After January 28 2022, your company must be registered with OMS before submission of application or amendment to distribution or manufacturing authorization (as well as authorization for wholesale of medicinal products) to Bulgarian drug agency.
More information on OMS and its functionality can be found here: https://www.ema.europa.eu/en/human-regulatory/research-development/data-medicines-iso-idmp-standards/spor-master-data/organisation-management-service-oms