The process for approval of national marketing authorisation applications submitted under Article 10c of the Directive (‘simple abridged applications’) has been reviewed within the Better Regulation of Medicines Initiative.
For national applications submitted under this Article, a checklist has been devised in order to improve the quality of applications and reduce or eliminate the need for requests for further information from applicants:
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National informed consent applications - BROMI checklist 
(72Kb)
This process is not limited to over-the-counter (OTC) medicines and is applicable to all national marketing authorisation (MA) applications under Article 10c.
The following presentation was presented at the 2008 MHRA Annual Conference. It highlights the most common deficiency areas related to BROMI simple applications
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Better Regulation of Medicines Initiative (BROMI) simple applications
(831Kb)
Two mechanisms are to be introduced to facilitate approval:
Where reference licences have been maintained according to current regulatory requirements:
Applications for the new informed consent marketing authorisation that fully comply with current regulations and do not propose changes (other than MA holder, distributor, storage sites, assembler or importer, simple change of flavour or identification markings for solid oral dosage forms), should be assessed within 90 days of receipt. Requests for further information will be unnecessary for compliant applications.
In order to identify applications that meet the above criteria, please include a covering letter indicating that the application is submitted using the ‘BROMI checklist’ and attach the completed checklist to the cover letter.
Note that all applications will continue to be assessed and those that fail to comply will require amendment via request for further information and thus the timeline above will not apply. Similarly, where a change in product name is proposed, correspondence with the applicant may be required.
Where variations are required to reference licences:
UK national variations procedures have changed from 1 January 2010 and are available at:
Variations to licences
Parallel processing of variations to the reference licence alongside the new article 10c MA applications may be possible. In these cases, the cover letter for the new MA submission should include details of the variation for parallel assessment:
- Product Name
- PL Number
- Worktype (Type IB/ Type II/)
- Date of Submission.
The assessment team concerned should be contacted before submission of the parallel applications via RIS.NA@mhra.gsi.gov.uk.
Different situations can be envisaged:
- Changes that require Type 1A variations only:
Where changes required to the reference product meet criteria for Type IA variation exclusively, these should continue to be submitted and approved via the Type IA variation procedure before submission of the new MA application. - Changes that require single (standard) Type IB or Type II variation only:
Where a single Type IB or II variation is required to the reference licence to comply with current requirements, this may be processed in parallel with the Article 10c MA application by the same assessor. These can include changes to SPC, on condition that the change has been previously approved by the Agency. - Changes that require a combination of Types IA, IB and II variations:
It may be possible to group changes to the same MA as detailed in the variations guidance above. If you require advice concerning the grouping of particular changes under UK variations requirements from 1 January 2010, contact the Variations Queries helpdesk at: variationqueries@mhra.gsi.gov.uk.
For advice regarding the processing of changes to the reference product in parallel with new national simple abridged applications, please contact the assessment unit concerned with the applications: RIS.NA@mhra.gsi.gov.uk
