The reporting of adverse reactions and individual case safety reports (ICSRs) is governed by Regulation (EC) No. 726/2004, Directive 2001/83/EC, and Volume 9A of EUDRALEX. The procedure applies to the reporting of adverse events, product quality problems, and customer complaints. The quality control announcement and SOP / H / 3194 c. provide operational instructions.

As described above, the marketing authorization holder (MAH), or the sponsor of a clinical trial, must be registered with the EMEA EudraVigilance system in order to fulfill its reporting obligations.

The following documents are required for electronic registration with EUDRAVIGILANCE:

• An online registration form signed by the Qualified Person (QP) or the official representative of the MAH organization.
• A cover letter signed by an authorized official representing the Qualified Person for Pharmacovigilance (QPPV), on company letterhead.
• An identity document for the QPPV.
• A statement containing the contact details of each user, including the QPPV.
• The company registration document.
• EudraVigilance XEVMPD or user certificates issued by the EMEA, including the name used in the registration system.

A MedDRA license can be obtained from the MSSO website.

The EudraVigilance website contains further information about the registration process for MAHs and users.

Depending on the tasks and the stage of the product approval process, EudraVigilance operates two subsystems for pharmacovigilance reporting:

• The EudraVigilance Clinical Trial Module (EVCTM), for reporting Suspected Unexpected Serious Adverse Reactions (SUSARs) in accordance with the requirements of Directive 2001/20/EC.
• The EudraVigilance Post-Authorisation Module (EVPM), for reporting Individual Case Safety Reports (ICSRs) in accordance with Regulation (EC) No. 726/2004 and Directive 2001/83/EC, following the instructions contained in Volume 9A.

Pharmacovigilance notifications and preparations required before clinical trials and regulatory approval include:

• A EudraCT number must be obtained from EUDRACT for every clinical trial launched after May 2004 under the relevant European Community requirements.
• The company must prepare a plan describing how it will implement the electronic reporting of ICSRs to the Agency and the national authority. The plan must be submitted to the EMA at the following address: Sector Pharmacovigilance and Post-Authorisation Safety and Efficacy, 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom .
• Further tasks are summarized on the Agency's website.

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