The Ministry of Health has called on pharmaceutical companies to take action to improve access to naloxone in Bulgaria. The medicine can quickly counteract the life-threatening effects of an overdose with fentanyl and other opioids, including dangerous respiratory depression.
“In an opioid overdose, every minute counts“, the Ministry of Health said.The ministry said that companies that hold permits for the use of medicinal products containing naloxone must submit an application for setting a maximum price in Bulgaria. This is done before the National Council for Prices and Reimbursement of Medicinal Products.
According to the Ministry of Health, the procedure is simpler compared to including a medicine in the Positive Medicines List. Fewer documents are required, and the administrative fee is lower. The aim is to create conditions for the medicine to be available in situations where the reaction must be immediate.
The National Council for Prices and Reimbursement of Medicinal Products indicates that the applicant may be the holder of the marketing authorization or his authorized representative. The application may be submitted electronically, at a counter or through a licensed postal operator.
The deadline for performing the service is 30 days from the submission of the application. Under the published procedure, the fee for evaluating the documentation for forming a maximum price is 750 leva. After the Council's decision, the approved price is entered into the public register of maximum prices for medicinal products.
So far, the Ministry of Health has not identified a specific company that has submitted an application for determining the price of naloxone. The agency states that it relies on the active participation of the pharmaceutical sector to ensure a timely response to overdoses with fentanyl and other opioids.