Electronic Product Information: A New Wave in EU Regulations
Author: Genpro Medical Writing Team.
The product information (PI) of a medicine is the cardinal source of regulated information for any product that is authorised for use in humans in European region. It includes the outer and inner label, summary of product characteristics, and package leaflet (PL); the latter two were being produced in paper print till recent past. A collaboration between European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and the European Commission (EC) addressed shortcomings of the paper-based PI. Thus, an electronic product information (ePI) was developed- to ensure access to new information and ease coordination between multiple European Union (EU) initiatives. A set of ‘key principles’ were drafted, considering the needs and concerns of all the stakeholders, as well as public consultation.
Published on 29th Jan 2020, the key principles for ePI will also guide future development on the same. The highlights are as follows:
The ePI is defined as “authorised and statutory” with a “semi-structured” format forged using a “common EU electronic standard”. While formats like PDF, Word, and free texts are not accepted; the common electronic standard defines the technical features like mark-up language, controlled vocabularies, and interoperability specifications of ePI.
2. Benefits to Public Health: The ePI is immensely important for public health as it-
- Provides up to date information on a medicine’s safety, benefits, and conditions for use
- Bridges appropriate information with the need of the patient/consumer/healthcare professional (HCP)
- Thus, it leads to informed decisions made by patients/consumers/ HCPs
Additionally, ePI will be accessible across people with varied abilities. For example, formats for the physically impaired or those with learning challenges; large fonts for the partially sighted; and audio formats for blind and illiterate users. The ePI ensures wide availability of authorised information via searches on web interfaces and on mobile applications.
3. Efficiency Gain for Regulatory Systems:
The ePI enables automated and simultaneous update of information across annexes and products. This eliminates manual efforts and resulting redundancies, thus making regulatory procedures efficient. Openly accessible information helps regulators and researchers analyse the evolution of medicines and forecast trends.
4. Existing Legislative Framework:
The ePI will complement the paper PI (legally required as per pharmaceutical legislative Articles 58, 59, and 62 of Directive 2001/83/EC). Thus, the ePI acts as an expansion of the paper PI but is not a legal requirement, at least for now. The ePI provides complete regulator-approved PI without any promotional information, amendment, or additional data. It will be freely available and open to public access. If access to ePI (in case of mobile applications) deals with processing personal data, it should be in accordance with the Regulation (EU) 2016/679 (GDPR)2 and Regulation (EU) 2018/17253 as applicable to EU institutions.
The forecast for the ePI is to be introduced at submission and used through evaluation. However, at regulatory authorities’ discretion, it can continue to be done as currently and be created at the end of regulatory procedures. A future roadmap describes: a feasibility analysis for implementation, access to the ePI through EMA and Member state websites, and reproduction by third parties for greater reach. Considering national priorities and resource availability, the timelines for implementation would be kept flexible and driven by a detailed roadmap by HMA and EMA.
6. EU Context:
The ePI should be available in all official EU languages plus Icelandic and Norwegian; no extra translations are required apart from those done for PI. The ePI should be designed with a global perspective of digital healthcare. It should interoperate with other EU digital health systems like cross-border prescription, electronic health records, pharmacovigilance systems, and other current and future systems.
- Harmonized understanding of the ePI creation and accessibility across EU. Based on a common standard of requirements stated in key principles
- Heightened protection of public health by expanded access to up-to-date information including users with diverse abilities
- Efficient regulatory process for updated and accurate information on medicines and a rich knowledge base about evolution trends in medicines for researchers
- Complements the paper PI: paper PL to include a link to the ePI (as the most up-to-date version of PL); thus, publishing non-promotional, original PI content upholding patients’ right to protected and open access to regulated information
- The future of ePI is usage from submission through all evaluation process and available on EMA and NCA websites with flexible timelines for implementation
- ePI designed for usage in all official EU languages (including Icelandic and Norwegian) and interoperability across platforms
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- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ELI: http://data.europa.eu/eli/dir/2001/83/2012-11-16
- Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance) ELI: http://data.europa.eu/eli/reg/2016/679/2016-05-04
- Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (Text with EEA relevance.) PE/31/2018/REV/1 OJ L 295, 21.11.2018, p. 39–98 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV) ELI: http://data.europa.eu/eli/reg/2018/1725/oj
- Electronic product information for human medicines in the EU: key principles A joint EMA–HMA–EC collaboration. Accessed online at https://www.ema.europa.eu/en/electronic-product-information-human-medicines-european-union-key-principles on 07 Feb 2020.