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.


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

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

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 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
06 May 2019 13 May 2019 26 June 2019
03 June 2019 10 June 2019 24 July 2019
29 July 2019 05 August 2019 18 September 2019
26 August 2019 02 September 2019 16 October 2019
23 September 2019 30 September 2019 13 November 2019
21 October 2019 28 October 2019 11 December 2019
09 December 2019 16 December 2019 29 January 2020
06 January 2020 13 January 2020 26 February 2020
03 February 2020 10 February 2020 25 March 2020
09 March 2020 16 March 2020 29 April 2020
06 April 2020 13 April 2020 27 May 2020
04 May 2020 11 May 2020 24 June 2020
01 June 2020 08 June 2020 22 July 2020
27 July 2020 03 August 2020 16 September 2020
24 August 2020 31 August 2020 14 October 2020
21 September 2020 28 September 2020 11 November 2020
19 October 2020 26 October 2020 09 December 2020

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 to send periodic updates to MHRA.

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


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 26 April 2019 + show all updates
  1. Change in dates under 'Dates for submission Day 1 and Day 45'
  2. Added new dates from 4 June 2018 onwards and removed old dates.
  3. New submission dates from December 2017 - October 2018 added to the page.
  4. New dates for 2017 EAMS scientific opinion submissions.
  5. Addition sates for submission added.
  6. Updated fees.
  7. Added a link to view the number of EAMS applications pending, refused and granted.
  8. First published.