Better Regulation of Medicines: National informed consent (Article 10c, 'simple abridged') applications

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:
› National informed consent applications - BROMI checklist (65Kb)

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
› 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:
Parallel processing of variations to the reference licence alongside the new article 10c MA has also been considered. 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/ Type II BROMI), Date of Submission.

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. Work type and timetables for these variation procedures are unchanged.

When completing electronic application forms, please note the new variation work types 'Type 1A/1B BROMI' apply to the separate BROMI variations initiative. The work types 'Type 1A', 'Type1B' and 'Type II' will continue to be applicable to these parallel submssions.

Changes that require combination of Types IA, IB and II variations:
Those changes that would otherwise require several separate Type IA/B or Type II (standard) variations may be combined into a single Type II (standard) variation. These can include changes to SPC, on condition that the change has been previously approved by the Agency. A new worktype ‘Type II-BROMI’ will be created in order to track these applications. The Type II (standard) fee will apply. 

For applications submitted via the MHRA Portal, the worktype dropdown in section 1.b. of the form will not initially include the new worktype and the current ‘Type II’ worktype should be used.  In these cases, the worktype ‘Type II BROMI’ should be stated in the ‘Scope’ section of the form. The fee type in sections 2a and 8 of the portal form will remain as ‘VAR TYPE 2 NAT’.

A single variation application should be submitted including all qualifying proposed changes. Reference to the PL number of the parallel new marketing authorisation application should be included in the section ‘Background for change etc…’. All changes should be described in ‘present’ and ‘proposed’ section of the form. Any changes in SPC wording should be stated here in full, in preference to ‘see attached SPC’.

Changes that would otherwise require separate Type IA/B variations should be indicated in the appropriate section of the application form, however, those ‘Type II BROMI’ variations submitted via the Portal will currently be unable to access these fields and the description of these changes should be clearly stated in the ‘Scope’ section of the form, in line with the change categories. Data requirements for changes that would otherwise be handled as separate variations are unchanged from those described in the Regulation and failure to comply with these requirements may result in refusal of the application.

For variation applications to be assessed in parallel with a new MA application, the covering letter should clearly state details of; Product name, PL number and date of submission of the new MA application. The same details should be included in the ‘Background’ section of the variation application form.

The time to approve applications submitted in parallel with variations to reference licences will be dependent on issues that arise during the variation assessment and the workflow will follow the variation timetable. However, the new MA will be granted as soon as possible after approval of the variation to the reference licence.

National informed consent (Article 10c, 'simple abridged') applications will be accepted under these proposals from 1 February 2007. Applications received will be audited within six months and the outcome reported on the MHRA website.

For further information, please contact Keith McDonald, Licensing Division, e-mail keith.mcdonald@mhra.gsi.gov.uk.