# ELECTRONIC PATIENT INFORMATION LEAFLET (ePIL) - PREREQUISITES ## Assessment of prerequisites *Prerequisites represent the broader context or resources necessary for the successful implementation and operation of the ePIL tool. Although not specific to the tool itself, these prerequisites are essential for ensuring its proper functioning once deployed.* ### Operational For the ePIL platform to be effective, it must be hosted by a trusted authority that ensures the reliability and credibility of the information provided. The EMA, which hosts its [database for centrally approved medicinal products](https://www.ema.europa.eu/en/medicines) and the [PLM Portal](https://plm-portal.ema.europa.eu/), plays a crucial role in this regard. Trust in the EMA by both healthcare professionals and citizens/patients is essential for the successful adoption and utilisation of ePILs. This trust is built through transparent operations, regular updates based on the latest scientific evidence and clear communication regarding the safety and efficacy of medicinal products. Additionally, the EMA's established relationships with National Competent Authorities (NCAs) and other stakeholders reinforce its authority and credibility. It is important to note that the EMA’s PLM Portal is currently a pilot project and does not yet provide electronic product information for all authorised medicinal products in the EU, but only a selection. While we would ideally rely on the PLM Portal, it is not yet complete. Therefore, in the interim, the EMA’s database for centrally approved medicinal products could be utilised, as it provides product information, including the patient information leaflet, in all EU languages for centrally approved medicinal products. For medicinal products that were not centrally, but nationally approved, national registers will need to be accessed. A list of the national registers, which host the patient information leaflets in national languages, can be found on the EMA’s website [here](https://www.ema.europa.eu/en/medicines/national-registers-authorised-medicines). ### Legal and ethical Currently, EU legislation mandates that patient information leaflets must be provided in paper form. To implement ePILs exclusively, exemptions will be required. Depending on the marketing authorisation of the medicinal product, these exemptions need to be obtained from the EMA (in consultation with the NCAs) for centrally authorised products or from NCAs for products authorised through decentralised or mutual recognition procedures. Navigating these regulatory requirements adds complexity to the implementation process. Countries implementing ePILs need clear guidance on how to contact the appropriate NCA to seek authorisation for exemptions. This includes obtaining contact details and procedural information to streamline the approval process. Proposed revisions to the General Pharmaceutical Legislation suggest that, starting possibly from 2028, Member States may be allowed to provide package leaflets electronically only, with the stipulation that patients can request a printed copy free of charge. This legislative change could potentially eliminate the need for current exemptions by allowing for fully digital medicinal product information, as already demonstrated during emergencies like the COVID-19 pandemic. ### Policy Stakeholder Engagement: Engage with policy stakeholders to build support for the ePIL, emphasising the benefits of improved patient information and environmental impacts. ### Technical The successful deployment of ePILs requires robust technological infrastructure. This includes the development and maintenance of secure digital platforms where ePILs can be accessed, ensuring these platforms are user-friendly and accessible to individuals with varying levels of digital literacy. The platform to host the ePILs has already been established by the EMA and a group of NCAs as part of their one-year pilot to test the use of electronic product information. The pilot project started in July 2023 and the platform with the ePI authoring tool can be accessed on the EMA’s [Product Lifecycle Management Portal](https://plm-portal.ema.europa.eu/). ## Filling the gaps *Meeting the prerequisites is often a long-term endeavour that goes far beyond the scope of the implementation plans. This section suggests potential workarounds for launching the ePIL project even when some prerequisites are not fully met. Although these measures may not deliver the full benefits immediately, they can create the visibility and momentum needed to justify further efforts to meet the prerequisites.* ### Operational As the PLM Portal is not complete yet and currently only provides a small amount of ePILs, the EMA’s [database for centrally approved medicinal products](https://www.ema.europa.eu/en/medicines) will be utilised in the interim. This database provides product information, including the patient information leaflet, in all EU languages for centrally approved medicinal products. The Summary of Product Characteristics, Labels and Patient Information Leaflet are aggregated into a single large document. This implies that this workaround can be used only to deploy the technical mechanisms to access the ePIL. However, the presented documents for centrally approved products will not be appropriate for patient information. For medicinal products that were not centrally, but nationally approved, national registers will need to be accessed. A list of the national registers, which host the patient information leaflets in national languages, can be found on the EMA’s website. An example for an existing platform on national level that hosts ePILs is [Infomed](https://extranet.infarmed.pt/INFOMED-fo/index.xhtml), Portugal’s national database for medicinal products for human use. In Belgium, the [Federal Agency for Medicines and Health Products Database](https://medicinesdatabase.be/human-use) provides ePILs in French, Dutch and English. ### Legal and ethical In cases where full authorisation is not immediately achievable, ePILs can be introduced as an additional resource alongside traditional paper leaflets. This dual approach allows stakeholders to gradually adapt to digital formats while maintaining compliance with existing regulations. In case of this “Plan B”, real world evidence could be collected to support the removal of the paper leaflet in the future. ### Policy Proposed revisions to the General Pharmaceutical Legislation suggest that, starting possibly from 2028, Member States may be allowed to provide package leaflets electronically only. This shift would eliminate the need for exemptions currently required to use ePILs instead of paper leaflets.