Example of Russian Product Registration in Europe

   Russian manufacturers of medicinal products face numerous challenges trying to achieve this goal. Roughly, all these challenges can be classified into two types: obtaining importing license (in case of exporting goods from the existing production in the EEU and not CMO in the EU); obtaining product registration – Marketing Authorization.

We can tell with all responsibility, that we have dealt with 70% of those challenges in the context of registration of well-known in the EEU countries brand called Myramistin®. Particularly, the production site of LLC INFAMED K, located in Kaliningrad oblast’, Russia, is 95% prepared for obtaining importing authorization. In order to achieve this result, we facilitated 8 trial audits at the site and enforced documents preparation with respect to European standards under the guidance of dedicated experienced inspectors from Austria.

Apart from that, we assisted with discovering a European manufacturer who would be able to produce the same product for utilization in clinical studies. Previously, also on contract basis, we had managed to synthetize task specific API in the EU countries to observe European regulatory requirements to clinical trials and product registration.

   Second type of challenges emerged during approximately 30 preclinical trials carried in the EU, for all accumulated practices and procedures established in the course of previous experiments were not compatible with local regulations. After that, a series of consultations was hold with Austrian regulatory authority – AGES, that involved providing an expertise. Authorization for second phase of clinical trials was issued immediately and now the product is undergoing this stage with respect to restrictions established due to COVID-19 pandemic.

Upon the completion of phase II, future product status will be determined (RX or OTC) and requirements to phase III will be added up. Major negotiations with European insurance companies are expected for brand positioning. Registration of Myramistin® preparation is scheduled to be completed in 2023-2024. It appears to be complicated to provide a detail review within the format of case breakdown, although we are ready to share our experience with such tasks.