Approval of educational materials

With a view to the submitted source materials, SÚKL shall, within a reasonable timeline, provide its opinion on the content and methods of distribution for the EM. SÚKL is not responsible for the linguistic quality and up-todatedness of the materials. Once the content is approved, the MA holder shall send the proposed graphical representation of the materials in the PDF format. The final form of the EM is subject to agreement between the MA holder and SÚKL´s Pharmacovigilance Department.

Following EM approval, the MA holder shall send the approved final version, in its final graphical form, in the PDF format together with the exact date of distribution and approved Distribution Plan. Should the MA holder identify grammatical errors, they may correct them without having to have these corrections further approved.