As of 21.08.2022, a new Annex 21 "Imports of medicinal products" of the European Guide to Good Manufacturing Practice (EU GMP Guide) comes into force. According to Annex 21, once a batch of a medicinal product has been physically imported in a EU/EEA country, including clearance by the custom authority of the entrance territory, it is subject to the Qualified Person (QP) certification or confirmation. For more details on this update please follow this link: https://ec.europa.eu/health/latest-updates/eudralex-volume-4-eu-guidelines-good-manufacturing-practice-medicinal-products-human-and-veterinary-2022-02-21_en

After 9^th November 2020, the requirement to submit sequences on electronic media (CD/DVD) will be waived for all procedures submitted through CESP. For all other procedures (marketing authorizations, renewal of marketing authorizations, variations) for which the dossiers (sequences) have not been submitted through CESP, this requirement remains valid.

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

With decision No. 660 of 18 September 2014 adopted by the Council of Ministers in Republic of Bulgaria, a new Chairman of the National Council of prices and reimbursement of medicinal products was elected. The highly acclaimed pharmacologist prof. Nikolay Dantchev, who is a leading expert in the field, has been selected to take the role of a Chairman of the National Council. He is also a Vice Dean in the Pharmaceutical Faculty at Medical University in Sofia and has over 120 scientific publications in the sphere of pharmacy.