At the end of 2022, the Bulgarian national council on prices and reimbursement of medicinal products has launched an application which faciliates review of registered price of medicinal products by trade name or by international non-proprietary name. Such review is available only for medicinal products that are included in the Positive Medicinal List. There is also an additional possibility to scan the barcode from the packaging of the medicinal product, as the mobile application uses real-time data from the registered prices of medicinal products database. Further information can be found here: https://ncpr.bg/bg/%D0%BF%D0%BE%D1%81%D0%BB%D0%B5%D0%B4%D0%BD%D0%B8-%D0%BD%D0%BE%D0%B2%D0%B8%D0%BD%D0%B8.html (available only in Bulgarian) and the link to Goodle store download can be found here: https://play.google.com/store/apps/details?id=com.sirma.drugprices.drug_prices_online

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