Special Mail 5: Guidelines on submission of applications to the MHRA

In this issue:

› Types of submissions covered
› Sending submissions
› Structuring data on disk
› Posting disks
› Labelling disks

Special MAIL 5 should be read in conjunction with the Frequently Asked Questions (version 2 - December 2007) document below.

MHRA technical validation of marketing authorisation applications (MAAs)

Amendment to article published 23 December 11

From 3 January 2012, the MRHA will be performing a technical validation of all new MAA eCTD submissions.

We will be using the Extedo EiY tool to carry out the validation and these submissions will be validated against the current EU- eCTD v3.1 validation criteria as published on the eSubmissions website (external link).

A report will be provided if there are deficiencies but, in the case of a valid submission, we will simply continue processing.

Applicants are reminded of the MHRA national requirements which require SmPCs to be submitted in the MHRA word template and for the provision of consolidated label and leaflets still apply.  As these documents are specific to the UK they should be included in the working documents folder which is outside of the eCTD sequence folder.

For further guidance on making submissions in the eCTD format please see the CMDh Best Practice Guide (external link) on the use of eCTD in the MRP/DCP.

This validation procedure will not apply to NeeS applications or variations although it is likely that is will be expanded to include these applications in 2012.

RMS Technical Validation Pilot

From 1 March 2012, an RMS validation pilot scheme will be launched by EU Competent Authorities. Under the scheme, applicants will be able to send new MAA DCP eCTD applications to the RMS for an initial technical validation check. It’s envisaged that applicants will be either by provided with a valid report which is to be sent together with their dossiers to the Concerned Member States (CMS) or, if there is a deficiency, a report detailed the deficiencies. In the case of a failed validation, the applicant will be required to resubmit a corrected application to the RMS.

An RMS validation will be accepted by all CMS – it is not envisaged that CMS carry out their own independent eCTD validation. The MHRA intended to participate in this pilot and more information on the detailed process will be provided in due course.

Participation in this pilot will be voluntary for applicants.  

For further information on technical validation on eCTD submissions please contact:

Matt Hillier
Submission Centre Team Lead
Matthew.hillier@mhra.gsi.gov.uk

Parallel Import applications - Guidance to Best Practice – May 2010

The MHRA has produced guidance outlining the common issues experienced with PLPI submissions and how to ensure that applications submitted to the MHRA are of a high standard to support quick and efficient processing.

The specific areas outlined in this document are:

• submitting a valid submission including additional information regarding Braille Labelling Requirements and Change of Ownership submissions
• fees and payment of fees
• cancellation and withdrawal of licences
• submitting a high volume of submissions and useful Agency contact points.

From Monday 7 June 2010, any submissions that do not comply with this guidance will be considered invalid and the application will need to be re-submitted in its entirety. For the Guidance to Best Practice and the forms associated with this document, please see the documents below.

Submissions in non-XML electronic Common Technical Document (eCTD) format  - 14 March 2007

To help companies move to electronic Common Technical Document (eCTD) working, the MHRA will now accept electronic submissions that are compliant with the folder structure and naming conventions of the eCTD standard but which do not have an XML backbone. For further guidance, please see the document below.

Guidelines on submission of labels and patient information leaflets - 15 October 2008

In order to further increase efficiency we have reviewed the submission standards with regard to applications containing labels and patient information leaflets (PILs) with a view to maximising the efficiency of our data input and assessment processes. Following this review we are issuing the following data format requirements for the submission of labels, leaflets and label-leaflets. For further guidance, please see the document below.