Official completion of the EU Twinning Light Project 

The final event held in Montenegro on 22 September 2025 marked the successful conclusion of the EU-funded Twinning Light Project “Strengthening the administrative capacity of the Institute for Medicines and Medical Devices of Montenegro regarding the requirements of the EU accession process.”

The project, jointly implemented by the Malta Medicines Authority (MMA) and the Institute for Medicines and Medical Devices of Montenegro (CInMED), was launched in January 2025 and has since delivered substantial results in enhancing CInMED capacity to ensure the availability of high-quality, safe, and effective medicines and medical devices in Montenegro while supporting alignment to European standards.

The project was structured around two core components:

1. Component 1: Strengthening administrative capacity and internal competencies of CInMED
2. Component 2: Recommendations for further harmonisation of the legal framework in Montenegro to achieve alignment with the EU acquis

The Twinning Light Project successfully combined exchange of knowledge, capacity building and legal harmonisation efforts throughout its implementation. The key achievements include:

• Thirty-four (34) Short-Term Experts (STEs) were involved in face-to-face activities
• Ninety-two (92) cumulative training instances for CinMED
• Nine (9) study visits were conducted in Malta
• Seven (7) training workshops were held in Montenegro
• One hundred and three (103) working days of face-to-face activities were completed
• Three (3) Steering Committee meetings were successfully organised
• All targets were achieved (16), of which eight (8) were exceeded

The face-to-face project activities provided CInMED employees with practical training and first-hand exposure to EU standards, including Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) inspections, as well as workshops on regulatory processes and marketing authorisation assessments.

The European Delegation to Montenegro, MMA, and CInMED expressed mutual satisfaction with the project’s outcomes and reaffirmed their dedication to further cooperation in strengthening Montenegro’s healthcare and regulatory systems in the context of the EU accession process.

This success is the result of continuous effort, collaboration, and dedication from all parties involved. As this chapter closes, the MMA looks forward to welcoming our CInMED colleagues into the European Union regulatory network. Together, we will continue working towards our shared goal: ensuring patient safety through excellence in regulation.