has already been approved as part of the marketing authorisation procedure (this applies particularly to medicinal products authorised via centralised procedure), where, however, the format, appearance and possible distribution method are still subject to approval by SÚKL. Following assessment, SÚKL may request secondary distribution method of the Patient Alert Card via doctors, particularly in those cases where the patient does not come into direct contact with the medicinal product packaging (e.g. in case of medicinal products administered by infusion), and hence it is not adequately ensured that the patient will indeed get the Patient Alert Card.

For the purposes of a cover letter which is to be attached by the MA holder to the shipment or which is the subject of e-mail communication with the doctor or another healthcare professional, SÚKL has developed a template which forms an annex hereto and which may be used by the MA holder at their discretion. The purpose of the cover letter is the description of reasons why the EM has been developed and what its objectives are.

SÚKL considers the information contained in the EM public data intended to minimise risks which are not subject to the MA holder´s copyright. For this reason, the MA holder is advised not to include any data considered thereby to be copyright-protected or their business secret to the EM.

SÚKL requires that the materials be submitted for approval also in case where the MA holder is aware that the medicinal product may be reimbursed as per Section 16 of Act No 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts, or in those cases where the MA holder, in compliance with Section 3, paragraph 6(b) of Decree No 228/2008 Coll., on Marketing Authorisation of Medicinal Products, as amended, applies for the placement of individual batches of a medicinal product the labelling of which is not in the Czech language (so called foreign-language batch) onto the market.