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About Article 57

What is Article 57?

Article 57 of Regulation (EC) No. 726/2004 determines the new requirements how marketing authorisation holders should submit data electronically to the European Medicines Agency. Article 57 includes a series of requirements regarding the format for the electronic submission of information on medicinal products for human use.

Which format for electronic submissions is required by Article 57?

According to Article 57 marketing authorisation holders must use the EudraVigilance Medicinal Product Report Message (EVPRM) published on 1 July 2011 as the format to electronically submit to the Agency information on all medicinal products for human use authorised or registered in the European Union.

How can you electronically submit medicinal product information?

The electronic submission of medicinal product information can be accomplished in two ways:

• Pharmaceutical companies can develop tools to initiate the electronic submissions of information on medicinal products in full compliance with the data elements and the XSD schema via the EudraVigilance Gateway to the Agency.
• Pharmaceutical companies can use the data entry and submission tools provided by the Agency; the latter are specifically developed for Small and Medium-Sized Enterprises (SMEs), but are made available to any pharmaceutical company for the purpose of electronic submission of information on medicinal products to the Agency.

A specific training programme for pharmaceutical companies is currently being developed by the Agency. Dates and the location for the training will be announced on the EMA and EudraVigilance website.

Which timelines are important to know?

By 2 July 2012 at the latest, marketing authorisation holders must electronically submit to the Agency information on all medicinal products for human use authorised or registered in the European Union using the required format. This is independent of the authorisation procedure of the medicinal product. It is also important to know that medicinal product information for new, varied, suspended, or revoked marketing authorisations in the European Union after 2 July 2012 must be submitted by marketing authorisation holders electronically to the Agency immediately, and no later than 15 calendar days from the date of authorisation, variation, suspension, or revocation. This must also include information where the medicinal product has been withdrawn.

What is the implication of Article 57?

According to Article 57 you will need to:

• Collect information (medicinal products for human use) by July 2012: Collect very detailed information for a long list of mandatory fields; fill out a special section about active substances and excipients that is independent of the authorisation procedure (cp, mrp/dcp, national); give information for all products registered/authorised in the EU, including those not marketed (this is the responsibility of marketing authorisation holder).
• Submit this data by July 2012 using the new electronic format: xEVPRM = extended "EudraVigilance Product Report Message"; This electronic format is similar to the existing format but has additional data elements including special sections, including PPI – Printed Product Information; and more.
• Submit relevant changes within 15 calendar days (after July 2012): You must submit any variation; new marketing authorisation; suspension; revocation/withdrawal – including information about Product Information in national languages.

How will Article 57 affect the industry?

Article 57 will have a huge impact on the industry because you will have to undertake three projects at the same time: 1. Collection and an initial check of your data about your products; 2. Electronic submissions by marketing authorisation holders; 3. Submission of changes after July 2nd 2012. Successful completion of each project requires many time-consuming tasks. The size of the task ahead for many marketing authorisation holders will be significant, and will require the definition of a detailed plan and its rapid implementation if the deadline of July 2012 is to be met, and thereby maintaining compliance with the pharmacovigilance legislation.

Where can I get detailed guidance for implementation of requirements according to Article 57?

For more detailed information go to:
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/07/WC500108213.pdf

What is the aim of Article 57?

The European Medicines Agency (EMA) is implementing the electronic submission of information on medicines in the context of the new pharmacovigilance legislation. As required by this legislation, the Agency published the format for the electronic submission of information on medicinal products for human use on 1 July 2011. Article 57 shows the type of information that companies will need to submit to the Agency by the legal deadline of 2 July 2012. This information will help the Agency to: create a list of all medicines authorised and registered in the EU, including medicines authorised centrally via the Agency and medicines authorised by regulatory authorities in EU Member States; identify medicines accurately, especially medicines included in reports of suspected adverse reactions; and co-ordinate the regulation and safety-monitoring of medicines across the EU.