1. Safeguarding public health © Crown copyright 2008 BROMI eSubmissions Case study using the MHRA Portal : Tesfa Rodway – Information Systems Training Officer Samuel Augustus – Senior Scientific Classifier Medicines and Healthcare products Regulatory Agency BROMI Variations Launch Conference - May, 2008

2. Slide 2BROMI Variations Launch Conference © Crown copyright 2008 MHRA Portal – Welcome/login page

3. Slide 3BROMI Variations Launch Conference © Crown copyright 2008 The eSubmissions Workspace - publications 123

4. Slide 4BROMI Variations Launch Conference © Crown copyright 2008 Downloading the application form

5. Slide 5BROMI Variations Launch Conference © Crown copyright 2008 Downloading the application form (cont.) 12

6. Slide 6BROMI Variations Launch Conference © Crown copyright 2008 Completing the application form Open with Adobe Reader 7.0.5 – 8.1.0

7. 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

8. Slide 8BROMI Variations Launch Conference © Crown copyright 2008 Completing the application form cont. – Licence details PL 99000/0001 12345

9. Slide 9BROMI Variations Launch Conference © Crown copyright 2008 Completing the application form cont. – Adding multiple licences – Bulk submissions 1 st product for change (full fee) a. Fee Type: BROMI PL Var – Self-Certification 2 nd and subsequent products for change (bulk reduced fee) a. Fee Type: BROMI PL Var – Self-Certification – Bulk

10. Slide 10BROMI Variations Launch Conference © Crown copyright 2008 Submitting via the MHRA Portal – Document preparation You may Zip the supporting documentation YOU MUST NOT ZIP THE APPLICATION FORM!! Special MAIL 5 naming requirements ZIP files

11. Slide 11BROMI Variations Launch Conference © Crown copyright 2008 Submitting via the MHRA Portal (cont.) – New publication

12. Slide 12BROMI Variations Launch Conference © Crown copyright 2008 M1-2-form.pdf Supporting_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. 1 2 345

13. Slide 13BROMI Variations Launch Conference © Crown copyright 2008 8 digit identifier Confirmation from MHRA Once 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=

14. Slide 14BROMI Variations Launch Conference © Crown copyright 2008 Confirmation from MHRA – Acknowledgement letter

15. Slide 15BROMI Variations Launch Conference © Crown copyright 2008 Confirmation from MHRA – Non Acceptance letter