CEMI - Centar za monitoring i istraživanje

Comparative practices in the production, registration and distribution of medicines and medical devices

04. Sep. 2016. in publications

The conditions and procedures for medicine production in Montenegro are regulated by the Rulebooks on specific requirements and methods for determining compliance with the requirements for conducting medicine production (published in the "Official Gazette of Montenegro," No. 72/15) and on specific requirements and documentation necessary for the authorization and implementation of clinical trials of medicines for use in human medicine (published in the "Official Gazette of Montenegro," No. 2/14). These Rulebooks, established by the Agency for Medicines, govern the principles of good manufacturing practice, which dictate that medicines and medical products are consistently manufactured and controlled in accordance with quality standards appropriate for their intended use. This entails monitoring both the technical and professional conditions. Specifically, the Rulebooks specify who may produce medicines, the types of facilities and equipment required, packaging requirements, and proper waste management procedures.