Guidance

Apply for the early access to medicines scheme (EAMS)

Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.

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.

Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) will give a scientific opinion on the benefit/risk balance of the medicine, based on the data available when the EAMS submission was made.

The opinion lasts for a year and can be renewed.

The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines.

The scientific opinion will be provided after a 2-step evaluation process:

  1. the promising innovative medicine (PIM) designation
  2. the early access to medicines scientific opinion

See the number of applications made to the early access to medicines scheme for the promising innovative medicine (PIM) designation and the scientific opinion for more information.

Promising innovative medicine (PIM) designation

The PIM designation will give an indication that a product may be eligible for the EAMS based on early clinical data. The PIM designation will be issued after an MHRA scientific meeting and could be given several years before the product is licensed.

To apply for a PIM designation submit the PIM application form (MS Word Document, 354KB) and send it to eams@mhra.gov.uk.

See guidance on applying for a PIM designation (PDF, 187KB, 3 pages) .

Scientific opinion

The scientific opinion describes the risks and benefits of the medicine based on data gathered from the patients who will benefit from the medicine. The opinion supports the prescriber and patient to make a decision on whether to use the medicine before its licence is approved.

View guidance on applying for a scientific opinion (PDF, 178KB, 6 pages) , including the pre-submission meeting.

Pre-submission meeting

If you want to apply for an EAMS scientific opinion from MHRA you must have a PIM designation. You should also attend a pre-submission meeting with MHRA to:

  • ensure that your product is suitable for an EAMS scientific opinion application
  • discuss the format of the data you need to submit to support the opinion

To apply for a pre-submission meeting fill out the pre-submission meeting request form (MS Word Document, 322KB) and send it to eams@mhra.gov.uk.

Apply for a scientific opinion

To apply for a scientific opinion you should include the following documents, which are part of the EAMS dossier:

  • a completed scientific opinion application form (MS Word Document, 494KB)

  • a covering letter including the proposed submission slot and EAMS number
  • summary of the pharmacovigilance system master file (PSMF)
  • a risk management plan (RMP) using the RMP template (MS Word Document, 375KB)

Send your completed submission to eams@mhra.gov.uk.

EAMS public assessment report (PAR)

Following a positive EAMS scientific opinion, MHRA will publish a public assessment report (PAR) and the EAMS treatment protocol on GOV.UK. The PAR will include:

  • how the product is used and how it works
  • summary of the key clinical studies
  • the risks and benefits of the product
  • the reason for the positive EAMS scientific opinion
  • any uncertainties
  • information about ongoing clinical studies
  • measures in place to monitor and manage risk

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
4 June 2018 11 June 2018 25 July 2018
30 July 2018 6 August 2018 19 September 2018
27 August 2018 3 September 2018 17 October 2018
24 September 2018 1 October 2018 14 November 2018
22 October 2018 29 October 2018 12 December 2018
10 December 2018 17 December 2018 30 January 2019
7 January 2019 14 January 2019 27 February 2019
4 February 2019 11 February 2019 27 March 2019
4 March 2019 11 March 2019 24 April 2019
8 April 2019 15 April 2019 29 May 2019
6 May 2019 13 May 2019 26 June 2019
3 June 2019 10 June 2019 24 July 2019
29 July 2019 5 August 2019 18 September 2019
26 August 2019 2 September 2019 16 October 2019
23 August 2019 30 August 2019 13 October 2019
21 October 2019 28 October 2019 11 December 2019

Periodic updates and renewals

Once you have received a positive EAMS scientific opinion you must provide MHRA with regular updates. The exact frequency of these updates will be agreed before the scientific opinion is issued but is likely to be every 3 months.

Use the periodic report/renewal template (MS Word Document, 347KB) and email it to eams@mhra.gov.uk to send periodic updates to MHRA.

The same template should also be used to renew your scientific opinion after a year.

Fees

The fee for the PIM designation is £3,624.

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.

Positive scientific opinions

View current scientific opinions, including public assessment reports and EAMS treatment protocols.

View expired scientific opinions.

EAMS applications: pending, refused, granted

View the number of EAMS applications pending, refused and granted.

EAMS task group and principles guidance

A government - industry stakeholder task group has produced additional EAMS guidance, including UK wide core principles

Published 18 December 2014
Last updated 18 May 2018 + show all updates
  1. Added new dates from 4 June 2018 onwards and removed old dates.
  2. New submission dates from December 2017 - October 2018 added to the page.
  3. New dates for 2017 EAMS scientific opinion submissions.
  4. Addition sates for submission added.
  5. Updated fees.
  6. Added a link to view the number of EAMS applications pending, refused and granted.
  7. First published.