The reporting of side effects /ICSRs/ is regulated by the EU announcement of 26/2004 ,EU Regulation No. 2001/83 / EC Directive and EUDRALEX Volume 9A. The procedure applies to adverse events, product problems and customer complaints reporting. The announcements quality control SOP / H / 3194 c. provides operational instructions.
As described above, the marketing authorization holder (MAH), or financing of a clinical trial must be registered in the EMEA EudraVigilance side with notification, data may fulfill their obligation.
The following required documents to electronic copies and signed registration at EUDRAVIGILANCE:
- Online registration form, signed by QP MAH organization representing the official agent.
- Cover letter signed by an authorized official representing Pharmacovigilance (QPPV) on company letterhead.
- Identity document of QPPV.
- User contact information statement (each user, including a QPPV as well).
- The court registration.
- Eudravigilance XEVMPD or user certificates issued by the EMEA • the name used in the primary designated in the registration system.
MedDRA license can be obtained at the MSSO site.
EudraVigilance website contains more information about the registration process of MAH and users.
Depending on the tasks Pharmacovigilance regulatory approval for the product approval stage prior to or after the official affected by the EudraVigilance operates two subsystems:
- EudraVigilance Clinical Trial Module (EVCTM) Suspected Unexpected Serious Adverse Reactions of (SUSAR) upon notification in accordance with the 2001/20/EC instructions
- EudraVigilance Post-Authorisation Module (EVPM) of Individual Case Safety Reports (ICSRs) to report to the (EC) No 726/2004 and 2001/83/EC, following the instructions contained in Volume 9A volume keys.
- You must obtain a EudraCT number from EUDRACT for any clinical trial, which was launched in May 2004 after the first COMMUNITY-e
- A plan should be provided about how the company will introduce the electronic reporting of ICSRs, the Agency and national authority. [The plan must be submitted to the EMA Ms Sabine Brosch (email@example.com) or Mr. Maignan Francois (firstname.lastname@example.org) for, Sector Pharmacovigilance and Post-Authorisation Safety and Efficacy, 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom address.]
- Other tasks brief summary of the Agency's website.
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