Regulatory information – Companies now required to update, complete and improve quality of information on authorised medicines submitted to the European Medicines Agency

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16/06/2014

Regulatory information – Companies now required to update, complete and improve quality of information on authorised medicines submitted to the European Medicines Agency

From today, the European Medicines Agency requires marketing-authorisation holders to update the information on authorised 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 authorisation;
  • a description of the medicinal product type based on controlled vocabularies;
  • information on the authorised pharmaceutical form and before reconstitution into the ‘administered’ pharmaceutical form;
  • a description of the size of the marketing-authorisation-holder company.

From today, 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, this database is expected to simplify adverse reaction reporting for marketing-authorisation holders and ensure that fees are calculated accurately.

Since January 2014, the Agency has been releasing guidance documents to support marketing-authorisation 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 today concerning the splitting of the full presentation names and substance names best practice.

In addition to completing previously submitted information, marketing-authorisation holders need to continue to submit information on new marketing authorisations within 15 calendar days from the date of notification of the granting of the marketing authorisation 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 by emailing art57submissionplan@ema.europa.eu 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 (IWG). The Group 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 authorisations for medicines in the European Union (EU) must submit information to the European Medicines Agency on all medicines authorised for use in the EU and keep this information up-to-date. This includes:

  • nationally authorised medicinal products (NAPs);
  • centrally authorised medicinal products (CAPs);
  • mutually recognised medicinal products (MRPs);
  • decentrally authorised medicinal products (DCPs).

Marketing-authorisation holders are also required to submit to the Agency information on all medicines for which they hold a marketing authorisation 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 2 July 2012. Since July 2012, marketing-authorisation holders have also had to submit information on new marketing authorisations granted after 2 July 2012.

Full details on the data-submission requirements are available on this website:

 


Note

  • Micro-, small and medium sized enterprises (SMEs) are advised to contact the Agency’s SME office regarding how to describe the company’s size.

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