New EMA Pharmacovigilance Legislation 2012 – electronic submission of information

In July 2012, the new pharmacovigilance legislation will come into effect across the European Union, according Regulation (EU) No 1235/2010External link icon and Directive 2010/84/EUExternal link icon.

According EMA this legislation is the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It has significant implications for applicants and holders of European Union marketing authorisations. The European Medicines Agency is responsible for implementing much of the new legislation and is developing a framework for compliance and delivery of key requirements. The legislation is effective from July 2012.

Regulation 1235/2010 states that by 2 July 2012, marketing-authorisation holders will need to submit information to the Agency on medicinal products for human use authorised or registered in the EU using an electronic format provided by the Agency. Marketing-authorisation holders will also be responsible for maintaining this information once submitted. The European Medicines Agency is progressing with the implementation of the electronic submission of information on medicines (read more).

The Agency published the format for the electronic submission of medicinal product information in July 2011 as XML Schema Definition (XSD), submitted via the EudraVigilance GatewayExternal link icon. On 5 March 2012, the Agency published an update of the format, including detailed guidance, Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) messaging schemas, controlled vocabularies and frequently asked questions. The Agency maintains its plan to update the initial format published in July 2011 in line with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards. The IDMP standards are scheduled for finalisation during the second half of 2012.

comes compliance services (CCS) offers consultancy services for the implementation road-map and integration of e-reporting and submissions based on the regulatory requirements. Contact us today for more information and our service options related to e-reporting and submissions to the agency: