The EMA has established procedures for publishing information following the refusal of a new marketing authorisation application or an application to vary an existing authorisation, and following the withdrawal of an application by the applicant.

Negative opinions and withdrawn applications information under the 'Authorisation details' tab). Other content available only as a web page (e.g.Tabulated overview of procedural steps taken before and after authorisation.The other elements of the EPAR are published in English only: Package leaflet and summary of product characteristics.Some components of the EPAR are always published in all official EU languages: Summaries of opinion can be found under Pending EC decisions (human) and Pending EC decision (veterinary).

Pending the European Commission decision, the EMA publishes a ' summary of opinion' immediately after the scientific opinion is adopted. In addition, whenever the product information is updated, the medicine's EPAR is updated accordingly to reflect the latest version.įor a new marketing authorisation or a major change to the authorisation terms, this process takes around two months following the adoption of an EMA scientific opinion, so there is a delay between adoption of opinion and publication or updating of the EPAR. The EPAR for each medicine is published or updated after the European Commission has issued a decision regarding the application.

Reflection paper on European public assessment report summary for the public.

The detailed format and content of the public-friendly overview have been adapted and enhanced over time, but the main principles are set out in a reflection paper: Public assessment report for the initial authorisation public assessment report(s) for any variation concerning major changes to the marketing authorisation orphan maintenance assessment report or withdrawal assessment report (as of 17 January 2018) tabulated overview of procedural steps taken before and after authorisation. Package leaflet and summary of product characteristics labelling list of all authorised presentations pharmacotherapeutic group therapeutic indications. Key details about the product and the marketing authorisation holder. Public-friendly overview in question-and-answer format. The below table provides an overview: Section If the original terms and conditions of a marketing authorisation are varied, the EPAR is updated to reflect such changes with an appropriate level of detail.ĮPARs are displayed on the EMA website using four different sections containing different components of the EPAR.

Information handled during the scientific assessment which is considered confidential is removed before an EPAR is published.ĮPARs are updated periodically to reflect the latest regulatory information on medicines. EPARs are displayed on the EMA website and the individual components can be viewed online, downloaded and/or printed out. Content and formatĪn EPAR is not a single document but an information resource containing several components, including a core set of regulatory documents. The EPAR content and structure have therefore evolved over time and may be further developed in future.Īn important role of the EPAR is to reflect the scientific conclusions of the relevant EMA committee at the end of the assessment process, providing the grounds for the committee opinion on whether or not to approve an application.Īll EPARs are published on the EMA website and can be viewed under human medicines and veterinary medicines. The EPAR is referred to in Article 13(3) of Regulation (EC) No 726/2004, which requires EMA to publish a public assessment report for each centrally authorised medicine together with a public-friendly overview.ĮMA has developed the EPAR concept over time to ensure that it delivers a usable, transparent and appropriately detailed body of information. This follows an assessment by EMA of an application submitted by a pharmaceutical company in the framework of the Central authorisation of medicines.Īn EPAR provides public information on a medicine, including how it was assessed by EMA. Overall conceptĪ European public assessment report (EPAR) is published for every human or veterinary medicine application that has been granted or refused a marketing authorisation. The main vehicle for this information is known as a European public assessment report. The European Medicines Agency (EMA) publishes detailed information on the medicines assessed by the Committee for Medicinal Products for Human Use ( CHMP) and Committee for Medicinal Products for Veterinary Use ( CVMP).

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