Details

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

TheFind feeout formore theabout PIM designation is £3,986.

The fee for assessment of the scientificfees opinionwe forcharge new chemical or biological medicinal products is £25,643 and the renewal fee (if applicable) is £12,821.at MHRA fees.

The fee for the assessment of the scientific opinion for new indications is £8,309 and the renewal fee (if applicable) is £4,154.

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
12-Aug-24	19-Aug-24	02-Oct-24
09-Sep-24	16-Sep-24	30-Oct-24
07-Oct-24	14-Oct-24	27-Nov-24
04-Nov-24	11-Nov-24	25-Dec-24
02-Dec-24	09-Dec-24	22-Jan-25
06-Jan-25	13-Jan-25	26-Feb-25
03-Feb-25	10-Feb-25	26-Mar-25
03-Mar-25	10-Mar-25	23-Apr-25
31-Mar-25	07-Apr-25	21-May-25

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