Avva Pharmaceuticals Ltd. submitted a marketing authorisation application for Micrazym to the Netherlands for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance the Netherlands) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States’, in this instance Austria, Belgium, Cyprus, Czechia, Denmark, Finland, Germany, Ireland, Luxembourg, Norway, Slovakia, Spain and Sweden), where the company has applied for a marketing authorisation.

However, the Member States were not able to reach an agreement and the Dutch medicines agency referred the matter to EMA for arbitration on 21 December 2023.

The main grounds for the referral were concerns raised by the Spanish and German medicines agencies regarding the evidence provided by the company to show that the medicine behaves in the same way as an authorised medicine called Creon which also contains porcine pancreas enzymes in gastro-resistant capsules and for which adequate data on safety and efficacy are documented in the literature.

The company provided results from in vitro (laboratory) studies to measure how both medicines dissolve (which, among other things, affects how the medicines behave in the body), and compared these results with those for similar authorised medicines. Spain and Germany considered that this approach was not in line with relevant guidelines and that the data presented were not sufficient to demonstrate that Micrazym will behave as expected in the intestine.