Medicines, medical devices and blood regulation and safety – 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. So far there have been 13 PIM designations awarded.

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

You need to make your EAMS scientific opinion submission by 1 of the dates below:

  • 4 April 2016
  • 2 May 2016
  • 30 May 2016
  • 25 July 2016
  • 22 August 2016
  • 19 September 2016
  • 24 October 2016

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.gsi.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.