Apply for the early access to medicines scheme (EAMS)
- Medicines and Healthcare products Regulatory Agency
- Part of:
- Patient safety and Marketing authorisations, variations and licensing guidance
- 18 December 2014
- Last updated:
- 16 January 2017, see all updates
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:
- the promising innovative medicine (PIM) designation
- 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.
See guidance on applying for a PIM designation (PDF, 187KB, 3 pages) .
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.
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
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 email@example.com.
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|
|30 January 2017||6 February 2017||22 March 2017|
|27 February 2017||6 March 2017||19 April 2017|
|27 march 2017||03 April 2017||17 May 2017|
|1 May 2017||8 May 2017||21 June 2017|
|29 May 2017||5 June 2017||19 July 2017|
|24 July 2017||31 July 2017||13 September 2017|
|21 August 2017||28 August 2017||11 October 2017|
|18 September 2017||25 September 2017||8 November 2017|
|23 October 2017||30 October 2017||13 December 2017|
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.
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.
EAMS applications: pending, refused, granted
EAMS task group and principles guidance
Published: 18 December 2014
Updated: 16 January 2017
- New dates for 2017 EAMS scientific opinion submissions.
- Addition sates for submission added.
- Updated fees.
- Added a link to view the number of EAMS applications pending, refused and granted.
- First published.