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Should adverse reactions, if applicable, be reported with the use of non-authorised medicinal products? If so, how should they be reported and to whom, and who will be responsible for the reporting?

In the case of an individual use of a non-authorised medicinal product, the report shall be submitted by the doctor who has decided about the administration of the product concerned. He/she shall forthwith report serious unexpected adverse drug reactions = SUADRs (where death or a life-threatening reaction is involved, the reporting shall be made within 7 days +8 days for supplementing the report; other SUADRs shall be reported within 15 days); furthermore, anything else, i.e. unexpected ADRs and serious expected adverse reactions as per the Package Leaflet or Summary of Product Characteristics shall be reported by the doctor to SÚKL, Department of Clinical Trials.   

Reporting methods:

  1. By completion of the CIOMS form and its sending, either by post or by mail (klinsekret@sukl_cz  or tomas.boran@sukl_cz ); or
  2. By completing the electronic form; it is necessary to insert the following information in the remark: – “product used in compliance with Section 8 of the Act on Pharmaceuticals”.