Product-information requirements
HumanProduct information
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.
Also on this topic
- Product-information templates - Human
- How to prepare and review a summary of product characteristics
- Exemptions to labelling and package-leaflet obligations
- Linguistic review - Human
- Mock-ups and specimens
- Product information: Reference documents and guidelines
- Excipients labelling
- Electronic product information (ePI)
Guidance for developers of COVID-19 vaccines
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 for developers of COVID-19 treatments
Guidance is available on flexibilities to help developers of COVID-19 treatments prepare and roll out packaging and labelling for their treatments quickly:
Mobile scanning and other technologies
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 Member states contact points for review of national versions of the content of mobile scanning and other technologies has been set up for the review of national versions of mobile scanning and other technologies approved through the centralised procedure.
Information on doping
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:
Irish language
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 alanguage 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.