In this section...
Who can apply?
The application must be made by the sponsor or by someone authorised to submit the request on his/her behalf. If the sponsor is not established in the European Community then he/she must have a legal representative who is.
Where do I apply?
Applicants should submit electronic documents on disk, with one PDF file for each document. Further information on the submission format can be found below. All disks should be sent to:
Information Processing Unit
Area 6
Medicines & Healthcare products Regulatory Agency
151 Buckingham Palace Road
Victoria
SW1W 9SZ
What should I send?
Full details on what to send and how the data package should be submitted can be found in the what to send section.
What are the fees and how do I pay them?
Information on the fees and how to pay them can be found on the page on Fees.
What is the timeframe?
The initial assessment will be performed within 30 days. For the purposes of this calculation, the day of receipt of the valid application by the Clinical Trials Unit is day 0. Applications for phase 1 healthy volunteer studies will be assessed and processed within an average of 14 days or less.
What are the possible outcomes?
When the application has been assessed (within 30 days) the applicant will be sent a letter informing them of one of the following:
1. acceptance of the request for a clinical trial authorisation
2. acceptance of the request for a clinical trial authorisation subject to conditions
3. grounds for non-acceptance of the request for a clinical trial authorisation.
If you have not received a letter within 35 days of sending the application, please contact RIS.CT@mhra.gsi.gov.uk.
Do I have to apply anywhere else?
All clinical trials also require a favourable opinion from an Ethics Committee. For information on Ethics Committees, please see the:
National Research Ethics Service (NRES) (external link).
The Gene Therapy Advisory Committee (GTAC) (external link)
Depending on the type of product you may also need to make an application to other bodies.
- Trials with genetically modified organisms:
Contained use of genetically modified organisms (GMOs) (external link)
- Deliberate release activities:
Department for Environment, Food and Rural Affairs (Defra) (external link) ,
- Radioactive substances:
Administration of Radioactive Substances Advisory Committee (ARSAC) (external link)
- For trials involving medical devices please contact the MHRA clinical trials for medical devices team:
Clinical trials for medical devices section.
How do I use the Voluntary Harmonisation Procedure?
In April 2009 the Clinical Trials Facilitation Group (CTFG) launched the Voluntary Harmonisation Procedure (VHP). This procedure allows sponsors of EU multi-national clinical trials to obtain a harmonised assessment of their Clinical Trial Authorisation (CTA) application by all the National Competent Authorities (NCAs) involved.
The sponsor receives a single, harmonised set of questions which have been consolidated following scientific discussion between the Lead Member State (LMS) and the other Member States concerned.
What do I need to provide?
A single set of core documents are provided electronically to the VHP coordinator and a simultaneous and coordinated assessment of the data is undertaken in fixed timelines by the Member States concerned.
Find out more
Further information on how to submit an application via VHP and the documentation required can be found in the Guidance document for a Voluntary Harmonisation Procedure (VHP) for the assessment of multinational Clinical Trial Applications, available on the CTFG section of the Heads of Medicines Agencies website (external link).
