The European Medicines Agency (EMA) provides guidance and templates to provide marketing authorisation applicants with practical advice on how to draw up the product information for human medicines, which includes the summary of product characteristics, labelling and package leaflet.
EMA's guidance explains the content that should be included in these documents, as well as standard headings and the most commonly used standard statements and terms in all official European Union (EU) languages plus Icelandic and Norwegian, and defines the format and layout for the product information.
EMA's guidance is without prejudice to:
- any final positions from the Agency, the Committee for Medicinal Products for Human Use (CHMP) or European institutions relating to the contents of the documents;
- the binding nature of the relevant legislation;
- any legal interpretations given by the European Commission or the Court of Justice of the European Union.
Guidance is available on flexibilities to help developers of COVID-19 vaccines prepare and roll out packaging and labelling for their vaccines quickly. It includes practical advice on exemptions to some requirements that are possible, while keeping in line with regulatory requirements:
The guidance aims to facilitate the large-scale and rapid deployment of COVID-19 vaccines within the EU.
It provides details further to the European Commission's memorandum of Understanding (MoU) with Member States on regulatory flexibility for COVID-19 vaccines.
Guidance is available on flexibilities to help developers of COVID-19 treatments prepare and roll out packaging and labelling for their treatments quickly:
Electronic product information (ePI) refers to the authorised, statutory product information for medicines (including the summary of product characteristics, package leaflet and labelling) adapted for handling in electronic format and dissemination via the web, e-platforms and in print.
ePI uses a semi-structured format, based on a common electronic standard for product information.
The EU ePI Common Standard is available, based on Fast Healthcare Interoperability Resources (FHIR), a technical standard describing data formats and elements and an application programming interface for exchanging electronic health records:
The EU ePI Common Standard is a key deliverable of the ePI project run by EMA, national competent authorities and the European Commission in 2021.
A 2022-2023 pilot project is currently developing tools and guidance to test the use of ePI prior to its roll out.
This pilot is supported by the EU funding programme EU4Health.
Updated information on its progress is made available at quarterly public system 'demo' events:
- Quarterly system demo - Q4 2022 (21/12/2022)
- Quarterly system demo - Q3 2022 (28/09/2022)
EMA, the Heads of Medicines Agencies (HMA) and European Commission published key principles to guide the development and use of ePI for human medicines in the EU in 2020.
For more information:
Report on public consultation on EU Common Standard for electronic product information (ePI) - Summary of comments received and next steps (PDF/753.47 KB)
First published: 22/02/2022
EU Common Standard for electronic product information (ePI) - categorised comments received following public consultation (XLSX/186.42 KB)
First published: 22/02/2022
Applicants and marketing authorisation holders can request the inclusion of mobile scanning and other technologies (including quick response (QR) codes) in the context of an evaluation procedure, including:
- as part of the initial marketing-authorisation application;
- after the medicine is authorised via Article 61(3) with the rapporteur's involvement;
- as part of other procedures affecting annexes.
They should request inclusion of these technologies by submitting the following form, along with all relevant information within module 1.3.1 of the dossier:
For guidance on submission requirements, general principles of acceptability and assessment of mobile scanning and other technology requests, see:
This guidance replaces EMA's guidance document on ‘Quick Response (QR) codes in the labelling and package leaflet of centrally authorised medicinal products.’
A list of national contact points has been set up for the review of national versions of mobile scanning and other technologies approved through the centralised procedure.
There is no direct legal requirement to include information on doping in sport in the product information of centrally authorised medicines. The Agency advises applicants not to include statements on doping.
However, the Agency acknowledges the public-health interest in accessing up-to-date information on substances that can be used in doping. This information is available on the website of the World Anti-Doping Agency (WADA), an independent international organisation created to promote, coordinate and monitor the fight against doping in sport in all its forms:
From January 2022, a derogation expires concerning the status of Irish as a working language of the EU Institutions.
This means that decisions of the European Commission addressed to EU Member States, including the product information they contain, will be translated into Irish together with the other official EU languages, for the following procedures:
Irish will also be the authentic language of Commission decisions addressed to any marketing authorisation holder established in Ireland, unless they request a language waiver using the template below.
Marketing authorisation holders established in Ireland should request a language waiver if they want English to be the authentic language of their product information and of decisions addressed to them by the European Commission.
A language waiver will apply to all marketing authorisations held by the recipient. Further guidance and background information is available below.