With the support of the EU, capacities of the Institute for Medicines and Medical Devices of Montenegro have been enhanced

Montenegro and Croatia successfully completed the EU Twinning project "Support to the Institute for Medicines and Medical Devices of Montenegro (CInMED)"

The conference held in Podgorica, on 19 July 2022, marked the successful completion of the Twinning project "Support to the Institute for Medicines and Medical Devices of Montenegro (CInMED)". The project, financed by the European Union and implemented by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED), strengthened CInMED’s institutional capacities and visibility, enhanced pharmacovigilance and medical devices surveillance systems, and improved authorisation and inspection systems for medicines and clinical trials in Montenegro.

Through this project, the Republic of Croatia, as a Member State of the European Union (EU), provided technical support to CInMED in the process of harmonising operations and legislation with international standards and the Union acquis in the field of medicines and medical devices, not only as a part of the European integration process, but also to improve the health care system and patients’ protection in Montenegro.

The conference was opened by Asst. Prof., MD Snežana Mugoša, Beneficiary Country Project Leader and Managing Director of CInMED, thanking all the participants who contributed to the successful implementation of the project and highlighting the excellent cooperation with the partner institution, the Agency for Medicinal Products and Medical Devices of Croatia. "The project is essentially a continuation of our long-standing successful cooperation, during which HALMED became our partner and support on the way to the European Union, as well as a role model that we look up to when it comes to applying the highest EU and international standards in our work and building Institute's potentials and credibility," said Mugoša.

Lina Čačić, Resident Twinning Advisor on this project and HALMED employee, presented the results of the project and highlighted the most important activities. CInMED's strategic, action and communication plans were developed, as well as the training programme for its employees. Rulebooks and guidelines in the field of medicines and medical devices, standard operating procedures and manuals for conducting inspections were prepared, as well as educational materials intended for promoting CInMED's contribution to public health. CInMED employees were provided with the knowledge and practical experience of Croatian colleagues in the form of lectures, workshops and conduction of inspections. A meeting with the representatives of associations of healthcare professionals and patients in Montenegro, persons in charge of communication in healthcare, as well as media representatives was held, with the aim of promoting the significance of continuous monitoring of medicines safety in Montenegro. Two study visits of Montenegrin experts to the Republic of Croatia were also organized. They visited HALMED and participated as observers in the good distribution practice inspection of a wholesaler of medicines.

The Program Manager of this project at the EU Delegation, Dobromir Hristov, said that he believes that the successful work done under this project has far more reaching effects in reality: "Ensuring the high standards of medical products and medical devices are key piece in the overall puzzle, protecting the Montenegrin and EU citizens against harmful products and practices. Thus, I hope that building on the achievements of the project, the Montenegrin authorities will be able to preserve the high level of standardisation and accreditation necessary to be up to the latest in the EU on the path to accession."

Director of HALMED and Member State Project Leader, Prof. Siniša Tomić, stated that impressive results were achieved through this project, but that the EU regulatory rules are constantly changing and improving, therefore CInMED and other Montenegrin institutions that monitor medicines and medical devices in Montenegro face more challenges in order to ensure their market has a suitable regulatory framework harmonized with EU legislation. "Through the exchange of knowledge, our experts carried out an intensive adaptation of comprehensive rules and guidelines to EU standards. I can conclude that the Union acquis has been continuously implemented during this cooperation and will continue to be applied in the development of CInMED's institutional and regulatory capacities," said Prof. Tomić.

EU Twinning projects are a very important mechanism for transferring the knowledge of European Union Member states to candidate countries in the specific areas important for the EU accession process. "This is the sixth of a total of seven Twinning projects in Montenegro that have so far been implemented by Croatian institutions," said the Ambassador of the Republic of Croatia in Montenegro, H.E. Veselko Grubišić. He emphasized the commitment of the Republic of Croatia to helping Montenegro in the process of integration into the EU family and encouraged Montenegrin institutions to get more involved in EU projects and maximise the advantages they provide.

The conference was attended, among others, by representatives of the Ministry of Health of Montenegro, headed by Minister Dragoslav Šćekić, the Ministry of Economic Development and Tourism of Montenegro, the Ministry of European Affairs of Montenegro, the Directorate for Finance and Contracting of the EU Assistance Funds (CFCU) within the Ministry of Finance, Ministry of Foreign and European Affairs of the Republic of Croatia, Central Finance and Contracting Agency of the Republic of Croatia, and representatives of CInMED and HALMED.  

The project was financed by the European Union in the amount of 340,000 euros and co-financed by Montenegro in the amount of 60,000 euros, for the duration of 18 months, from January 2021 to July 2022.