Reporting requirements for marketing-authorisation holders

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Marketing-authorisation holders (MAHs) of medicines authorised in the European Union (EU) and European Economic Area (EEA) must submit information on these medicines to the European Medicines Agency (EMA) and must keep this information up-to-date.

This is a legally binding requirement from the EU pharmaceutical legislation (Article 57(2) of Regulation 726/2004).

Marketing-authorisation holders are required to submit information on new marketing authorisations within 15 calendar days from the date of notification of the granting of the marketing authorisation by the national competent authority. This obligation applies to:

  • nationally authorised medicinal products;
  • centrally authorised medicinal products;
  • medicinal products authorised through the mutual recognition procedure;
  • medicinal products authorised through the decentralised procedure.

Marketing-authorisation holders are also required to submit information concerning all medicinal products for which they hold a marketing authorisation in EEA countries outside the EU (i.e. Iceland, Liechtenstein and Norway), as the pharmacovigilance legislation is part of the EEA Agreement.

Information on any amendments to the terms of marketing authorisations following variation, transfer, renewal, suspension, revocation or withdrawal must be notified to the EMA no later than 30 calendar days from the date on which the amendments have been authorised.

Updated: On 19 October 2015 the Agency launched a new service to national competent authorities, providing them with continuous access to key Article 57 data. National competent authorities can access product details based on the latest version of information submitted for medicinal products with a valid marketing authorisation in the European Economic Area, by creating a new report in the EudraVigilance Data Analysis System (EVDAS).

The service supports an administrative simplification in line with the European Commission’s variations guideline. Once the Article 57 database is considered functional, marketing-authorisation holders may notify EMA of administrative changes concerning the qualified person for pharmacovigilance (QPPV) and location of the pharmacovigilance system master file (PSMF) through the Article 57 database only, without the need to submit a type IAIN variation to vary the marketing authorisation.

The EMA Management Board considered the Article 57 database functionality for notifying changes to the QPPV and PSMF at its December 2015 Management Board meeting. The Board agreed that the database is functional for the purpose of notifications of changes to QPPV and PSMF information and that this takes effect from 1 February 2016. From that date companies no longer need to notify EMA (for centrally authorised products) or national competent authorities (for nationally authorised products) of changes to the QPPV or PSMF data by submitting a type IAIN variation. No final variation is required to notify an explicit cross reference to Article 57 as the source of QPPV and PSMF information.

In line with their legal obligations, companies should continue to ensure their entries in the Article 57 database for medicinal products for human use are up-to-date, including the QPPV and PSMF information.

For more information, see the European Commission's press release published on 22 January 2016.

For full details on the reporting requirements, see the legal notice and detailed guidance on our dedicated Guidance documents webpage.

Implementation of Article 57(2) 

The implementation of Article 57(2) requirements is a core project within the Agency’s Pharmacovigilance Programme.

The programme is aimed at providing robust, high quality and sustainable systems and services to gather and analyse data and information for pharmacovigilance. The Article 57 project deliverables have been achieved in different phases over the past four years and the ongoing collaboration of MAHs will be vital to maximise the utility of this information for pharmacovigilance.

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The Agency is currently in a transition phase, during which the focus is on the maintenance of data submitted on authorised medicines. The data-submission system now only accepts submissions that are in line with the updated reporting requirements, as stated in the legal notice and detailed guidance documents on the Guidance documents page.

This transition maintenance phase will continue until the phased implementation of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards, expected to commence in 2016.

Support to industry

The Agency is supporting industry in the implementation of the transition maintenance phase by providing the required technical support with teleconferences and Joint Implementation Working Group (IWG) meetings to address any questions regarding implementation. The approach for the transition maintenance phase has been endorsed by representatives of pharmaceutical-industry associations at IWG meetings.

The Agency aids industry in the data submission process in the following ways:

  • To help industry improve the quality of the data submitted, the Agency has provided guidance on the quality-control methodology, which outlines the intended scope of each of the data elements and the criteria to ensure that the data is of adequate and expected quality. The Agency developed this guidance in liaison with the Joint IWG.
  • A data-export functionality is available in EVWEB (the Agency’s dedicated EudraVigilance web interface) to enable marketing-authorisation holders to export their own data during the transition maintenance phase. For more information, see the the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) product export tool user manual.
  • A bulk update manager tool was also released to enable marketing-authorisation holders submitting information using EVWEB to perform bulk data operations on their products in the XEVMPD. The tool facilitates editing key data fields and supports the re-submission of this data to the XEVMPD repository. For full details, see the XEVMPD bulk update manager user guide.
  • The Agency carried out a quality control and review of the data received by industry and the applicable XEVMPD controlled vocabulary lists are available under the Controlled vocabularies: quality control section on the Guidance documents page.

The Agency has begun a systematic review of the quality and integrity of the information submitted from July 2014 to ensure that the information submitted is accurate and up-to-date. Full details of the review are available in Quality control of medicinal-product data submitted as per the legal requirement introduced by Article 57(2) of Regulation (EC) No 726/2004.

Update of the format in compliance with ISO IDMP standards

The transition maintenance submission processes will continue until the implementation of the ISO IDMP standards. At this stage, the Agency will update the data-submission format in line with these standards, including information on pack sizes. This is expected to take place in 2016.

Transition to ISO IDMP implementation is required by Article 25 and 26 of Commission Implementing Regulation (EU) No 520/2012.

The ISO IDMP standards were finalised in 2012. Implementation guides for these standards are currently under development at international level. 

The Agency is working on a roadmap towards the implementation of the ISO IDMP standards, in consultation with the EU regulatory network and European pharmaceutical-industry associations. The roadmap will cover:

  • a gap analysis comparing XEVMPD and ISO IDMP;
  • a migration plan for XEVMPD to ISO IDMP;
  • an implementation plan. 

The Agency and the EU Regulatory Network are pursuing an open dialogue with industry to discuss aspects of implementing the ISO IDMP standards in Europe, by establishing an ISO IDMP Task Force, with the participation of terminology organisations, software vendors and developers of medicinal product dictionaries or databases.

The Task Force will be responsible for advising on planning, development, implementation and maintenance of the ISO IDMP Standards in the EU, in line with requirements defined at international level and based on agreed EU implementation principles. Further information is available under Implementation of International Organization for Standardization (ISO) identification of medicinal products (IDMP) standards.

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