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.
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.
It aims at developing a common?electronic standard?for ePI, carrying out a proof-of-concept exercise for implementing the standard and creating a roadmap for implementation across the EU.
EMA?will publish?progress updates and details of stakeholder consultations with patients, healthcare professionals, academia?and pharmaceutical industry.
In January 2020, EMA, the Heads of Medicines Agencies (HMA) and the European Commission published key principles to guide the development and use of ePI?for human medicines in the EU:
The development of electronic tools to improve access of patients and healthcare professionals to information on medicines?is one of the key recommendations?in a 2017 report from the European Commission and?EMA's?subsequent action plan to improve the product information for EU medicines:
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:
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: