EMA Updates Information Requirements for Marketing Authorizations

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-17-2014 11:33


Starting June 16, 2014, the European Medicines Agency now requires marketing-authorization holders to update the information on authorized medicines that they have submitted in accordance with Article 57(2) of the 2010 pharmacovigilance legislation.

This includes completing previously submitted information with additional data elements included in the new data-submission format, bringing medicine information up–to-date, and checking that the quality of the information is in line with the updated reporting requirements. Companies need to complete this process by the end of 2014.The additional elements that are now required include:

  • the details of the legal basis of the marketing authorization;
  • a description of the medicinal product type based on controlled vocabularies;
  • information on the authorized pharmaceutical form and before reconstitution into the ‘administered’ pharmaceutical form;
  • a description of the size of the marketing-authorization-holder company.

The data-submission system will only accept submissions that are in line with the updated data-submission format. From July 2014, the agency is planning to begin a systematic review of the quality and integrity of the information submitted to ensure that it is accurate and up-to-date.

This information on medicines is being used to support pharmacovigilance data analysis, to facilitate medicines regulation and fulfil regulatory actions and legal obligations, and to strengthen communication with the agency’s stakeholders and partners. By streamlining the identification of products relevant to pharmacovigilance procedures, EMA says this database is expected to simplify adverse- reaction reporting for marketing-authorization holders and ensure that fees are calculated accurately.

Since January 2014, the EMA has been releasing guidance documents to support marketing-authorization holders in these tasks. These include updates to the legal notice, detailed technical guidance, a data quality-control methodology, and controlled vocabularies.The agency has also published two new guidance documents concerning the splitting of the full presentation names and substance names best practice.

In addition to completing previously submitted information, marketing-authorization holders need to continue to submit information on new marketing authorizations within 15 calendar days from the date of notification of the granting of the marketing authorization by a regulatory authority. If companies using the EudraVigilance Gateway to submit, data cannot provide this information within this timeframe because of the schema changes, they should inform the agency of their expected submission plan and provide their name, headquarter ID, volume of data, and timeline for submission.

The agency has been working closely with representatives of European pharmaceutical-industry associations on the development of these measures through the Joint Implementation Working Group, which has endorsed all of the aspects related to the planning of and guidance on the data-maintenance submission process.

In line with Article 57(2) of the 2010 pharmacovigilance legislation, all holders of marketing authorizations for medicines in the European Union (EU) must submit information to the EMA on all medicines authorized for use in the EU and keep this information up-to-date. This includes:

  • nationally authorized medicinal products (NAPs);
  • centrally authorized medicinal products (CAPs);
  • mutually recognized medicinal products (MRPs);
  • decentrally authorized medicinal products (DCPs).

Marketing authorization holders are also required to submit to the EMA information on all medicines for which they hold a marketing authorization in European Economic Area (EEA) countries outside the EU (i.e. Iceland, Liechtenstein and Norway) since the pharmacovigilance legislation has been incorporated into the EEA agreement.

Marketing-authorisation holders were initially required to submit information on all human medicines authorised in the EU by July 2, 2012. Since July 2012, marketing-authorization holders have also had to submit information on new marketing authorizations granted after July 2, 2012.

Source: EMA


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