The Republic of Serbia is adopting the “Rulebook on amendments to the Rulebook on documentation and methods for importing drugs that do not have a medicine licence, i.e. medicines not registered in the register of medicines (Official Gazette of the RS no. 75/2023)” – something that is leading to a number of key changes from 14 September 2023. These include:
- Structured Import Procedures – The Medicines and Medical Devices Agency (ALIMS) has established a structured process for initiating import requests, ensuring transparency and efficiency.
- Documentation Requirements – Importers must now provide comprehensive documentation, such as product details, manufacturer certifications, and clinical trial data as appropriate to the product in question.
- Research Imports – Scientific research related imports also require detailed research plans and permits to promote responsible research practices.
- Humanitarian Aid – For humanitarian purposes, importers must specify donor and recipient details, further ensuring transparency in aid efforts.
- Ethical and Medical Compliance – Importers must comply with appropriate ethical and medical standards, obtaining approval from relevant ethics committees and healthcare professionals to justify their activities.
- Agency Approval – The Medicines and Medical Devices Agency (ALIMS) will review and approve import requests, prioritising key healthcare needs.
- Strict Control – Imported products must adhere to strict packaging and storage requirements in order to guarantee safety and efficacy.
These new provisions will help to improve Serbia’s commitment to addressing current healthcare challenges effectively while maintaining ethical and medical integrity.