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Safeguarding public health
© Crown copyright 2008
BROMI eSubmissionsBROMI eSubmissionsCase study using the MHRA PortalCase study using the MHRA Portal::
Tesfa Rodway – Information Systems Training OfficerSamuel Augustus – Senior Scientific Classifier
Medicines and Healthcare products Regulatory AgencyBROMI Variations Launch Conference - May, 2008
Slide 2BROMI Variations Launch Conference
© Crown copyright 2008
MHRA Portal – Welcome/login page
Slide 3BROMI Variations Launch Conference
© Crown copyright 2008
The eSubmissions Workspace - publications
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Slide 4BROMI Variations Launch Conference
© Crown copyright 2008
Downloading the application form
Slide 5BROMI Variations Launch Conference
© Crown copyright 2008
Downloading the application form (cont.)
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Slide 6BROMI Variations Launch Conference
© Crown copyright 2008
Completing the application form
Open with Adobe Reader 7.0.5 – 8.1.0
Slide 7BROMI Variations Launch Conference
© Crown copyright 2008
Completing the application form (cont.)Complete all required areas on the application form – See examples of completed application forms – Add Pack Size & Company Address Change
Slide 8BROMI Variations Launch Conference
© Crown copyright 2008
Completing the application form cont. – Licence details
PL 99000/0001
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Slide 9BROMI Variations Launch Conference
© Crown copyright 2008
Completing the application form cont. – Adding multiple licences – Bulk submissions
1st product for change (full fee)a. Fee Type: BROMI PL Var – Self-Certification
2nd and subsequent products for change (bulk reduced fee) a. Fee Type: BROMI PL Var – Self-Certification – Bulk
Slide 10BROMI Variations Launch Conference
© Crown copyright 2008
Submitting via the MHRA Portal – Document preparation
You may Zip the supporting documentationYOU MUST NOT ZIP THE APPLICATION FORM!!
Special MAIL 5 namingrequirements
ZIP files
Slide 11BROMI Variations Launch Conference
© Crown copyright 2008
Submitting via the MHRA Portal (cont.) – New publication
Slide 12BROMI Variations Launch Conference
© Crown copyright 2008
M1-2-form.pdfSupporting_Documents.zip
Submitting via the MHRA Portal (cont.) - New publication
Clicking ‘Save’ will create a new publication and the files attached are submitted to MHRA. The publication created will allow for subsequent communication between the company and MHRA for that particular application.
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Slide 13BROMI Variations Launch Conference
© Crown copyright 2008
8 digit identifier
Confirmation from MHRAOnce you have made a submission to the MHRA (by creating a publication) you will receive an email receipt from the MHRA Portal to confirm that your submission has been sent.
For Self Certification applications, the change can be implemented upon receipt of the e-mail, however an acknowledgement letter will be sent within 14 days. You may implement the change prior to receipt of the letter at your own risk, as the application may be subsequently invalidated and a non acceptance letter sent.
• The 8 digit identifier may be requested by the Portal Manager team to be able to assist you with an enquiry.
• N.B. the 8 digit identifier are the numbers that follow the i=
Slide 14BROMI Variations Launch Conference
© Crown copyright 2008
Confirmation from MHRA – Acknowledgement letter
Slide 15BROMI Variations Launch Conference
© Crown copyright 2008
Confirmation from MHRA – Non Acceptance letter