VI.C.4. Submission modalities of ICSRs in EU

In addition to the guidance provided in VI.B.8., the competent authority in a Member State and the marketing authorisation holder shall use the formats, standards and terminologies for the electronic submission of suspected adverse reactions as referred to in Chapter IV of the Commission Implementing Regulation (EU) No 520/2012. ICSRs shall be used for the submission to the EudraVigilance database of reports of suspected adverse reactions to a medicinal product that occur in a single patient at a specific point in time [IR Art 27]. The competent authority in a Member State and the marketing authorisation holder shall also ensure that all submitted ICSRs are well documented and as complete as possible in accordance with the requirements provided in Article 28 of the Commission Implementing Regulation (EU) No 520/2012. The time frames for submitting serious and non-serious valid ICSRs are provided in VI.C.3.

The guidance provided in VI.C.6. should be adhered to as regards the electronic exchange of pharmacovigilance information between competent authorities in Member States, marketing authorisation holders and the Agency.

In line with the provisions set out in Article 107(3) and 107a(4) of Directive 2001/83/EC, the following submission requirements shall apply to valid unsolicited and solicited ICSRs reported by healthcare professionals and non-healthcare professionals in relation to medicinal products for human use authorised in the EU in accordance with Directive 2001/83/EC and Regulation (EC) No 726/2004. This is relevant irrespective of the condition of use of the suspected medicinal product and of the expectedness of the adverse reaction.

a. Serious ICSRs

• The marketing authorisation holder shall submit all serious ICSRs that occur within or outside the EU, including those received from competent authorities outside the EU, to the EudraVigilance database only.
• The competent authority in a Member State shall submit to the EudraVigilance database all serious ICSRs that occur in its territory and that are directly reported by healthcare professionals or consumers.

b. Non-Serious ICSRs

• The marketing authorisation holder shall submit all non-serious ICSRs that occur in the EU to the EudraVigilance database only.
• The competent authority in a Member State shall submit to the EudraVigilance database all non-serious ICSRs that occur in its territory and that are directly reported by healthcare professionals or consumers.

Overviews of the submission requirements for serious and non-serious ICSRs applicable to marketing authorisation holders and competent authorities in Member States, together with a business process map and a process description, are presented in VI.App.3.1., VI.App.3.2. and VI.App.3.3.

In line with the requirement detailed in Article 24(4) of Regulation (EC) No 726/2004, the ICSRs submitted to the EudraVigilance database by a marketing authorisation holder shall be automatically transmitted upon receipt, to the competent authority of the Member State where the reaction occurred. When the primary source country and the country of occurrence of the reaction differ, the competent authorities of the concerned member states in the EU will be automatically notified about these specific ICSRs. A business process map and a process description concerning the automatic retransmission of ICSRs are included in VI.App.3.4.

In accordance with Article 24(2) of Regulation (EC) No 726/2004, the data submitted to the EudraVigilance database are made accessible to stakeholders such as competent authorities, healthcare professionals, consumers, as well as marketing authorisation holders and research institutions. Access is provided based on the latest version of the EudraVigilance Access Policy for Medicines for Human Use33. This policy defines the overall principles in relation to the provision of access to EudraVigilance data in line with the current legal framework, while guaranteeing personal data protection.

Additionally, the EudraVigilance database shall also be accessible to marketing authorisation holders to the extent necessary for them to comply with their pharmacovigilance obligations [REG Art 24(2)].

Further guidance on the access by stakeholders of the data submitted to the EudraVigilance database is available on the EudraVigilance webpage34 .