Individual case safety reports (ICSRs)

Individual Case Safety Report (ISCR) is a document providing the most complete information related to an individual case at a certain point of time. ICSRs, sometimes referred to as safety reports, are used for reporting suspected adverse reactions to the EudraVigilance database. to a medicinal product that occur in a single patient at a specific point in time

An indicvidual case is the information provided by a primary source to describe suspected adverse reactions/suspected unexpected serious adverse reactions related to the administration of one or more medicinal products/investigational medicinal products to an individual patient at a particular point of time.

General reporting requirements of ICSRs

During the interim period, in accordance with the transitional provisions set out in Article 2(4) and Article 2(5) of Directive 2010/84/EU,

Until the Agency can ensure the functionalities of the Eudravigilance database as specified in Article 24 of Regulation (EC) No 726/2004 as amended by Regulation (EU) No 1235/2010 ( 1 ) of the European Parliament and of the Council, marketing authorisation holders shall report, within 15 days of the day on which the holder concerned gained knowledge of the event, all serious suspected adverse reactions that occur in the Union, to the competent authority of the Member State on whose territory the incident occurred and shall report all serious suspected adverse reactions that occur on the territory of a third country to the Agency and, if requested, to the competent authorities of the Member States in which the medicinal product is authorised.

Until the Agency can ensure the functionalities of the Eudravigilance database as specified in Article 24 of Regulation (EC) No 726/2004 as amended by Regulation (EU) No 1235/2010, the competent authority of a Member State may require marketing authorisation holders to report to it all non- serious suspected adverse reactions that occur on the territory of that Member State, within 90 days of the day on which the marketing authorisation holder concerned gained knowledge of the event.

the reporting requirements detailed in Table 1 shall apply to valid ICSRs reported by healthcare professionals and non-healthcare professionals.

This is irrespective of the conditions of use of the suspected medicinal products and of the expectedness of the adverse reactions.

Reporting requirements applicable to marketing-authorisation holders - Interim period

Marketing authorisation procedureOriginAdverse reaction typeDestinationTime frame
EUAll serious
  • Member State where suspected adverse reaction occurred (a)
15 days
All non-serious
  • Member State where suspected adverse reaction occurred, if required (b)
90 days
Non-EUAll serious15 days

(a) Member States may request marketing authorisation holders to report serious EU ICSRs originating in their territory to them and/or to EudraVigilance. Those requirements are detailed in Table 2.

(b) Member States' reporting requirements during the interim period for non-serious EU ICSRs and for serious non-EU ICSRs are presented respectively in Table 3 and 4.

Serious ICSRs originating in the territory of a Member State

Reporting requirements applicable to marketing authorisation holders – Interim period –

Marketing authorisation procedureOriginAdverse reaction type

Destination

EU

All serious

Member State where suspected adverse reaction occurred:

AT, CZ, DE, DK, ES, FI, HR, IE, IT, LT, LV, NO, PT, RO, SI, SK, UK.

EudraVigilance:

BE, CY, EE, FR1, GR, IS, LI, LU, MT, NL, PL, SE.

Member State where suspected adverse reaction occurred and EudraVigilance:

BG, HU.

FR1: Marketing authorisation holders already submitting ICSRs directly to France can continue to do so during the interim period (France retransmits these ICSRs to EudraVigilance), or can switch to direct transmission to EudraVigilance.

Member States' requirements for non-serious EU ICSRs

Table 3 Reporting requirements applicable to marketing authorisation holders – Interim period – Member States' requirements for non-serious EU ICSRs

Marketing-authorisation procedureMember states who wish to receive non-serious ICSRs of suspected adverse reactions occurring in their territory
AT1, DE2, DK, HR, IT3, PL, RO.

AT1: Only for non-serious ICSRs related (i) to vaccines or plasma preparations (Verordnung betreffend Identifizierungserfordernisse für bestimmte Arzneispezialitäten), or (ii) to those medicinal products which are included in the list of products subject to additional monitoring pursuant to Art. 23 of Regulation (EC) No 726/2004.

DE2: Only for non-serious ICSRs related to vaccines reportable to the Paul-Ehrlich-Institut. Reporting of other non-serious ICSRs related to non-vaccines medicinal products will only be requested individually in case of safety concerns.

IT3: Not required for non-serious ICSRs published in the scientific and medical literature.

Table 4: Reporting requirements applicable to marketing authorisation holders – Interim period – Member States' requirements for serious non-EU ICSRs

Marketing authorisation procedureMember States who wish to receive non-EU serious ICSRs of adverse reactions suspected to be related to a medicinal product authorised in their territory
DE, UK1.

UK1: Only for healthcare professional serious non-EU ICSRs.

Reporting requirements of literature reports

Literature reports are defined in GVP Module VI, chapter VI.B.1.1.2.

To enhance the efficiency of reporting and to provide a simplification for pharmaceutical industry, Article 27 of Regulation (EC) No 726/2004 sets out the following:

  1. The Agency shall monitor selected medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances. It shall publish a list of active substances being monitored and the medical literature subject to this monitoring.
  2. The Agency shall enter into the EudraVigilance database relevant information from the selected medical literature.
  3. The Agency shall, in consultation with the Commission, Member States and interested parties, draw up a detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database.

The detailed guide, the list of active substances being monitored and the medical literature subject to the monitoring by the Agency are published at the dedicated medical literature monitoring webpage.

During the interim period outlined in Article 2(4) and Article 2(5) of Directive 2010/84/EU and in line with national legislation and guidance where applicable, the following therefore applies to valid ICSRs originating from the literature:

  1. For active substances and literature not subject to the medical literature monitoring conducted by the Agency pursuant to Article 27 of Regulation (EC) No 726/2004, the reporting modalities as outlined in Chapter 1 of this document apply.
  2. For active substances subject to the medical literature monitoring conducted by the Agency pursuant to Article 27 of Regulation (EC) No 726/2004 but when the publication containing the relevant information is not included in the list of publications monitored by the Agency, the reporting modalities as outlined in Chapter 1 of this document apply.
  3. For active substances subject to the medical literature monitoring conducted by the Agency and when the publication containing the relevant information is included in the list of publications monitored by the Agency pursuant to Article 27 of Regulation (EC) No 726/2004, the reporting modalities as outlined in Table 5 apply.

Table 5. Reporting requirements applicable to marketing-authorisation holders – Interim period – active substances and journals subject to the service of the Agency pursuant to Article 27 of Regulation (EU)

Marketing authorisation procedure – substances subject to the service of the Agency

Origin

Based on journals subject to the services of the Agency

Adverse reaction typeDestinationTime frame
EUAll serious2
  • DE1 when suspected adverse reaction occurred in this territory
15 days
All non-serious2
  • DE1 when suspected adverse reaction occurred in this territory but only if requested individually in case of safety concerns
90 days
Non-EUAll serious215 days

1Federal Institute for Drugs and Medical Devices (BfArM)

2 Valid ICSRs are submitted by the Agency to the applicable Member State in line with chapter 1 of this document and as outlined in the Detailed Guide[2].

[2]

How useful was this page?

Add your rating
Average
2 ratings