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Regulatory Negotiations

A small US based company with a virtual European presence had acquired a specialist pharmaceutical product. The product had an approved centralised MA, but for a variety of reasons had not been launched in the EU. There was concern that the Sunset Clause would be enacted and EMA would revoke the MA.


Reviewing the regulatory history, the management of the MA and the physical product, we determined that there was an opportunity to utilise this history to justify an extension of the Sunset Clause. This would provide sufficient time to put arrangements in place to make the product available during the extended period. This justification was constructed through review of the regulatory dossier, EMA's SOPs and the legal framework. This was put to EMA, who upon reviewing the proposal, amended their position and agreed to an extension of the Sunset period, thus allowing the product to remain viable for its planned introduction and creating substantial value for the MAH.


Please contact us for a discussion of how we can undertake Regulatory Negotiations to maximise the patient potential and value of your projects