On 4 July 2018 the European Medicines Agency (EMA) granted an SME rating to Mikrobiomik.
SME (Small and Medium-Sized Enterprises) status means regulatory, financial and administrative support at all stages of the development of medicines. For details of the actions covered by that support, seat this EMA website page.
The EMA supports innovative organisations such as Mikrobiomik and is one of the main drivers of the development of new pharmaceuticals in Europe.
Its main remit lies in the authorisation and monitoring of medicines in the EU. Firms wishing to market their products must apply for authorisation for each one, which is issued (if granted) by the European Commission. That authorisation permits them to market the medicines in question throughout the EU and the EEA. Given the broad scope of these centralised procedures, most truly innovative medicines marketed in Europe are authorised by the EMA.