The Twinning Light Project - First Steering Committee Meeting

The first steering committee for the Twinning Light Project titled, “Strengthening the administrative capacity of the Institute for Medicines and Medical Devices of Montenegro regarding the requirements of the EU accession process” was organised virtually and brought together the Malta Medicines Authority (MMA) and the Institute for Medicines and Medical Devices of Montenegro (CInMED) Project Leaders, Component Leaders, and representatives from the European Delegation.

The meeting provided an opportunity to present the first Quarterly Report, which outlines the activities carried out between 22 January and 22 March 2025, the current challenges and plans. Additionally, the first Rolling Work Plan, collaboratively drafted by the Twinning partners and based on the findings of the preliminary assessment was approved.

The overall objective of the project is to deliver training to CInMED experts to ensure the availability of high-quality, safe, and effective medicines and medical devices in Montenegro while fostering the development of the country's pharmaceutical market. This is covered through two (2) components:

·        Component 1: Strengthening administrative capacity and internal competencies of the CInMED

·        Component 2: Recommendation for further harmonisation of the legal framework in Montenegro to achieve alignment with the EU acquis

The face-to-face project activities held from the beginning of the project included:

• 3-6 February 2025: A study tour in Malta, where CInMED experts observed a Good Manufacturing Practice (GMP) inspection.
• 19 February 2025: The project was officially launched in Podgorica, Montenegro, attended by representatives from the European Union Delegation, key officials from Malta and Montenegro involved in the project, and the Ministers of Health of Malta and Montenegro, together with the Ambassador of Montenegro.
• 10-14 March 2025: A five-day training session held in Montenegro on well-established used applications, Article 10.3 of Directive 2001/83/EC, and best practices in medicine assessments.
• 12-13 March 2025: A study tour in Malta, where CInMED experts observed a Good Distribution Practice (GDP) inspection.

Summary of implemented outputs:

• Eight (8) Short-Term Experts (STEs) are involved in face-to-face activities
• Two (2) study visits were conducted in Malta
• One (1) training workshop was held in Montenegro
• One (1) visibility event in Montenegro
• Twelve (12) working days of face-to-face activities completed
• Two (2) virtual planning meetings were conducted.

During the meeting, the partners expressed their mutual satisfaction with the successful start of the project, which brings together high-level expertise, experience, and skills to achieve the project goals sustainably. The collaboration between Member State experts and CInMED was marked by commitment and dedication. Practical solutions and assigned tasks met all mandatory results, with effective and constructive communication throughout the implementation period.