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null What information on the patient or the reporter shall be submitted to the EudraVigilance database?

What information on the patient or the reporter shall be submitted to the EudraVigilance database?

All the information on the patient or the reporter that is available and can be entered into the EudraVigilance database shall be submitted.

The details provided on an adverse drug reaction (ADR) report are confidential. They include personal data on the reporter and the patient. The disclosure of information and content of a report are based on a specific legal provision.

According to Section 30e(1) of the Medicines Act (395/1987), the marketing authorisation holder, parallel import authorisation holder or registration holder shall, as a guarantee of pharmacovigilance and patient safety on the part of the register holder, record in the ADR database all the necessary details concerning  both identified and suspected adverse reactions, the medical conditions of the user of the medicine or his or her propensity to them, all medications, their therapeutic indications, adverse reactions to medicines, and the information required to identify the user of the medicine, such as name and personal ID. Under the same section, the register holder shall report to Fimea this information contained in the register.

Based on the EU pharmacovigilance legislation the obligation to report to Fimea has now expired and been replaced by the obligation to report to the EudraVigilance database. There are no EU provisions on the precise content of an adverse reaction report. National provisions therefore apply.

What is provided in Section 30e of the medicines Act concerning the content of an ADR report shall also apply when reporting to the EudraVigilance database. Section 30e of the Medicines Act does not lay down any restrictions as regards the disclosure of information identifying the patient or the reporter. There are no restrictions either in the other provisions in the Medicines Act concerning ADR reporting.
24 Jan 2018