Change of content or termination of distribution of educational materials

With a view to assessment of the EM effectiveness, the MA holder may arrive at a conclusion that, according to their analysis, the information conveyed has been sufficiently incorporated in the current medical practice within the territory of the Czech Republic and that its further communication to doctors is no longer needed. With a view to this finding, the MA holder may ask SÚKL for EM content reduction or termination of EM distribution within the territory of the Czech Republic.

In case of medicinal products authorised solely via the national procedure, it is necessary to request that this obligation be lifted within the scope of submission of application for variation to marketing authorisation and submission of a RMP update. Where medicinal products authorised via MRP/DCP or centrally authorised medicinal products are concerned, SÚKL may authorise limited or suspended distribution solely within the territory of the Czech Republic. The application must be appropriately justified by the MA holder, providing the opinion of clinical experts from the field in question, or members of professional associations stating that the information has already been implemented in current medical recommendations (particularly the Czech Medical Association of Jan Evangelista Purkyně) or in textbooks. Furthermore, it is necessary to present evidence that doctors are aware of these facts and routinely adhere to these procedures (e.g. internal recommended therapeutic procedures at individual workplaces, absence of adverse drug reaction reports, evidence in reports and articles), or results of postauthorisation safety studies of EM effectiveness.

The application (except for the application for RMP variation requesting the lifting of the obligation to develop and distribute EM), together with any documentation, shall be submitted to the following address: farmakovigilance@sukl.cz. The subject of the e-mail message shall clearly state that this is an application for limited EM distribution and the name of the concerned medicinal product. It is advisable to discuss possible conditions and requirements on the part of SÚKL prior to the submission of the application. Applications for RMP variation requesting the lifting of the obligation to develop and distribute EM, together with any documentation, shall be submitted to the following address: posta@sukl.cz.

With regard to the obligation to assess the effectiveness, established by GVP, SÚKL may require that upon each update of EM for doctors carried out more than 5 years of the first distribution of the EM, the MA holder submit effectiveness evaluation and justify further need therefor in respect of each key element separately, taking into account particularly the following facts:

• the quantity and severity of adverse drug reaction reports relevant for the given risk within the territory of the Czech Republic;
• incorporation into clinical guidelines and recommended medical procedures applied within the territory of the Czech Republic;
• incorporation into approved procedures in specialised hospital centres (centres of biological treatment, transplantation centres, oncological centres, etc.);
• written opinion of experts from the field in questions on the up-to-datedness of the EM text;
• results of studies focused upon the assessment of EM effectiveness conducted within the territory of the EU with a special emphasis upon results (if available) from the Czech Republic.

In case that as a result of a variation to marketing authorisation (MRP/DCP + CAP), the obligation to implement further risk minimisation measures has been lifted, it is necessary to advise SÚKL´s Pharmacovigilance Department to this effect (farmakovigilance@sukl.cz) no later than within 1 month of approval of the variation to marketing authorisation.

In case the obligation to implement further risk minimisation measures is lifted or significantly changed in respect of centrally authorised medicinal products, such measure shall be applied to any other medicinal products with identical EM (identical active substance/combination of active substances, identical or similar risks), unless SÚKL requests otherwise. The concerned MA holders shall be advised to this effect by e-mail sent to the contact addresses of qualified persons for pharmacovigilance provided to SÚKL by the MA holder.