Medicines Healthcare Products Regulatory Agency
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
The fee for the PIM designation is 3,986.
The fee for assessment of the scientific opinion for new chemical or biological medicinal products is 25,643 and the renewal fee (if applicable) is 12,821.
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
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)
*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: