European Medicines Agency announces next steps for the maintenance of information on medicines in accordance with mandatory Article 57(2) requirements

  • Email
  • Help

News

04/07/2012

European Medicines Agency announces next steps for the maintenance of information on medicines in accordance with mandatory Article 57(2) requirements

The European Medicines Agency is providing pharmaceutical companies with information on the next steps for the maintenance of information provided on human medicines in accordance with Article 57(2) of the 2010 pharmacovigilance legislation.

Article 57(2), second subparagraph, point c of Regulation (EC) 726/2004 requires marketing-authorisation holders to inform the Agency of any new or varied marketing authorisations granted in the European Union as of 2 July 2012 using the updated electronic format provided by the Agency on 5 March 2012.

On 28 June 2012, the Agency hosted a third workshop with European pharmaceutical industry associations on the implementation of this Article, focusing on a proposal for maintenance of information on human medicines. During the workshop, attendees were supportive of the Agency’s proposals, as follows:

  • Marketing-authorisation holders should submit information on new marketing authorisations granted after 2 July 2012 using the electronic format published by the Agency. The information should be supplied within 15 calendar days from the date of the notification of the granting of the marketing authorisation by the competent authority, including the availability of the approved summary of product characteristics;
  • Marketing-authorisation holders should inform the Agency about changes to marketing authorisations using a two-speed system based on expedited and routine notifications. This system will be applied following agreement on the process, which will take place at a follow-up workshop with European pharmaceutical industry associations at the Agency in September 2012.

The Agency will be providing further guidance on both of these issues in the near future.

At the September workshop, further discussion will take place on the following topics:

  • The scope and the process of the post-authorisation maintenance activities relating to variations, extensions of marketing authorisations and transfers of marketing authorisations. This is with a view to develop a common, harmonised approach for all medicines, independently of the authorisation and variation procedure;
  • The maintenance of the name and contact details of the qualified person responsible for pharmacovigilance, the pharmacovigilance enquiry details and the location of the pharmacovigilance system master file, as well as the handling of suspensions, revocations and withdrawals.

The Agency is supporting marketing-authorisation holders with data submission through the provision of a data entry tool called EVWEB, online and face-to-face training, and a dedicated helpdesk.

In addition, the Agency is setting up a joint implementation group with representatives from the pharmaceutical industry and the Agency. This group will address technical and operational implementation questions and facilitate the drafting of a roadmap towards the implementation of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards, taking international harmonisation work into account.

How useful is this page?

Average rating:

 Based on 26 ratings

Add your rating:

See all ratings
6 ratings
6 ratings
6 ratings
4 ratings
4 ratings

Related information

Contact point:

E-mail: art57@ema.europa.eu
Tel.: +44 (0)20 7523 7010