Herman-Medical is committed to providing expert advice on Regulatory Affairs and Project Management to the generic pharmaceutical industry.
Herman-Medical can provide regulatory affairs support as consultants to pharmaceutical companies based in the European Union, in EU accession states and worldwide on the successful development and timely registration of their products in the EU and other markets.
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.