A variation allows the applicant to apply for changes to a marketing authorisation. Changes are classed either as minor changes which include Type 1A or Type 1B variations, or as a major change classed as a Type II.
The invalidation of a variation submission is an area which both the agency and industry would like to see reduced. One of the top five common invalidation errors for Type 1B/II is incorrect fees being paid for a submission. The calculator aims to reduce this validation issue considerably.
Last year saw the launch of the MHRA ‘Initial Fees Calculator’ and since then, we have been working on introducing a Variations version of the ‘Fee Calculator’, using the original initials format as a basis for the variations calculator.
As there is a large range of fees which cover many submission types, we looked in to creating a simple and accessible calculator which could provide a total in the least possible number of steps.
The 'Variations Fees calculator' acts as a guide and covers procedure types and a range of variation submissions, including Traditional Herbal Remedies (THR), Homeopathic, Reference Member State (RMS), Concerned Member State (CMS), groupings and bulking of licences.
There are some fee areas which are not covered by the calculator and one of these is the Composite Coordinated Collection (CCC) procedure. Using this as an example, the fee structure of the current calculator could not comfortably accommodate the CCC procedure. This is because there is a need to calculate totals throughout the CCC structure (including groupings and Product Information Quality (PIQ)) then add and present those totals as a single fee. Within the confines of the current variations calculator, this would have created a complex platform and also have made an extremely bulky calculator. It was decided to look in to a separate calculator for the CCC procedure.
Our project to create a separate calculator for the CCC procedure is ongoing. We will keep you updated with our progress.
Comment below if you have any suggestions on how we could further improve our calculators.
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2 comments
Comment by Stefan posted on
We have recently received an email from the MHRA that a new "Pay-on-invoice" pilot is to be rolled out from 1st April 2017. Several Member-States already use this approach and it proves successful in that applicants are not required to look for specific national fee requirements, which are not always straightforward and thus companies avoid delays as a result of invalidations regarding incorrect fees. In this context, will the MHRA continue to work on the Initial and Variations fee calculator and is the "pay-on-invoice" likely to be adopted?
Comment by sarahroseburke posted on
Stefan, thank you for your comment. We will continue, for the foreseeable future, to update and maintain the Initial and Variation Fees Calculator. This will enable industry to plan ahead for both national and EU submissions where fees are concerned.