Treatment with unauthorised medicinal products - compassionate use

Treatment with unauthorised medicinal products - compassionate use

Poster

Еkaterina Baldjieva, Emil Hristov, Kalina Andreevska, Zlatka Dimitrova
Faculty of Chemistry and Pharmacy, Sofia University "St. Kliment Ohridski", Bulgaria

Objective: To study the possibilities for patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who can not be treated satisfactory by an authorized medicinal products. Materials and methods: It has been used a documentary analysis of data of the European Medicines Agency, the Law on Medicinal Products in Human Medicine, Ordinance 10 of 2011on the conditions and procedure for treatment with unauthorized medicinal products in the Republic of Bulgaria, as well as on the conditions and procedure for inclusion, changes, exclusion and supply of medicinal products from the list under Article 266a(2) of the Medicinal Products in Human Medicine Act. Results: Compassionate use provides treatment with unauthorized medicinal products. The medicinal product concerned must either be the subject of an application for a marketing authorization or must be undergoing clinical trials. The European Medicines Agency provides recommendations through the Committee for Medicinal Products for Human Use, but these do not create a legal framework. Compassionate use programs are coordinated by Member States, which set their own rules and procedures. Most Member States have developed Guidance for Compassionate Use containing detailed information on the rules for compassionate use of medicinal products. Conclusion: The Compassionate Use programs provide patients with easier access to new treatment option currently under development.
Keywords: compassionate use, unauthorised medicinal products