We would like to inform you that in the process of bringing the registration dossier into compliance with the requirements of the EAEU and further mutual recognition, some problems have arisen, for the solution of which we offer the following:
Where the registration dossiers of the medicinal products have complied with the requirements of EEC Council Decision No 78 of 3 November 2016 prior to the entry into force of EEC Council Decision No 34 of 23 April 2021, apply for mutual recognition only after making the necessary changes to the registration dossier in the reference country. It should be taken into consideration that these changes will be possible only after the expected changes in the EEC Council Decision No. 78 of 3 November 2016 enter into force.