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Case Study
Example of experience of the use of the
Mutual Recognition Procedure.
The following is an actual example of the type of application
for which staff at Ivowen have been responsible.
A large Mutual Recognition Procedure
(MRP) involving seven separate independent customers,
many of whom had multiple sites of manufacture/distribution,
etc., in different member states. There were 10 separate Concerned
Member states (CMSs) - with multiple applications in many
of the CMSs. In addition to the MRP there were also multiple
national applications in the Reference Member State (RMS).
The regulatory strategy was developed by taking patent expiry
dates, data exclusivity dates, SmPC differences in different
member states and the customers needs including their requirements
for packaging, batch release and distribution into consideration.
Of primary importance during the procedure was meeting the
needs of the customers in a timely fashion and working in
a positive and co-operative way with the RMS.
This example is one of many MRPs for which we have been responsible,
although it was the largest and most complex.
Brief description of the project:
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Product:
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Generic beta-blocker tablet, 2 strengths
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Reference Member State:
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The Netherlands
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Concerned Member States:
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UK, France, Austria, Germany, Ireland, Finland, Sweden,
Belgium, Luxembourg, Spain
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No. of Duplicate licences in RMS:
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9, resulting in 9 parallel MRPs
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No. of individual customers involved in CMSs:
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7
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Outcome :
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MRP completed successfully in all CMSs
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Total number of licences issued for the product:
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Approx. 96
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