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02:36:312025-09-29

Electronic transmission of suspected adverse reactions of medicinal products for human use

AEMPS HEADQUARTERS > Procedures > Medicinal products for human use > Electronic transmission of suspected adverse reactions of medicinal products for human use

According to RD 577/2013, marketing authorisation holders (TACs) must send electronically to the EudraVigilance database:

  • All suspected serious adverse reactions occurring in the European Union and in third countries within 15 calendar days of the day on which you became aware of them.
  • All suspected non-serious adverse reactions occurring in the European Union in the ninety calendar days following the day on which you became aware of them.

This obligation applies from the six-month period following the date on which the functionalities of the EudraVigilance database were established, i.e. from 22 November 2017.

Recording, training and transmission of suspected adverse reactions to the EudraVigilance database

For further information on the recording, training and transmission of suspected adverse reactions to the EudraVigilance database, please refer to the EudraVigilance Database.EMA website.

Additional information on the electronic transmission of suspected adverse reactions
  • Question and Answer Documenton the transition to the flow through EudraVigilance of reporting suspected adverse reactions in Pharmacovigilance of Medicinal Products for Human Use.
  • CCAA table and INE codes:Información adicional a la Guía de Eudravigilance para el procesamiento de casos de sospechas de reacciones adversas (ICSR): EU Individual Case Safety Report (ICSR) Implementation Guide. Nota 8 Spanish and Italian Reporter’s State Codes y I.D.5 Reporter’s State codes for Spanish and Italian ICSRs.

The CCAA (Autonomous Community) field (Reporter’s State or Province (ICH E2B(R3) C.2.r.2.5) expects data from the column titled CODE_CCAA (2-digit code) and the Population field (Reporter’s Postcode ICH E2B(R3) C.2.r.2.6) expects data from the column titled CODE_INE_POPULATION (6-digit code).

In cases where the CCAA field (Reporter’s State or Province (ICH E2B(R3) C.2.r.2.5) and Population (Reporter’s Postcode ICH E2B(R3) C.2.r.2.6) in a primary source contain information, the population INE code must be consistent with the Autonomous Community code (e.g. reportersate = 09 (Catalonia) and reporterpostcode = 080193 (Barcelona) OK).

The field Reporter’s State or Province (ICH E2B(R3) C.2.r.2.5, expects data from the column entitled CODIGO_CCAA (2 digit code) and the field Reporter’s Postcode ICH E2B(R3) C.2.r.2.6 expects data from the column entitled CODIGO_INE_POBLACION (6 digit code). When both data elements Reporter’s State or Province (ICH E2B(R3) C.2.r.2.5 and Reporter’s Postcode ICH E2B(R3) C.2.r.2.6 are populated for a primary source, the INE code should match with the Autonomous Community code (eg: reportersate = 09 (Cataluña) y reporterpostcode = 080193 (Barcelona).

For the reporting of suspected serious adverse reactions by promoters of observational studies on medicinal products for human use, not TACs or TAC-funded medicinal products, you should refer to theInstructions for electronic transmissionof suspected adverse reactions directed at promoters of observational studies with medicinal products for human use, not marketing authorisation holders.

Contact

fvicsr@aemps.es

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