# Early Access to Medicines Scheme: Overview Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/fd6a6133-49fc-406d-8f63-ec6b06d9d43b Type: Guidance Published: September 9, 2024 Updated: March 2, 2026 > The UK Medicines and Healthcare products Regulatory Agency (MHRA) provides this guidance for the Early Access to Medicines Scheme (EAMS), a voluntary program designed to give patients with life-threatening or debilitating conditions access to innovative treatments before they receive formal marketing authorization. The regulatory framework is governed by Regulation 167C(1) of The Human Medicines Regulations 2012 and the 2022 Amendments. To participate, pharmaceutical companies must undergo a two-step evaluation: securing a Promising Innovative Medicine (PIM) designation and obtaining a Scientific Opinion. This opinion, which assesses the benefit-risk balance, is valid for one year and supports prescribing by healthcare professionals. While this document is general guidance and does not detail specific company violations or individual inspection dates, it mandates that all applying companies adhere to a strict submission calendar, with cycles scheduled through 2028. Required actions for applicants include paying non-refundable fees and providing comprehensive data to justify medical necessity. The MHRA emphasizes that this scheme does not replace standard licensing but offers a pathway for addressing unmet medical needs through established treatment protocols and public assessment reports. --- ## Content Overview The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need (new medicines and new uses [indications] for established medicines). Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) will issue a scientific opinion on the benefit/risk balance of the medicine, based on the data available when the EAMS submission was made. Patient access is provided after a 2-step evaluation process: *the Promising Innovative Medicine (PIM) designation *the Early Access to Medicines Scheme Scientific Opinion The scientific opinion supports prescribing of the EAMS medicine by the Healthcare Professional; in turn, the EAMS medicine is made available by the EAMS Scientific Opinion holder (usually a pharmaceutical company). The scientific opinion lasts up to a year and can be renewed. The scheme is voluntary and the scientific opinion from the MHRA does not replace the normal licensing procedures for medicines. Comprehensive information for applications is published in our guidance Early Access to Medicines Scheme - Information for Applicants . Fees Find out more about the fees we charge at MHRA fees . The fee is not refundable if your application is not successful. Dates for submission, Day 1 and Day 45 You need to make your EAMS scientific opinion submission by one of the dates below: Submission Date Day 1 Day 45 13-Jan-26 20-Jan-26 06-Mar-26 10-Feb-26 17-Feb-26 03-Apr-26 10-Mar-26 17-Mar-26 01-May-26 07-Apr-26 14-Apr-26 29-May-26 12-May-26 19-May-26 03-Jul-26 16-Jun-26 23-Jun-26 07-Aug-26 14-Jul-26 21-Jul-26 04-Sep-26 11-Aug-26 18-Aug-26 02-Oct-26 15-Sep-26 22-Sep-26 06-Nov-26 13-Oct-26 20-Oct-26 04-Dec-26 03-Nov-26 10-Nov-26 25-Dec-26 08-Dec-26 15-Dec-26 29-Jan-27 05-Jan-27 12-Jan-27 26-Feb-27 02-Feb-27 09-Feb-27 26-Mar-27 09-Mar-27 16-Mar-27 30-Apr-27 06-Apr-27 13-Apr-27 28-May-27 04-May-27 11-May-27 25-Jun-27 08-Jun-27 15-Jun-27 30-Jul-27 06-Jul-27 13-Jul-27 27-Aug-27 03-Aug-27 10-Aug-27 24-Sep-27 07-Sep-27 14-Sep-27 29-Oct-27 05-Oct-27 12-Oct-27 26-Nov-27 02-Nov-27 09-Nov-27 24-Dec-27 14-Dec-27 21-Dec-27 04-Feb-28 11-Jan-28 18-Jan-28 03-Mar-28 15-Feb-28 22-Feb-28 07-Apr-28 14-Mar-28 21-Mar-28 05-May-28 11-Apr-28 18-Apr-28 02-Jun-28 16-May-28 23-May-28 07-Jul-28 13-Jun-28 20-Jun-28 04-Aug-28 11-Jul-28 18-Jul-28 01-Sep-28 15-Aug-28 22-Aug-28 06-Oct-28 12-Sep-28 19-Sep-28 03-Nov-28 10-Oct-28 17-Oct-28 01-Dec-28 07-Nov-28 14-Nov-28 29-Dec-28 EAMS applications: pending, refused, granted View the number of EAMS applications pending, refused and granted . View current scientific opinions , including public assessment reports and EAMS treatment protocols. View expired scientific opinions . EAMS task group and principles guidance A government - industry stakeholder task group has produced additional EAMS guidance, including UK wide core principles Definitions: *The Early Access to Medicines Scheme means the scheme of that name established and operated under regulation 167C(1) of The Human Medicines Regulations (2012) The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (legislation.gov.uk) *EAMS medicinal product means a medicinal product that has been included in the Early Access to Medicines Scheme by means of the licensing authority issuing an EAMS scientific opinion *EAMS Scientific Opinion holder means the holder of an EAMS scientific opinion, and accordingly, is the person who places on the market the product to which the opinion relates Contact: please contact our EAMS coordinator for help and queries: EAMS@mhra.gov.uk ## Attachments - [Early Access to Medicines Scheme - Overview](/government/publications/early-access-to-medicines-scheme-overview/early-access-to-medicines-scheme-overview)