In this section...
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EudraCT V8 EudraCT V8 is now available, please refer to the guidance provided on the EudraCT website (external link) for details of the new features. Please note; IRAS is due to be upgraded within the next few weeks, please refer to the IRAS website (external link) for guidance. MHRA will accept version 7 application forms during this time, however users are encourage to upgrade their application forms to version 8 using the XML conversion tool available on the EudraCT website (external link) and complete the additional fields before submitting. |
What to send
Details on the documentation required in a CTA application are available in:
In order for an application to be considered as valid, a submission should contain a file for each of the following documents:
- Covering letter
- Clinical Trial Application + valid xml
- Protocol
- IB or document replacing the IB
- IMPD/simplified IMPD
- NIMP Dossier (if required)
- Scientific advice - A summary of scientific advice from any Member State or the EMA with regard to the clinical trial (if available).
- EMA Decision - A copy the EMA’s Decision on the decision of the Paediatric Investigation Plan and the opinion of the Paediatric Committee (if applicable).
- The content of the labelling of the IMP (or justification for its absence)
- Proof of payment
- Manufacturer’s authorisation or Importer’s authorisation plus QP declaration on GMP for each manufacturing site.
In cases where a document is not required in support of an application, for example the type of submission does not require details of the content of the labelling, the file should still be provided. However, it should contain an explanation for why the document has not been supplied.
Our Information Processing Unit will be using the above list to validate your application; any application which does not contain a file for each of the documents listed above will be rejected.
Please see our additional information section for more guidance on these documents.
Submitting your application
Applicants are required to submit electronic documents on disk with one PDF file for each document. In exceptional cases where the use of PDF files is not feasible, (for example, in the case of small, non-commercial clinical trials) electronic documents using Word are acceptable and will be processed to the same target timescales. Disks should be submitted with no subdirectory structure. The portal is not available for clinical trial submissions at this time. Updates on portal availability will be provided in due course.
Each disk should be labelled in the following manner:
- EudraCT number
- Description of contents eg
-
- Initial Application
- Response to Remarks from an Initial Application
- Company name
- Date sent
The disk may be printed or labelled with an adhesive paper label or a permanent marker pen.
All disks should be sent to the address below:
Information Processing Unit
Area 6
MHRA
151 Buckingham Palace Road
Victoria
SW1W 9SZ
When the MHRA receives an application for a clinical trial authorisation (CTA), it will be validated. If the application is not valid (eg incomplete information is supplied) then the person making the application will be contacted and told that there are deficiencies. If the deficiencies are minor, you may be asked to provide the missing information. Nothing will happen to the application until the missing components are provided, although once the application is complete it will be processed as normal.
If the deficiencies are major, you may be required to resubmit a complete application. Once the application is valid (ie complete) the assessment period will begin and an acknowledgement letter will be sent to the person submitting the application. This is the person named in Section C1 of the clinical trial application form. The assessment period starts from the date of receipt of a valid application. If you have not been told that your application is invalid or received an acknowledgement letter within 10 days of sending the application, please contact RIS.CT@mhra.gsi.gov.uk
Guidance on preparing PDF documents
As far as possible all data should originate from electronic files rather than from scanned data. There may be circumstances where the data is only available in paper format, please advise us in advance if this is the case by sending an email to RIS.CT@mhra.gsi.gov.uk.
In order to process PDF documents efficiently MHRA assessors need to be able to easily navigate and manipulate the document (eg copy and pasting sections of the document or splitting a large document into multiple smaller documents). To facilitate this process the following points should be noted when creating PDF documents:
- the covering letter, protocol, IMPD and IB should be created directly from Word or undergo Adobe Acrobat optical character recognition (OCR) at the time of creation. PDF document scanned images should be avoided as it is not possible to cut-and-paste data in this format. PDF documents should not be file protected as this prevents the printing and manipulation of the document
- fonts that are not supported by Microsoft Word should not be used on PDF documents
- all PDF documents should be appropriately bookmarked to ensure that assessors can jump directly to the sections of interest. Only the simplest of PDF documents (eg a letter) should be submitted without bookmarks. All documents larger than 50 pages should be bookmarked (bookmarking to primary headings is sufficient). Documents less than 50 pages should be considered for bookmarking if they are particular complex and/or require frequent cross referencing within the document. In making this judgement consider whether bookmarking would help the assessor to work more efficiently
- supporting data and references should comply with the Vancouver convention (external link) where appropriate.
If historical documents are not available electronically, a scanned image which has undergone OCR is acceptable. Applicants should ensure that the highest quality scan image is produced.
Disk formats
The following disk formats are acceptable:
- CD-ROM
- CD-R
- CD-RW
- DVD-R
- DVD-RW.
Note: Only one application should be submitted per disk.
The following formats are not acceptable:
- DVD-ROM
- DVD-RAM.
Naming documents
It is important that the individual document filenames allow our staff to quickly identify where the document should be indexed on our system. Please give the document a simple, relevant and descriptive name (eg Application form, IMPD, Clinical Study report etc).
Examples of acceptable filenames are provided below:
| Device(s)/Type | Document filename |
|---|---|
| General | |
| Covering letter | covering-letter |
| Application form | application-form |
| EudraCT XML file | XML-file |
| Proof of payment | proof-of-payment |
| Copy of Ethics Committee opinion in the MS concerned (where available) | ethics-committee-opinion |
| Copy/summary of any scientific advice | scientific-advice |
| EMA PIP agreement and/or Paediatric Committee opinion if applicable | PIP-agreement |
| Protocol Related | |
| Clinical trial protocol with all amendments to date | protocol |
| IMP Related | |
| Investigator’s brochure | investigators-brochure |
| Investigational Medicinal product Dossier (IMPD)1 | impd |
| Simplified IMPD for known products1 | simplified-impd |
| Summary of Product Characteristics (SmPC) (for products with marketing authorisation within the EC)1 | smpc |
| Non-IMP Dossier | nimpd |
| Copy of the manufacturing authorization stating the scope of the authorisation (where applicable) | manufacturers-authorisation |
| Certification of the importers QP that the manufacturing site works in compliance with GMP at least equivalent to EU GMP (where applicable) | qp-declaration |
| TSE certificates (when applicable) | tse-certificate |
| The content of the labelling (where applicable) | label |
1. Where there is more than one IMPD, simplified IMPD or SmPC used in the trial, the files should be named “impd- <name-of-product>
All queries relating to electronic documents and submissions should be directed to: RIS.CT@mhra.gsi.gov.uk
