Information to marketing authorisation holders about the beginning of the using of of the new list of serious adverse reactions


The Agency of Medicinal products and Medical Devices (HALMED) started from May 8, 2011 using the new version of the list of serious adverse reactions (ADRs) for coding of ADRs and posted it on its web site. The list of serious ADRs has been updated and harmonised with the newest version of the IME (Important medical events) list. The new version of the IME list that is based on the version of the 15.0 MedDRA dictionary, was published in March this year.

Marketing authorisation holders are required to start using the new list when coding ADRs within 15 days from its publication (at the latest from May 23, 2012). The list is available on the HALMED website, under the link Pharmacovigilance (Croatian website) - List of serious ADRs.

In order to harmonise the reporting of certain serious ADRs and in accordance with the Art 66 of the Ordinance on Pharmacovigilance (Official gazette Nr 125/09), HALMED is publishing the list of ADRs that are considered serious and that are not defined by the seriousness criteria referred to in Articles 3 and 4 of the Ordinance on Pharmacovigilance.

The list of serous ADRs coded in MedDRA that HALMED is publishing is based on the CIOMS V Working Group's list of seriouss ADRs and the EMA's list on serious ADRs based on the IME list issued by MSSO. These ADRs are categorised as "medical serious conditions".

Every ADR listed, has at the PT level one of the label (seriousness criteria):

  • IME list - ADRs that according to the IME list always need to be coded as serious (CS="core serious")
  • CIOMS V - ADRs that according to the CIOMS V Working Group also need to be always coded as serious.

The novelty related to the IME list is that it, according to the decision of the EudraVigilance Expert Working Group (EV-EWG), do not anymore contain notions labeled as ES = "extended serious".

The marketing authorisation holder is required to record as serious any of the ADRs from this list occuring in the Republic of Croatia and report them to HALMED, accordingly.