Safeguarding public health

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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

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MHRA Portal – Welcome/login page

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The eSubmissions Workspace - publications

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Downloading the application form

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Downloading the application form (cont.)

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Completing the application form

Open with Adobe Reader 7.0.5 – 8.1.0

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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

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Completing the application form cont. – Licence details

PL 99000/0001

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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

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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

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Submitting via the MHRA Portal (cont.) – New publication

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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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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=

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Confirmation from MHRA – Acknowledgement letter

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Confirmation from MHRA – Non Acceptance letter